For each trial phase and opportunity area, users can click to learn more and find additional resources.
Participant Perspective
- What is a clinical trial?
- How do I know if a clinical trial is right for me?
- How do I find a clinical trial?
- How do I provide input into trial design?
- What options do I have to make clinical trial participation easier for me?
- How do I provide ongoing feedback about my participation?
- What are my results?
- How were my results used / how did they further research?
- How do I give feedback on my trial experience?
Personalized Clinical Trials Opportunities
Pre-Trial
Drive Awareness
Consider increasing the use of information channels to raise awareness of clinical trials
Opportunity
Knowledge of clinical trials as a treatment option may be limited or lacking among patients, especially underrepresented populations. The use of multiple channels, such as community partners, social media, or physicians, to raise awareness about clinical trials allows the flow of information on this topic to patients who may not otherwise be aware of or consider clinical trial participation in order to support improved recruitment.
Considerations to Help Action the Opportunity
- Develop a cohesive strategy for use of information channels to increase awareness and education around clinical research and clinical trial opportunities
- Co-create tools and informational assets (resources) for the channels with the intended users (e.g., patients, care partners, healthcare providers). Potential examples include materials to support clinical trial conversations, digital media in systems already used by patients (e.g., medical record systems, social media, etc.), materials / forums for use in community settings, etc.
- Partner with trusted sources of information for the patient, such as healthcare providers, community groups, and patient organizations, etc. to support provision of information and conversations with patients that are relevant and seek feedback to make meaningful adjustments
Value and Potential Benefits
- Increases awareness of clinical trials
- Encourages patients to have conversations with their health care providers about clinical trials as a treatment option to help identify clinical trials they can participate in
- Improves diversity and inclusion by engaging with patient populations that are previously underrepresented in our clinical trials
- Improves retention, as patients may be better informed ahead of clinical trial participation and therefore have more time to make an informed decision (e.g., fewer unknowns or surprises for the patient)
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
Exploring the Impact of Shared Decision Making in Clinical Trial Consideration (Clinical Conversations White Paper #1) |
This paper explores shared decision-making in patient-provider conversations with the aim to enable patients to better understand clinical trials as an option. |
TransCelerate BioPharma, Inc. |
|
Clinical Research Awareness: A Proposed Study Design to Assess the Role of Shared Decision Making in the Consideration of Clinical Trial Participation (Clinical Trials Conversations White Paper #2) |
This paper aims to enable researchers to assess the value and measures the impact of Shared Decision Making (SDM) on patient and HCP satisfaction. |
|
|
One Person Closer, an on on-line social campaign, is designed to put a human face on research and development by sharing the personal stories of researchers, HCPs and patients who have contributed to clinical research and the development of medical breakthroughs. The photojournalist campaign aims to show doctors, nurses and other HCPs that they can help facilitate research that advances science and that may benefit their patients. |
||
|
Diversity Community-Based Site Engagement and Capacity Building
|
This solution provides an aggregated collection of insights and perspectives from the attending organizations of a June 9 Roundtable Event, regarding considerations that sponsors, sites, and others have taken to enhance engagement and capacity building for community-based sites. |
|
|
Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT)
|
The Site Engagement and Capacity Building Considerations supports efforts to facilitate meaningful inclusion of diverse patient populations in clinical trials. These considerations are informed by Site Advocacy Group discussions as well as a cross-consortia Diversity Roundtable Event about how to sustainably partner with sites to enable greater diversity in clinical trials. |
|
|
Tools to Help You Celebrate Clinical Trials Day |
Association of Clinical Research Professionals (ACRP) |
|
|
The Importance of Diversity in Clinical Trials (Video) MT Pharmacy (Video) Finding Treatments Together Brochures and Videos:
|
Information about clinical research and how it can impact you, your family, and your community. |
Center For Information and Study on Clinical Research Participation (CISCRP) |
|
An educational program that partners with organizations to bring accessible clinical research information to the public. Features free health screenings, an informational exhibit booth, and a panel discussion of healthcare professionals, physicians, patients, caregiver speakers and more. |
||
|
The mission of the Coalition for Clinical Trials Awareness is to advocate for the creation of a federally sponsored public awareness campaign to increase the public’s understanding of the benefits of clinical trials. |
Coalition for Clinical Trials Awareness |
|
|
Leveraging Social Media to Raise Awareness and Build Community |
Social media specialists Joseph M. Coe, MPA, from the PCORnet® Patient-Powered Research Network (PPRN) ArthritisPower (formerly AR-PoWER) and M. Patricia McAdams, MS, from the PCORnet Coordinating Center explore the opportunities and obstacles for leveraging social media in a network, including best practices and case studies to enhance understanding. This information can be used by numerous stakeholders to better understand how to use metrics to inform channel strategy and how collaborations and partnerships can help reach more people. |
Patient-Centered Outcomes Research Institute (PCORI) |
|
The path from understanding a disease to treating it with medicines is long, difficult, and expensive. Learn about the clinical trials process — which entails rigorous research studies and human volunteers — that helps ensure that medicines are safe and effective for the patients that use them. |
Pharmaceutical Research and Manufacturers of America (PhRMA) |
|
|
Biopharmaceutical research and clinical trials are taking place across the U.S. every day. Explore the interactive map and select a state to access data on biopharmaceutical jobs, the industry’s overall economic impact, clinical trial activity and more. |
||
|
The Trusted Source for Clinical Trials Information |
WCG CenterWatch |
Pre-Trial
Provide Education
Consider providing educational materials and solutions to facilitate participation in clinical trials
Opportunity
Information about clinical trials has become increasingly complex, technical, and more difficult for potential participants to understand and locate. Providing clear and easy to understand general information about clinical trials and providing solutions to facilitate participation allows patients to more easily find clinical trials and be better informed when making the decision to participate.
