The SCOPE Summit focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management, and operations. TransCelerate’s initiatives represented include Patient Technology, Patient Experience, Real World Data, Interpretation of Clinical Guidances & Regulations, and Modernizing Clinical Trial Conduct.
TransCelerate presentations at the 2023 SCOPE Summit:
- Panel Discussion: Digital Technologies to Enable Decentralized and Hybrid Clinical Trials with Michelle Crouthamel (AbbVie)
- The Value of Incorporating Patient Voice, Obtaining Patient Feedback, and Demonstrating Gratitude Throughout the Clinical Trial Journey with Kandria Harry (Astellas): This session will focus on TransCelerate’s work to provide more effective ways to engage with and embed the voice of patients in the design and execution of clinical studies. In addition to highlighting the impact and value of TransCelerate’s existing Patient Experience Resources: The Patient Protocol Engagement Toolkit (P-PET) and the Study Participation Feedback Questionnaire (SPFQ) Toolkit, there will be an introduction to the newly developed Gratitude Toolkit.
- Improving Diversity of Clinical Trial Participants: Efforts to Enhance Health Equity with Alekhya Pochiraju (Roche)
- Practical Tools Available to Advance Fit-for-Purpose Use of Real World Data (RWD) in Regulatory Decision-Making with Robert Kalesnik-Orszulak (BMS): Two recently developed tools, now publicly available, aim to increase fit-for-purpose use of RWE/RWD in regulatory decision-making will be presented, including proposals for reducing barriers and building trust with health authorities.
The Renovation of ICH Good Clinical Practice – TransCelerate Framework for ICH E8 with Madeline Whitehead (Roche) & Melissa Suprin (Pfizer): ICH’s renovation of Good Clinical Practice (GCP) achieved the first milestone with the release of revision 1 of ICH E8 General Considerations of Clinical Studies. The updated ICH E8 represents a philosophical shift in the conduct of clinical research, promoting a proactive, risk-based approach, and definitively moving away from a one-size-fits-all, linear application. TransCelerate has developed a framework focusing on the elements of ICH E8 (R1) identified by member companies as essential for successful implementation and to prepare the path for the release of ICH E6 (R3) which sets the operational parameters required.
- Transforming Clinical Trials of the Future: A Look into Clinical Trials 2031 and Beyond with Hassan Kadhim (BMS): This session will focus on TransCelerate’s work to transform clinical trials of the future to be more patient-centric, including the introduction of a scenario-planning methodology to explore the potential drivers influencing the future of clinical trials and considerations for enabling participant data return.