June 14, 2021 | Industries across the world have been rocked by the pandemic, and it’s hard to say where the impact was greatest, but certainly among the contenders is clinical trials and clinical research. While facing the greatest clinical research challenge in recent history, our industry has simultaneously dealt with constraints of reaching and serving patients who desperately needed consistency of both care and innovation.  

Next month, the team behind SCOPE is launching a two-day Clinical Research Leadership Forum. The event brings together an international group of clinical research innovators, trial designers, clin ops leaders, R&D heads and technologists to have real conversations about leadership in the rapidly changing world of clinical research.

It will be a rich two days, but the virtual format will allow for returning to the content again and again to get the most value. With that flexibility in mind, here are some of the conversation threads we’ve flagged. –The Editors

Decentralized Trials

Decentralized trails are the understandable topic of myriad conversations in clinical research right now. Anthony J Costello, President, Patient Cloud, Mobile Health, Medidata, will lead a panel discussion on meeting patients where they are. 

In a separate panel, a team from GlaxoSmithKline will share how they responded to the pandemic and used partnerships and collaborations to drive novel mechanisms for patient identification and engagement, improved diversity, and gained actionable patient insights. 

Takeda Pharmaceuticals also shifted culture during the pandemic. A group from Takeda will share how they view the patient voice as North Star to facilitate decision-making to optimize digital strategy and achieve decentralized trials. 

Craig Lipset, now Co-Chair, Decentralized Trials & Research Alliance (DTRA), will lead a cross-industry panel in exploring use cases to integrate high quality diverse real-world data within decentralized trials; describing RWD frameworks specific to decentralized trial needs; and understanding how RWD can fill data gaps and support broader decentralization. 

Melissa Easy from IQVIA, will explore the data capture devices and remote monitoring capabilities that are critical to decentralized research. 

Kyle Holen from AbbVie will facilitate an open discussion of forum attendees in the first Breakout, exploring the direct-to-patient model, how it can scale, opportunities for sponsor collaboration, and what geographies could limit our scope.

Finally, in Breakout #3, Craig Serra from Novartis Pharmaceuticals will facilitate an open discussion of forum attendees as we discussion best practices, case studies, challenges and bottlenecks from our experiences with decentralized trials in the past 12 months and chart a way forward.  

AI and Machine Learning 

Sotirios Perdikeas, of Roche Pharma, will discuss how machine learning can enable site and investigator selection. 

A cross-industry panel with speakers from PhESi, Incyte Corp, and Alfasigma SpA Pomezia will explore how AI and machine learning can optimize study design and the role of digital twins—synthetic data—in reducing study costs. 

Corporate Responsibility and Waste 

Led by Jason LaRoche, Clinical Innovation Leader, Janssen Pharmaceuticals, members of a new cross-industry consortium will take on the emerging challenge of digital health waste. While the benefits of digital health devices has been heralded by industry and regulators, little attention has been paid to the environmental impact of these devices at the end of their use, the consortium warns. 

In a companion panel, representatives from Sanofi, Bayer, and Kits4Life will take on the waste inherent in clinical research consumables and how a solution from Kits4Life can repurpose unused surplus for in-need areas.