Considerations to Help Action the Opportunity
- Identify a communication strategy / plan (e.g., what information should be shared, how, when, to whom)
- Provide “health literacy” expertise to clinical trial information
- Try to align the timing of distribution of materials to participant preference
- Better accommodate participant preferences by making materials available in various formats (e.g., paper, online)
- Identify types of content and format (e.g., videos, graphics, illustrations, etc.) to make clinical trial related information more accessible, particularly to those who are non-native English speakers or those who may have learning disabilities
- Offer detailed, patient-friendly information to better allow patients to review in their own time
- Identify what materials may be needed in local language and timing of ethics committee reviews
- Consider developing a sponsor website (global trial database) that allows clinical trial participants to search for all available clinical trials available to them (e.g., search by indication, etc.)
- Promote your global website is implemented (e.g., “get the word out” via Google Ad paid search, or through patient advocacy groups and community leader websites)
- Provide links to other sponsor trials in the same indication so the patient’s search journey continues
- Partner with patients to build tools and resources tailored to the indication (i.e., study-specific websites), which may include study information, and is linked to a global clinical trial database (i.e., sponsor-specific or clinicaltrials.gov) for consistency
- Partner with patient organizations, community leaders and social media, if possible, to extend the reach of the study-specific website
Value and Potential Benefits
- Empowers patients with information to help make informed decisions about clinical trial participation
- Increases transparency and access to clinical trial information for participants to better support informed decision making
- Improves patient experience, as they can choose the learning style that suits them to assist in understanding of trial information and their rights / options when participating in a clinical trial
- Improves recruitment and retention as well-informed patients tend to create more reliable trial participants
- Increases awareness with targeted information (i.e., provide in-language information)
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
The Operational Complexity Assessment Tool is an interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. |
TransCelerate BioPharma, Inc. |
|
|
The Process Frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions. It is important to note that whether and to what extent a solution may be deemed patient-centric will vary depending on the particular circumstances. Only by considering patient needs, preferences, and other factors, can a sponsor decide what the right approach is for a particular trial. |
||
|
The eConsent Initiative team has collaborated with patient and site advocates, Health Authorities and institutional review boards (IRBs) / independent ethics committees (IECs) to develop the following assets:
|
||
|
Paper offers guidance on a practical first step toward closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings. |
||
|
Graphic showcases patient reported data around the process of searching for clinical trials and what information they are expecting prior, during and after participating in a clinical trial. |
||
|
Narrated video describes the purpose of the Clinical Trial Registration Tool and how to use it. |
||
|
The Clinical Trial Registration Tool is a tool individual clinical trial sponsors can use to proactively evaluate the quality of the clinical trial registration data they submit to government-owned registries. Download to take a closer look at how you may be able to leverage the Clinical Trial Registration Tool. |
||
|
What Patients Want to See in Clinical Trial Registries Infographic |
Infographic highlights key findings for patient preferences when searching for available clinical trials. |
|
|
The paper describes the results of a global survey on the information preferences of patients when looking for a trial to participate in. It also provides an analysis of current ClinicalTrials.gov entries in regard to their patient friendliness and their adherence to guidelines. The paper concludes that sponsors should make ClinicalTrials.gov entries more user friendly to facilitate patient access to clinical studies. |
||
|
Narrated video describes the purpose of the Clinical Trial Registry of the Future concept and the principles of its design. |
||
|
Narrated video highlights new ways patients might search for and narrow down clinical trial options, as demonstrated in the Clinical Trial Registry of the Future concept. |
||
|
Narrated video highlights information and features proposed in the Clinical Trial Registry of the Future concept aimed at providing patients a more robust experience when evaluating or considering a clinical trial. |
||
|
Improving the Value of Public Clinical Trial Registries to Patients: A Perspective and Call to Action |
Proposal illustrates the challenges patients, their family members and healthcare professionals face when interacting and understanding the vast clinical research information available through government-sponsored registries, and provides a perspective, illustrative proof of concept, and call to action to advance multi-stakeholder collaboration on potential improvements to clinical trial registries. |
|
|
eBook illustrates the step-by-step user experience and functions featured on each screen in the Clinical Trial Registry of the Future proof of concept. |
||
|
ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT Data Flow Maps; and (5) a Change Management Question-and-Answer resource. |
The Association of Clinical Research Organizations (ACRO) |
|
|
Brochures, videos, medical hero stories, and more that help industry stakeholders and the public be more informed about clinical research. |
Center For Information and Study on Clinical Research Participation (CISCRP) |
|
|
The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. |
Decentralized Trials and Research Alliance (DTRA) |
|
|
Resources for the public to learn about participating in research and making informed decisions. |
Food & Drug Administration (FDA) |
|
|
Provides information and links for health literacy tools and resources, including:
|
Multi-Regional Clinical Trials (MRCT) |
|
|
This glossary is a list of research words and their meanings. Use this glossary to learn more about words that are used in research studies. |
Pre-Trial
Co-Create Design & Delivery
Consider including patient / care partner input in the study design and delivery
Opportunity
Patients are experts in their condition and should inform clinical development. Patient / care partner input early on during the study design and protocol development can help improve patient experience in clinical trials, reduce patient burden, and increase recruitment, retention, and enrollment rates.
Considerations to Help Action the Opportunity
- Define internal sponsor processes to support patient / care partner engagement early in drug development, including budgetary requirements, contracts, IRB / ethics review, legal and data privacy issues, etc.
- Develop an engagement strategy early in the drug development process outlining the plan for identification of representative samples of patients, engagement method(s), timing of engagement(s), data utilization, sharing, assessment, etc.
