TransCelerate Helps Drive Innovation in Clinical Trials at SCOPE

Last week, seven of our members travelled to Orlando, Florida to represent TransCelerate work at the 2023 Summit for Clinical Ops Executives (SCOPE) conference. Over the course of four days, attendees from sites, sponsors, academia, vendors, and other stakeholders convened to share learnings and new releases that positively impact how clinical trials are designed and operated.

TransCelerate had a robust presence again this year whether through our sessions or mentions of our work by industry leaders who have previously contributed to or led TransCelerate work. For example, Virginia Nido (Roche) was Tuesday’s keynote speaker, asking the question, “Would I want my mother in a clinical trial?”. Though she is not currently an active member contributor, she walked the audience through the real, available, free solutions that TransCelerate and other collaborations have released to make trials safer, faster, and of a higher quality. Seeing the vast amount of TransCelerate solutions available in every phase of a study was very impactful for the audience, which was on the edge of their seat for the discussion.

Read on for a brief overview of each of our sessions.

The Renovation of ICH Good Clinical Practice – TransCelerate Framework for ICH E8

Madeleine Whitehead (Roche) and Melissa Suprin (Pfizer) hosted our first session of the week on the real-life application of the elements of ICH E8 on Good Clinical Practice. Maddie’s presentations of TransCelerate’s case studies clearly communicated the impact for the audience, particularly the case study around culture and engagement. Many of those in the packed room agreed that it would be wonderful to have that open dialog with regulators about innovation in order to get to the right outcome.

Transforming Clinical Trials of the Future: A Look into Clinical Trials 2031 & Beyond

Hassan Kadhim (BMS) presented at this standing-room-only session. Hassan delved into TransCelerate’s Modernizing Clinical Trial Conduct deliverables to transform clinical trials of the future to be more patient-centric, including the introduction of our scenario-planning methodology, “Clinical Trials 2031 and Beyond,” to explore the potential drivers influencing the future of clinical trials and considerations for enabling participant data return.

Operationalizing Diversity in Clinical Trials: Cross-Functional Capabilities Needed to Recruit, Track, & Adapt for Meaningful Change

Alekhya Pochiraju (Genentech) from our Diversity of Participants in Clinical Trials Initiative joined a panel to offer tips on improving Diversity, Equity, and Inclusion (DE&I), beyond trial entry criteria. Alongside speakers Jamie Brewer (FDA), LaShell Robinson (Takeda), Shiela Rocchio (eClinical Solutions), and Cassandra Smith (Janssen R&D), they fielded questions on how to make a meaningful difference to ensure clinical trials better reflect the population most likely to use the drug if approved.

Practical Tools Available to Advance Fit-for-Purpose Use of Real World Data (RWD) in Regulatory Decision-Making 

Robert Kalesnik-Orszulak (BMS) debuted TransCelerate’s two recently released tools that aim to increase fit-for-purpose use of Real World Evidence (RWE) and Real World Data (RWD) in regulatory decision-making. As the industry progresses in its ability to leverage reliable health-related data and develop more sophisticated analytical capabilities, the potential applications of RWE and RWD continue to expand. In turn, Health Authorities are more apt to consider RWE/RWD to inform, supplement, or replace clinical trial data if sponsors demonstrate fit-for-purpose use, derive relevant and reliable regulatory-grade data insights, and embrace a credible and compelling approach to Health Authority engagement. These proposals work to help reduce barriers utilizing this data and build trust with Health Authorities.

Novel Evidence for Regulatory Decisions, the Key Factors for Success

Michelle Crouthamel (AbbVie) moderated this panel of experts, which included Amy Abernethy (FDA), Christopher Boone (AbbVie), Jennifer Goldsack (Digital Medicine Society), Lada Leyens (F. Hoffmann-La Roche Ltd.), and Michael Benecky (UCB). This panel was an informal conversation that spoke about the real-life use of the novel evidence and how it can be applied in the future to support regulatory decisions. There were so many people coming up to them to ask and engage after the session that the moderator had to make an announcement to say the session needed to wrap up for the next one!

The Value of Incorporating Patient Voice, Obtaining Patient Feedback, and Demonstrating Gratitude Throughout the Clinical Trial Journey

Kandria Harry (Astellas) maximized her session time to give an overview on all TransCelerate’s Patient Experience tools – the Study Participant Feedback Questionnaire, Patient Protocol Engagement Toolkit, and Gratitude Toolkit. The crowd enjoyed the real-life applicability and the presented use case where one company implemented the tool based on a patient request.