Aug 15
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
Related Blog Posts
A New Era in Advancing Care for Pregnant and Breastfeeding Patients
One major challenge facing the clinical research ecosystem is not whether, but how to study drug safety and efficacy in pregnant and breastfeeding populations. A growing number of organizations—including the ICH E21 Expert Working Group (EWG) and TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative—are diligently seeking ethical and responsible solutions to protect these…
Improving Medicine Use During Pregnancy & Breastfeeding: Forging a Path Forward
The scientific community intended to protect pregnant and breastfeeding populations when it strictly limited their involvement in clinical trials after the thalidomide crisis of the 1950s-1960s. Yet over the past few decades, people have increasingly recognized the real-life challenges posed by the lack of research into the safety of medications used during pregnancy and breastfeeding.…
Transforming Pharmacovigilance: Solutions to Solve Regulatory Challenges
Patient safety depends partly on sponsor organizations’ compliance with pharmacovigilance (PV) regulatory requirements—even when global variations exist. Helping sponsors interpret and operationalize challenging PV regulations and guidances is the goal of TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative. In this third installment of our IGR PV blog series, we will examine the solutions…