- Understand investigator / clinical site perspective (in addition to patient / care partner input) of processes, investments and working practices
- Develop robust communication strategy to share information back to patients / care partners about how feedback influenced protocol design / other study elements and justification for when it was not used
- Understand patients / care partners input on the operational difficulties and the options for patients / care partners that can be included in trial design to overcome these
- Establish early partnerships among patients, sponsors, and investigators / clinical sites to build commitment for ongoing sharing of information
Value and Potential Benefits
- Improves patients’ clinical trial experience, reduces patient burden, and increases enrollment rates through patient-centric study design
- Establishes early connection between patients / participants and clinical development program, product / brand and company
- Improves the representation of diverse patient populations in clinical trials via tailored solutions and focused investments
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
Comprehensive set of materials that sponsors and other stakeholders can use to engage patients and caregivers during protocol development. |
TransCelerate BioPharma, Inc. |
|
|
Infographic: Toolkits to Help Amplify The Patient Voice in Clinical Research |
An infographic highlighting:
|
|
|
Manuscript that highlights the rationale for development of the Patient Protocol Engagement Template (P-PET) and Study Participant Feedback Questionnaire (SPFQ) to incorporate the patient perspective into development and execution of clinical trials. |
||
|
Engaging patients as partners to obtain meaningful insights on clinical research |
A variety of tools and methods designed to engage patients and care partners and obtain meaningful insights to help inform protocol designs and operational strategies. |
Center For Information and Study on Clinical Research Participation (CISCRP) |
|
Patient involvement in the development, regulation and safe use of medicines |
This report describes the importance of systematically involving patients throughout a medicine’s life – from its early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. |
Council for International Organizations of Medical Sciences (CIOMS) XI |
|
Incorporating perspectives from patients and patient organization leads to more meaningful clinical trials with increased feasibility, enhanced recruitment and retention, and real-world outcomes. CTTI’s work helps you ensure patients are engaged as partners early and often in your research process. |
Clinical Trials Transformation Initiative (CTTI) |
|
|
Avoiding errors, collecting data that is fit-for-purpose, and reducing patient burden are just a few of the many benefits of applying Quality by Design (QbD)—an approach that focuses resources on the errors that matter to decision making during a trial. CTTI has built a suite of resources (including recommendations for monitoring and QbD, a principles document and a QbD toolkit) to help organizations and individual trial teams effectively implement a QbD approach to their trials. |
||
|
FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making |
A series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making. |
Food & Drug Administration (FDA) |
|
This toolbox centralizes all PARADIGM’s co-created recommendations, tools and relevant background information to make patient engagement in medicines development easier for all. |
Innovative Medicines Initiative (IMI) PARADIGM |
|
|
The “Including Young People in Research” toolkit offers tools, checklists, and considerations to support the intentional inclusion of the youth perspective in pediatric clinical trials and product development. These materials can assist investigators, Institutional Review Boards (IRBs) / Ethics Committees (ECs), sponsors, and others working with children and adolescents to engage youth respectfully and thoughtfully, helping to ensure that their perspectives are valued, gathered, appropriately weighted, and integrated. |
Multi-Regional Clinical Trials (MRCT) |
|
|
Your global hub for practical tools to plan, assess and execute any patient engagement initiative. |
Patient-Focused Medicines Development (PFMD) |
During Trial
Involve Health Care Provider
Consider involving the participant’s personal doctor throughout the clinical trial process to support management of care
Opportunity
Build a continuity of care in the participant’s medical journey by involving the participant’s personal doctor in clinical trials. This may help to reduce the participant’s burden by avoiding duplication between standard of care / trial assessments and allowing clinical trial assessments to be completed locally.
Considerations to Help Action the Opportunity
- Clarify roles and responsibilities, in line with Good Clinical Practice (GCP) (e.g., that the investigative site retains responsibility for determining if events are adverse event(s) and making treatment decisions based on personal doctor data)
- Define agreements required between investigative site, personal doctor, and sponsor (as appropriate)
- Define procedures / tools to share participant’s data between site, personal doctor, and sponsor in line with data privacy requirements
- List requirements of the personal doctor to perform trial assessments (e.g., trial specific training, delegation, safety reporting, indemnity insurance, financial indemnity, documentation such as FDA 1572, etc.)
- Partner with participants to understand their acceptance and comfort having trial assessments performed by their personal doctor
- Partner with investigative sites to ensure they can manage the requirements of working with a personal doctor and can support appropriate oversight
- Partner with personal doctor as needed for trial specific requirements (e.g., training, agreements, financial considerations, etc.)
- Understand varying levels of engagement desired by personal doctors (e.g., awareness vs. active involvement) along with engagement mapping
- Define how to empower clinical trial participants to relay appropriate information with their personal doctor including both test results with contextual ranges that could vary from standard of care
Value and Potential Benefits
- Reduces duplication of effort between trial assessments and what a participant’s personal doctor would perform as part of the standard of care
- Allows participant to have assessments performed in their usual care setting and by a personal doctor known to, and trusted, by them
- Saves the participant time and effort by reducing visits to investigative site
- Enables the personal doctor or specialized healthcare provider to treat the participant with a holistic view of their trial and non-trial needs
- Allows continuity of care delivered before, during, and after the trial
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
Building Bridges Between Health Care Providers (HCPs) and Clinical Research |
The first step toward involving patient’s HCPs in the trial process, is engaging HCPs in the first place. This brochure highlights the critical role that HCPs have in patient trial participation as trusted resources and provides clear actions for both HCPs and clinical research professionals to bridge the gap. |
Center For Information and Study on Clinical Research Participation (CISCRP) |
|
Currently, the clinical trial enterprise functions largely independently from the clinical practice setting. Embedding trial elements into clinical practice can enable evidence-based quality care and reduce clinical trial inefficiencies. While we can learn from and repurpose examples of embedded interventional trials, as a united health care front we need to work together to drive change and reduce cultural, administrative, financial, and data-related barriers. To accomplish this, CTTI carried out qualitative, in-depth interviews with sponsors and with those conducting interventional clinical trials that are embedded into clinical practice and gathered input from a multi-stakeholder project team and Expert Meeting. The output was a set of recommendations to facilitate the integration of randomized, interventional trial elements into clinical care. |
Clinical Trials Transformation Initiative (CTTI) |
|
|
A template for obtaining permission to contact a participant’s healthcare provider or doctor about individual research results, along with their contact information. |
Multi-Regional Clinical Trials (MRCT) |
During Trial
Collect Digital Data
Consider selection of the device used to collect study information
Opportunity
Participants expect a simple and convenient experience participating on clinical trials. To accomplish this goal, sponsors should consider the type, design and delivery of device (e.g., personal device, provided by study, etc.) for participants to achieve accessibility, flexibility, convenience and maintain privacy.
