Information Sharing & Harmonization
- Momentum around the DataCelerate® platform continues to build. The Placebo and Standard of Care studies will be migrated into DataCelerate® by year end. We are also seeing an uptick in blinded study requests from participating member companies over the past months, which reflects an increase in the desire to utilize the data.
Improve the Patient & Site Experience
- The Patient Experience Initiative launched an assets page with two new resources—the Patient Protocol Engagement Toolkit (P-PET) and the Study Participant Feedback Questionnaire (SPFQ) Toolkit:
- The P-PET is a comprehensive set of materials that sponsors and other stakeholders can use to engage patients during protocol development. This toolkit includes a sponsor-facing operational user guide, resource guide with a question bank, and template to enable study sponsors to engage with patients during clinical study design.
- The SPFQ is a survey that can be provided to study participants at the beginning, middle and end of a clinical trial. The toolkit includes a socialization presentation for initial sponsor discussions, implementation user guide and set of three Study Participant Feedback Questionnaires.
- The Clinical Research Access & Information Exchange Initiative temporarily released its Clinical Trial Registration Tool to garner public feedback. The tool may assist sponsors in making their clinical trial registry submissions more patient friendly and adherent to government-owned registry requirements. The final version of the tool is planned to be released in December.
- The eConsent team published a new manuscript in Therapeutic Innovation and Regulatory Science, titled, “Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption.” This paper suggests that while the appetite for eConsent is increasing, industry stakeholders must continue to raise awareness, communicate and collaborate to develop appropriate technological capabilities, regulatory pathways and operational processes to clear the path for mainstream use of eConsent. Give it a read here.
- As of August 2019, the Shared Investigator Platform (SIP) has reached approximately 34,000 registered site users, a jump of approximately 27,500 users from August 2018. Visit this page to learn more about SIP.
Enhance Sponsor Efficiencies & Drug Safety
- The Protocol Deviations Initiative released a toolkit consisting of several new assets, including the Protocol Deviation Process Guide, Protocol Deviations Map, and Protocol Deviations Assessment Plan. This toolkit was developed with feedback from the FDA to provide a holistic approach to protocol deviations management, including a proposed clarified definition of important deviations, application of ICH E6 (R2) risk-based and issue management components and end-to-end process components. Check out the available assets, including an educational webinar, here.
- The Data Monitoring Committee (DMC) team launched its new assets page, which addresses the limited and diminishing number of experienced and qualified Data Monitoring Committee members. This DMC toolkit includes a proposed Prototype Registry proof of concept and DMC Apprenticeship Model based upon the foundational work of the Clinical Trial Transformation Initiative’s (CTTI) DMC Expert Working Group’s recommendations. The following assets are now available:
- DMC Registry Prototype Video: Provides a video overview of the DMC Registry prototype and concept. The Registry is envisioned to be a venue for showcasing a candidate’s skills, interest and experience. In the proposed concept, clinical trial sponsors looking to convene a DMC could access this information to identify potential candidates to serve as DMC members, ensuring efficient and effective staffing to these critical committees.
- DMC Registry Protocol eBook: Demonstrates the purpose and functionality of the proposed DMC Registry concept.
- DMC Apprenticeship Model: Provides a high-level overview of the proposed Apprenticeship Model, which intends to expose clinical research professionals with little to no prior DMC experience, who are interested in serving on a DMC, to the interim data monitoring process firsthand.
- Quality Tolerance Limits (QTL), as part of the Interpretation of Guidances and Regulations Initiative, released its draft framework to aid sponsors’ ability to improve the quality of clinical research through the implementation of QTLs that meet Health Authority expectations, facilitate efficiency, and minimize confusion and duplication of effort. The full guidance will be available to the public in early 2020.