Nimbleness and Innovation Are Top Themes at SCOPE 2021

While this year’s virtual Summit for Clinical Ops Executives (SCOPE) didn’t have the Floridian sun and everyone under the same roof, the conference still provided three days of jam-packed sessions featuring insights across the R&D ecosystem.

TransCelerate had 10 sessions at 2021’s SCOPE, ranging from clinical R&D through pharmacovigilance. Read on for a summary of our sessions.

March 3

• Patient-Centered Approach for Clinical Trials…Starting at Protocol Development. Bayer’s Michelle Shogren and Daniela Franschman, BMS’s Cathy Florek, and Astellas’ Kathyjo Shay walked attendees through the development and use of the Patient Protocol Engagement Toolkit (P-PET) and the Study Participant Feedback Questionnaire (SPFQ). These toolkits aim to improve the patient experience and reduce patient burden as a study participant and are now available in 15 languages. Daniela gave an example of how Bayer has used these toolkits to aid in developing robust recruitment and retention materials for a complex pediatric trial and in another women’s health study to help guide their approach in designing a clinical trial and determining the best avenues to reach potential participants. They also provided an update on how the Patient Experience Initiative is now creating an amendment to these tools to specifically cover virtual trials.

• Pushing the Boundaries Related to Historical Trial Data Regulatory Guidance to Expedite Drug Development. Next up was Amgen’s Matthew Gribbin from our Historical Trial Data Sharing Initiative. In this talk, Matthew provided an overview of regulatory guidance related to HTD use and gave suggestions on how to expand the applicability of such methods through multiple use cases. He also presented some potential uses of historical trial data sharing in COVID-19 trials.

Matthew stressed the importance of providing high-quality data to truly optimize studies, especially now with COVID-19 causing reduced recruitment and higher trial drop-out rates. He closed out the session by encouraging greater confidence in applying these innovative methods into practice.

• Lessons from TransCelerate’s Digital Data Flow Virtual Hackathon: Interoperability, Digitized Protocols, and a Common Data Model. Novartis’ William Illis delivered an informative overview of lessons from TransCelerate’s Digital Data Flow Virtual Hackathon. In his session, William shared the evolution of enabling end-to-end data from development of a conceptual design for a study builder. He also discussed the many takeaways and key learnings from the Hackathon such as further validating the architecture and running surveys to gain more feedback from participants. William notes that while there is plenty of work to be done, now is an ideal learning opportunity on industry alignment and collaboration.

• Increased Clinical Research Resilience through Essential RBQM Feedback Loops. While not an official TransCelerate session, Member Company expert Melissa Suprin gave a presentation on how Pfizer implemented TransCelerate’s Risk Based Monitoring and Quality Management System solutions and some best practices to help sponsors lay a foundation for risk-based quality management (RBQM).

• Implementing New ICH Recommendations: TransCelerate Amendment Metadata Initiative. Closing out the first day was an interactive breakout session moderated by Merck’s Mitzi Allred, Sanofi’s Hena Ashar, and Novartis’ Sharon McErlean. TransCelerate’s Amendment Metadata team, part of the Clinical Content & Reuse Initiative, aims to develop proposed metadata for amendments in response to a request for input into upcoming standards-setting by the International Council for Harmonisation (ICH). The presentation is timely, as the current state of describing protocol amendments is not sufficient for reviewers to understand the details of the amendment and “everyone is doing their own thing.” It also makes integration manual and expensive for the sponsor. Mitzi, Hena, and Sharon discussed TransCelerate’s proposed recommendations for consideration by ICH, including identifying core elements of change for downstream alignment similar to that already achieved with clinical content reuse across the Common Protocol Template (CPT), Statistical Analysis Plan (SAP), and Clinical Study Report (CSR).​

March 4

• A Privacy Framework for Clinical Data Reuse. The life science industry has potentially missed opportunities to advance scientific research and benefit public health due to the difficulty of interpreting legislation concerning data privacy and contradictory guidance and opinions from competent authorities. To help navigate the uncertainty around clinical data reuse, Amgen’s Lynn Wetherwax showcased TransCelerate’s model framework for secondary research based on personal data and presented six proposed principles on for data processing for reuse.

• A Decentralized Hybrid Model for Remote Monitoring: The eSource Opportunity. BMS’ Joe Dustin and Merck’s Rakesh Maniar explained the potential role of eSource technologies in clinical trials and best practices on how sites and sponsors can work together using technology to monitor patients remotely in real-time and evolve from the still-commonly used paper binder to a digital approach. The session dived deep into the four modalities of eSource: Electronic Medical Records/Electronic Health Records (EHR/EMRs); devices and apps; non-CRFs; and Direct Data Capture. They closed out the session by highlighting TransCelerate’s participation in the Vulcan FHIR Accelerator, emphasizing the impact that it can have beyond sponsors to sites and other key personnel alike.

March 5

• Implementing Intelligent Automation Technologies for Individual Case Safety Reporting. AbbVie’s Neal Grabowski demonstrated how our Intelligent Automation Opportunities in Pharmacovigilance Initiative can help identify ways intelligent automation technologies can support and improve the execution of pharmacovigilance (PV) activities and processes. Using the Individual Case Safety Reporting (ICSR) process as a case study, he introduced foundational terminology, information about various attitudes toward intelligent automation, applicable technologies, and validation considerations. He closed the session with a demo of our new interactive ICSR & Automation Technologies Tool (IATT), which helps to identify the level of opportunityfor process automation, as defined by current level of effort, level of benefit from automation, and level of risk from automation.

• Balancing Patient Safety, Quality and Data Integrity: Lessons Learned from Remote and Centralized Monitoring Implementations. Merck’s Rakesh Maniar had two other back-to-back sessions at SCOPE. The first panel discussed the challenges in implementing remote and centralized monitoring processes in a global organization.

• Overcoming Challenges to Technology Adoption in Clinical Trials. The second session was a live Q&A on possible ways to incorporate technology into site operations and the site selection process, whether it’s through eConsent or Site Qualification Training.

• Pandemic-Proof Trials of 2030: Applying Lessons Learned from COVID-19. Wrapping up the entire conference was a live panel featuring TransCelerate Chief Operating Officer Janice Chang. This session discussed what processes developed or implemented during the COVID-19 pandemic companies may wish to consider carrying into future trials. Janice stressed how now is the opportunity to see analyze what worked and what didn’t. For those non-traditional technologies that may still be of use in the future, she highlighted that its success is partially depending on training people virtually so that they are empowered in the new courses of action.

TransCelerate would like to send its sincere thanks to SCOPE and the Members who shared the work of so many colleagues across TransCelerate Member Companies. We are looking forward to our participation in next year’s event.