Considerations to Help Action the Opportunity
- Understand if the clinical trial design supports the applications of digital patient solutions
- Understand the needs and preferences of the participants taking part in the trial
- Does the population have access to devices and data plans, or would they need these to be provisioned?
- What devices would participants already have that could be used for clinical trials (e.g., wearables / sensors, glucometers, weighing scales, phones / tablets, etc.)?
- Understand impact on health equity (i.e., geographic, socioeconomic barriers) when implementing digital solutions
- Partner with sites to gain their input on the impact of multiple services, training, and technology implementation
- Understand how the device may impact data integrity, regulatory landscape, site implementation and overall costs
- Define how technology is designed, communicated and delivered for / to participants
- Define backup options (e.g., when a participant is unable to connect to device)
Value and Potential Benefits
- Increases access and ease of participation for participants on clinical trials by potentially reducing the number of site visits
- Allows for more robust datasets with improved data compliance and quality by enabling direct entry and near real-time review of data
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
The Operational Complexity Assessment Tool is an interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. |
TransCelerate BioPharma Inc. |
|
|
The Process Frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions. It is important to note that whether and to what extent a solution may be deemed patient-centric will vary depending on the particular circumstances. Only by considering patient needs, preferences, and other factors, can a sponsor decide what the right approach is for a particular trial. |
||
|
The Patient Technology Toolkit was designed to help decision-makers and study teams approach PT implementation strategically with long-term goals and scalability in mind, facilitate the flow of knowledge and feedback between internal and external clinical trial stakeholders with respect to PT, and help study teams identify, prevent or mitigate potential risks associated with PT adoption. It includes an Implementation Framework, the PT Discussion Guide, Patient Considerations, Regulatory Landscape Tool, PT Site Feedback Questionnaire, and Vendor Engagement and Vendor-Influenced Tools. |
||
|
This manuscript describes the potential for patient-facing digital technologies (also called “Patient Technology”) to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools. To understand the barriers and facilitators affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts (SMEs), including pharmaceutical company representatives, clinical trial investigators, and clinical trial participants. We identified several challenges that were common across the industry and outlined several recommendations to address them. |
||
|
The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). |
||
|
Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach |
Our presenters will follow Digital Medicine Society’s (DiMe) V3 framework and Clinical Trials Transformation Initiative’s (CTTI) framework in a hypothetical case to validate a sleep endpoint. We will identify key considerations and challenges and describe approaches for developing novel digital endpoints for use in medical product development. Additionally, we will highlight the importance of regulatory strategy in the development and validation of novel digital endpoints. At the end of the webinar, there will be an opportunity for Q&A with our speakers and additional panelists Lindsay Kehoe from CTTI and Jennifer Goldsack from DiMe. |
|
|
ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT Data Flow Maps; and (5) a Change Management Question-and-Answer resource. |
The Association of Clinical Research Organizations (ACRO) |
|
|
A collection of recommendations and resources that have been created by multi-stakeholder teams. |
Clinical Trials Transformation Initiative (CTTI) |
|
|
The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. |
Decentralized Trials and Research Alliance (DTRA) |
|
|
This article describes the process of documenting a clinical trial, including:
|
The European Patients’ Academy (EUPATI) |
During Trial
Deliver Direct-to-Participant
Consider how / where study medication is received
Opportunity
It is important to consider how study participants receive their study medication, to minimize impact to their time / effort and to align with a move towards decentralization of clinical trials. The provision of study medication could be achieved through direct-to-participant (otherwise known as direct-to-patient (DtP)) shipping, which includes depot-to-patient, pharmacy-to-patient, clinical site-to-patient, or by shipping to a local pharmacy or clinic for collection.
Considerations to Help Action the Opportunity
- Understand patients’ preference and capabilities for receipt of study medication (i.e., shipment to home vs collection from local clinic / pharmacy)
- Develop training and documentation to facilitate participant / care partner(s) use and confident compliance; emphasize site contacts or other contacts for questions or support
- Understand whether the study medication is appropriate for at home administration / storage; detailed risk assessment may be appropriate
- Understand the distribution models in each country to manage the full chain of custody that satisfies regulatory and privacy requirements, given that these requirements for DtP are generally country-specific
- Partner with sites to support acceptance of study medication transport from site pharmacy, or depot, and according to site processes
- Understand site challenges / concerns associated with third-party and participant oversight and their ability to maintain study drug oversight
- Understand the requirements of the site pharmacy, depot or local clinic / pharmacy to prepare study medication for transport, at home storage and use
- Define appropriate storage facilities and controls to maintain stability, prevent temperature excursions or unauthorized use at participants’ home
- Define how unused medication will be returned and the systems and processes needed to manage accountability and compliance (e.g., IXRS, EDC)
- Develop medication compliance measures to accommodate for the change in oversight
- Partner with vendors to cover critical services needed to address study medication stability and confirmation of delivery to participant is obtained
- Evaluate shipping vendors qualifications for study medicine shipment, as per local requirements for dispensing and cross-border / state transport
Value and Potential Benefits
- Helps to improve patient recruitment and retention by reducing the number of in clinic visits (e.g., to collect and / or re-supply study medication) and subsequent impact on participants daily life, potentially leading to increased participant interest to join a clinical trial
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
The Operational Complexity Assessment Tool is an interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. |
TransCelerate BioPharma, Inc. |
|
|
The Process Frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions. It is important to note that whether and to what extent a solution may be deemed patient-centric will vary depending on the circumstances. Only by considering patient needs, preferences, and other factors, can a sponsor decide what the right approach is for a particular trial. |
||
|
ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT Data Flow Maps; and (5) a Change Management Question-and-Answer resource. |
The Association of Clinical Research Organizations (ACRO) |
|
|
CTTI provides considerations for assessing the landscape and delivering an intervention to trial participants in line with federal and state telemedicine laws, as well as regulations related to a product’s registration status with the FDA |
Clinical Trials Transformation Initiative (CTTI) |
|
|
Regardless of where your trial is on the decentralized spectrum, CTTI’s recommendations can help you plan and conduct a successful trial. This site also includes links to Resources and Related Items. |
||
|
The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. |
Decentralized Trials and Research Alliance (DTRA) |
|
|
Recommendation paper on decentralised elements in clinical trials |
The recommendation paper from the Heads of Medicines Agency (HMA) and the European Medicines Agency (EMA) on the topic of Decentralized Clinical Trials covers topics including delivery of study medications to participants. It also includes the National Provisions Overview annex, which describes what DCT elements are accepted in each EU Member State. |
Heads of Medicines Agency (HMA), European Medicines Agency (EMA), European Commission |
|
SCRS and the multi-stakeholder Digital Innovation Initiative – Decentralized Trials Workstream team created this document to create a simpler and more streamlined user experience. The intent of this publication is to serve as a reference as sites begin to operate hybrid decentralized trials so they can most efficiently assess their own capabilities and gaps. |
Society for Clinical Research Sites (SCRS) |
|
|
The Trials@Home consortium explores the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralized Clinical Trials (DCTs) make use of new, digital innovations and enable participants to visit a clinical trial center less frequently, if at all. |
Trials@Home |
During Trial
Offer Scheduling Methods
Consider Selection of Scheduling Methods
Opportunity
Participants expect some flexibility and do not want clinical trial participation to significantly impact their normal daily schedule. Sponsors should consider exploring solutions that allow participants to more easily find and select times for appointments, especially with increased flexibility and more diverse procedure locations.
Considerations to Help Action the Opportunity
- Understand the individual needs of each participant and their preferences
- Partner with sites to build flexibility into the clinical trial design by providing timing and location options for visits
- Explore decentralized clinical trial options, such as telemedicine and the use of local clinics and sites
Value and Potential Benefits
- Increases flexibility and ease of scheduling
- Encourages patient engagement and empowers patients
- Reduces the barriers to finding and attending appointments potentially leading to better compliance and retention
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
This guide explains the goal of using patient scheduling to maximize the productivity and utilization rates of the clinicians, doctors, and staff. |
Business News Daily |
|
|
In this article, you’ll see ten of the best practices to increase productivity and improve patient experience and satisfaction. |
Medical Device News Magazine |
During Trial
Offer Location of Procedures
Consider the location of procedures
Opportunity
Flexibility to choose the location for clinical trial procedures (i.e., onsite or offsite [e.g., at home, local clinic, etc.]) can reduce burden on clinical trial participants in terms of travel requirements. Reducing the need to travel to the site for all visits can have a positive impact on recruitment and retention (e.g., giving flexibility around work, childcare, etc.), facilitating participation by individuals located further from clinical sites.
Considerations to Help Action the Opportunity
- Understand conditions that are required for trial conduct and how best to implement them at offsite location(s) to maximize flexibility of participation by utilizing telehealth visits, home nursing, local facilities, mobile clinics, pharmacies, satellite sites, etc.
- Define how study assessments can be performed with the consistency to clinical trial standard, such as:
- Processes to implement protocol (e.g., teach-back technique, real-time monitoring of assessment completion, etc.)
- Safeguards to help confirm that equipment will work correctly (e.g., calibrated equipment, internet access, back-up options, etc.)
- Access to resources in case of emergencies or to help maintain participant safety (e.g., home nurse training, emergency medication, proximity to emergency care facilities, etc.)
- Understand that some visits can be onsite if required, for example, if IMP stability / preparation requirements do not allow for home administration or a physician needs to physically see the participant
- Understand the amount of time procedures take and associated travel time to and from clinics (e.g., travel time could be reduced by offering local lab visits and / or remote visits)
- Partner with investigative sites to leverage their own resources and processes, as applicable, to facilitate offsite visits, and to understand and mitigate challenges / concerns associated with third-party, such as:
- PI accountability and oversight
- Plan for alternative / backup in case of required / requested changes (e.g., independent providers that carry out procedures who are not directly controlled by the sponsor or investigative site including PI oversight) and participant oversight
- Define data delivery plan / map to support compilation of data from various locations / care delivery settings
Value and Potential Benefits
- Brings the clinical trial closer to participants that live far away from the clinic or when clinic visits are logistically complicated to arrange based on personal circumstances (e.g., patient mobility, desire to travel)
- Increases convenience to participate by accommodating various options for the delivery of care
- Allows for flexibility for site staff (e.g., focus on difficult visits vs. simple blood draws) to utilize their time more efficiently and potentially reduces the need for additional operating hours (e.g., weekend and evening visits)
- Potentially allows sites to conduct more clinical trials (e.g., less on-site visits may result in more availability to run trials)
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
The Operational Complexity Assessment Tool is an interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. |
TransCelerate BioPharma, Inc. |
|
|
Home Health Visits Process Framework |
The Process Frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions. It is important to note that whether and to what extent a solution may be deemed patient-centric will vary depending on the particular circumstances. Only by considering patient needs, preferences, and other factors, can a sponsor decide what the right approach is for a particular trial. |
|
|
ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT Data Flow Maps; and (5) a Change Management Question-and-Answer resource. |
Association of Clinical Research Organizations (ACRO) |
|
|
The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. |
Decentralized Trials and Research Alliance (DTRA) |
During Trial
Provide Support Services
Consider incorporating support services that reduce barriers and enable better access for clinical trial participation
Opportunity
Access to clinical trials may be limited depending upon the participant’s circumstance. Providing support services (e.g., transportation assistance) may help to eliminate logistical barriers to participation.
Considerations to Help Action the Opportunity
- Incorporate input from participants, care partners and sites to proactively develop a plan to implement support services
- Partner with investigative sites to understand if support service(s) is suitable for the clinical setting and their participants
- Define reimbursement options, including how and what to reimburse, tailoring services to the sites’ and patients’ needs, such as:
- Accessibility supports
- Transportation assistance
- Accommodation assistance
- Care of dependents
- Food
- Out-of-pocket
- Consider how to provide reimbursement in a timely manner
- Identify a single point-of-contact for participant coordination on all relevant support services, including navigating insurance where applicable
- Consider extending hours of operation for participants to attend in evenings or weekends
- Understand the timing of assessments to help minimize participant burden, such as reducing the need to fast all day and facilitating out-of-hours collections or windows for collection (e.g., lab samples testing over the weekend or an allowance that these can be stored over the weekend to facilitate collection of samples on a Friday)
Value and Potential Benefits
- Allows greater access to clinical trials and helps further support patients to remain enrolled
- Maximizes flexibility in the type of study visits available for participant with less logistic burden
- Increases convenience to participate regardless of participant’s life circumstances (e.g., barriers to trial participation due to health status, financial background, logistical burdens, mental blockades, and insecurities)
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT)
|
The Site Engagement and Capacity Building Considerations supports efforts to facilitate meaningful inclusion of diverse patient populations in clinical trials. These considerations are informed by Site Advocacy Group discussions as well as a cross-consortia Diversity Roundtable Event about how to sustainably partner with sites to enable greater diversity in clinical trials. |
TransCelerate BioPharma, Inc. |
|
An IRB Resource for Investigators, Practical Points to Consider: Payment to Research Participants |
This guidance document provides an overview of types of payments, considerations for each type of payment, and why payment to participants can be a barrier to participation in clinical trials. |
Multi-Regional Clinical Trials (MRCT) |
|
Accessibility by Design: A Toolkit for Inclusion of People with Disabilities in Clinical Research |
This Toolkit provides considerations on communication and physical accessibilities, general considerations, and strategies of inclusion for participants with disabilities. |
During Trial, Post-Trial
Provide Point-of-Contact
Consider providing the ability to request support for any reason during or after the clinical trial
Opportunity
Clinical trial participants may have many questions and concerns during and after the clinical trial. To help address participants’ questions / concerns in a timely manner, support (e.g., phone number to call, in-app support, virtual bot) can allow clinical trial participants to receive answers and reassurance without needing to wait for the next scheduled visit.
Considerations to Help Action the Opportunity
- Partner with investigative sites to ensure understanding of currently available site contact support and what support sites may need to enable flexibility
- Identify multiple options for a participant to contact / stay engaged with the investigative site or reach out to a designated contact
- Provide a clear description of which service should be used in each situation and point of contact, if several service options are available
- Offer service(s) in the participant’s native language and make them available 24/7
- Partner with participants / patient organizations to ensure support services are easy to use and fit their needs
- Provide tools and training to enable participant self service
Value and Potential Benefits
- Allows participants to ask questions regarding clinical trial participation when needed, potentially alleviating concerns at the current time rather than waiting for next visit
- May increase participant engagement by allowing stronger connectivity between participants and clinical trial staff
Tools and Resources
- No tools or resources currently available to support this opportunity
During Trial
Enable Communication
Consider method and frequency of participant communication during the clinical trial
Opportunity
Clinical trial participants will likely not feel engaged with the clinical trial if they are not informed about what matters to them (e.g., trial progress) at an appropriate frequency. Providing relevant information through a method that meets their needs and preferences could improve participant engagement, compliance and retention. Value can be gained where participants can choose how and when they receive communications.
Considerations to Help Action the Opportunity
- Partner with patient organizations and sites to identify the types of information that participants would like (e.g., gratitude, trial progress) and the preferred method and frequency for sharing of information
- Define the settings (e.g., in-person or self-reviewed), mediums (e.g., written, audio or visual), delivery methods (e.g., paper, email, WhatsApp / text, portal / app), preferred language, and frequency (e.g., weekly, monthly, annually) for the communications
- Utilize the settings, mediums and methods that work for the participant population and ideally provide multiple options to suit the spectrum of participant needs (e.g., to account for country or age preferences)
- Define design considerations that factor in the participant or site needs, such as font sizes, consistent formatting and ‘branding’
- Develop a participant communication plan that captures participant preferences and delivers communications accordingly
- Define the timing and requirements of obtaining Ethics Committee (EC) approval (e.g., submit any templates at the start of the study outlining the type of communication planned) on participant facing materials and the method of delivery
Value and Potential Benefits
- Increases understanding and engagement in the trial if participants receive communications that are relevant to them in a preferred format and frequency
- Allows participants to have the information they require, while avoiding overwhelming or burdensome communications
- Allows participants to feel appreciated and valued for their involvement in the study
- Potentially increases trial participant retention (avoid drop-outs) and compliance (higher motivation)
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
Infographic highlights potential communication opportunities to provide the information patients are looking for along the clinical trial continuum. |
TransCelerate BioPharma, Inc. |
|
|
Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry |
This paper reviews data collected by TransCelerate around information exchange in clinical trials, including insights from patients, sponsors, sites and healthcare professionals, and provides potential opportunities to improve participants’ experience with clinical trials through greater transparency. |
|
|
A survey provided to study participants at the beginning, middle and end of a clinical study. |
||
|
A set of deliverables that sponsors, with their site partners, can leverage to acknowledge and show appreciation to clinical trial participants. |
||
|
Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he / she has enrolled in a clinical study. |
||
|
Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he / she has completed participation in a clinical study. |
||
|
Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after the full clinical study is completed and results of the study are available. |
||
|
Layperson Summaries of Clinical Trials: An Implementation Guide |
Provides general principles helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation (EU CTR) No 536/2014. |
|
|
Recommendations for Drafting Non-Promotional Lay Summaries of Clinical Trial Results, as referenced in the Layperson Summaries in Clinical Trials: An Implementation Guide |
Intended to provide general principles to help sponsors prepare lay summaries in a manner that reduces the risk that the summaries could be perceived as promotional, which would raise regulatory concerns. |
|
|
Provides guidance to consider when developing an educational slide set on the overview of layperson summaries, potential content for the layperson summary, and investigator involvement. |
||
|
Provides a sample Thank You Letter to thank participants for taking part in the study and provides information on how, when, and where the results and / or layperson summaries will be made available to participants. |
||
|
Provides guidance when discussing the results of the study with the participants and answering study participants’ questions in a non-promotional manner. |
||
|
Provides a sample letter which may be used to communicate with investigators and site personnel about the plans of providing layperson summaries. |
||
|
Provides a sample communication deck which describes the vision and overview of the layperson summary program. |
||
|
Informed Consent Forms – Health Communication Services (ciscrp.org) What is Informed Consent? eConsent? – Clinical Research Videos (ciscrp.org) |
Improving ICF templates to create patient-friendly, study specific ICFs coupled with the use of video assists potential participants in better understanding the clinical trial they are considering. |
Center For Information Study on Clinical Research Participation (CISCRP) |
|
Trial Participant Communications – Health Communication Services (ciscrp.org) |
Ongoing communication cards keep current participants engaged throughout the process. |
|
|
Considerations for Optimizing Digital Clinical Trials by Engaging Patients and Sites |
Considerations for optimizing digital technologies to support communication with participants during design and conduct of clinical trials. |
Clinical Trials Transformation Initiative (CTTI) |
During Trial, Post-Trial
Express Gratitude
Consider implementing acknowledgement or gratitude to participants and their care partners
Opportunity
Clinical trial participants and their care partners often do not feel valued for their contribution to clinical trials, which may impact retention, participant satisfaction, and overall adherence. Receiving an act of appreciation (e.g., a thank you card / letter) during a clinical trial is directly related to overall satisfaction with the clinical trial.
Considerations to Help Action the Opportunity
- Include decisions around gratitude as part of the engagement strategy early in the clinical development planning process
- Understand which tools and templates are most appropriate to your study and patient population
- Test gratitude tools with the patient population
- Define distribution methods and understand how use of decentralized trials / platforms may impact which format is used
- Identify opportunities to evaluate the value of the tactics and how they were received by participants / care partners (e.g., incorporating questions regarding gratitude into the SPFQ or similar patient feedback questionnaire)
Value and Potential Benefits
- Improves recruitment from word-of-mouth referrals by participants speaking positively about their experience in clinical trials
- Improves engagement, adherence, and compliance by recognizing the time and effort participants contribute to the clinical trial
- Increases participant’s satisfaction and perceived value of their clinical trial journey by recognizing the value of their experience
- Improves relationships with clinical research staff by recognizing the important relationship they develop with the patient and work needed to make the trial successful at their site
- Improves industry reputation and trust in clinical research
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
A set of deliverables that sponsors, with their site partners, can leverage to acknowledge and show appreciation to clinical trial participants. |
TransCelerate BioPharma, Inc. |
|
|
Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he / she has enrolled in a clinical study. |
||
|
Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he / she has completed participation in a clinical study. |
||
|
Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after the full clinical study is completed and results of the study are available. |
||
|
Trial Participant Communications – Health Communication Services (ciscrp.org) |
Develop and deliver thank you cards to study volunteers via the research site. |
Center For Information and Study on Clinical Research Participation (CISCRP) |
|
These resources are provided to help with developing thank you’s for clinical trial participants |
Clinical Trials Ontario |
|
|
Pediatric Trials Network: Stakeholder views on thanking families and providing study findings on pragmatic pediatric clinical research |
An article outlining formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric studies conducted by the National Institute of Health-sponsored Pediatric Trials Network. |
Contemporary Clinical Trials Communications |
|
Article which highlights the importance of thanking participants in clinical trials |
Nature |
|
|
How Showing Appreciation for Past Clinical Trial Patients Can Help to Recruit New Ones |
Article highlighting an initiative undertaken by pharmaceutical company Eli Lilly shows the importance of saying, “Thank You,” to clinical trial patients. |
Patient Centra |
During Trial, Post-Trial
Return Participant Data
Consider returning data to clinical trial participants
Opportunity
Clinical trial participants would like more data returned to them during and after participation in clinical trials; however, the frequency, timing and type of data returned to participants today is varied and inconsistent. This opportunity provides participants with the option of receiving their study data / results in the format and at the time they choose.
Considerations to Help Action the Opportunity
- Address individual participant data return issues early in the clinical development planning process
- Ensure security of participant privacy, confidentiality, flexibility and safety while maintaining scientific integrity and product approval timelines
- Prioritize and personalize optionality in delivery and content as best as possible
- Provide support to sites, HCPs, participants and their care partners regarding management of individual data to optimize access, inclusiveness and health equity
- Understand how digital technologies and existing cross collaborations can be optimized to facilitate interoperability of systems which collect and manage patient / participant clinical care and clinical research data
Value and Potential Benefits
- Demonstrates respect and gratitude for the participant’s contributions to scientific advancements in research and development
- Enhances patient partnerships and autonomy
- Informs patients and increases awareness about clinical trials and enhances public trust, fairness and transparency
- Improves clinical trial engagement and the participant experience, potentially facilitating recruitment and retention
- Utilizes a proactive approach to achieve operational efficiencies by being prepared for unplanned requests for individual data
- Empowers participants to be more active decision makers when it comes to the use of the data they contribute to improve health outcomes
- Reduces the burden on participants and health systems by reducing repeated testing / exams, where possible
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
The Individual Participant Data Return Package provides general considerations to enable data return to clinical study participants and includes three components – a Socialization Presentation, Considerations Guide, and Template. |
TransCelerate BioPharma, Inc |
|
|
A consolidated set of resources from within the clinical research ecosystem that can assist sponsors with returning individual data globally. These resources can be utilized by sponsors to rationalize and / or initiate efforts focused on enabling participant data return, as they provide foundational information to get started. This resource pack includes available solutions from MRCT, NIH, IMI FACILITATE, and others. |
||
|
Provides a sample Thank You Letter to thank participants for taking part in the study and provides information on how, when, and where the results and / or layperson summaries will be made available to participants. |
||
|
Provides guidance when discussing the results of the study with the participants and answering study participants’ questions in a non-promotional manner. |
||
|
Provides a sample letter which may be used to communicate with investigators and site personnel about the plans of providing layperson summaries. |
||
|
Provides a sample communication deck which describes the vision and overview of the layperson summary program. |
||
|
Layperson Summaries of Clinical Trials: An Implementation Guide |
Provides general principles helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation (EU CTR) No 536/2014. |
|
|
Recommendations for Drafting Non-Promotional Lay Summaries of Clinical Trial Results, as referenced in the Layperson Summaries in Clinical Trials: An Implementation Guide |
Intended to provide general principles to help sponsors prepare lay summaries in a manner that reduces the risk that the summaries could be perceived as promotional, which would raise regulatory concerns. |
|
|
Provides guidance to consider when developing an educational slide set on the overview of layperson summaries, potential content for the layperson summary, and investigator involvement. |
||
|
Unblinding Communications – Health Literacy & Communications (ciscrp.org) |
A tool to return individual treatment assignments to trial participants. |
Center For Information and Study on Clinical Research Participation (CISCRP) |
|
A tool to return aggregate trial results to trial participants. |
During Trial, Post-Trial
Seek Feedback
Consider creating opportunities to gather in clinical trial participant feedback that generate actionable insights
Opportunity
The experience of patients participating in clinical trials may not consistently meet expectations. Poor participant experience is a negative influencer of recruitment, retention, and reputation. Therefore, it is important to provide clinical trial participants with the opportunity to provide feedback on various aspects of the study (including the study information, assessments, visit type / schedule, devices, the site and impact on their time) to improve participant experience on current and future studies.
Considerations to Help Action the Opportunity
- Define the factors that impact patient experience during a trial. Factors may include quality of care (e.g., treatment, inclusion / exclusion criteria), ease and convenience (e.g., site / location, travel, reimbursement), connection and human touch (e.g., communication, information, site staff)
- Understand which tools can be utilized to collect participant feedback and measure these patient experience factors. This could include both qualitative methods, like in trial or exit interview, or quantitative participant feedback questionnaires (e.g., optional surveys) administered at different timepoints on the study. Understand whether these tools cover all countries of interest (where the sponsor is allowed to operate)
- Utilize standardized participant feedback tactics to help elicit actionable participant feedback to potentially reduce patient burden
- Consult clinical sites early for their input into standardized participant feedback tactics to better enable rapid identification of actionable participant insights and facilitated implementation of mitigation actions at site level
- Standardize the collection of participant feedback within the organization, to enable cross-study aggregation of data for identification of significant insights not possible at an individual study level (e.g., identify specific patient populations with low patient experience)
- Clearly define how to analyze, visualize and interpret patient experience data
- Provide study teams access to the data in real-time to better enable actionable insights at study and site level
- Provide sites with aggregated (anonymized) learnings to better enable them to take actions to potentially improve patient experience at their site
- Provide patients with aggregated (anonymized) feedback and actions taken to demonstrate to them the value of providing feedback and help motivate further engagement with clinical trials
- Embed the process to collect, analyze and interpret patient experience feedback into existing processes to help limit burden on study team
Value and Potential Benefits
- Provides study teams with actionable feedback so they can take steps to reduce burden on current and future studies to potentially improve the patient’s experience in clinical studies
- Increases patient adherence and compliance to clinical study procedures, which consequently improves the data quality
- Increases trust and engagement through better communication and participation in feedback processes
- Potentially increases recruitment into trials and reduces study participant dropout rates
Tools & Resources
Resource Name |
Brief Description |
Authoring Organization |
|---|---|---|
|
The SPFQ is an in-trial questionnaire provided to study participants at the beginning, middle and end of a clinical study. The SPFQ toolkit consists of a validated questionnaire template, a socialization deck and an implementation user guide. |
TransCelerate BioPharma, Inc. |
|
|
Infographic: Toolkits to Help Amplify The Patient Voice in Clinical Research |
An infographic highlighting:
|
|
|
Manuscript that evaluates the content and cross-cultural validity of the SPFQ in other indications and non-English-speaking countries. |
||
|
Engaging patients as partners to obtain meaningful insights on clinical research |
A variety of tools and methods designed to engage patients and care partners and obtain meaningful insights to help inform protocol designs and operational strategies. |
Center For Information and Study on Clinical Research Participation (CISCRP) |