Clinical Research As A Scientific Discipline: Birthing A Movement

By Deborah Borfitz 

February 20, 2020 | ORLANDO—A day ahead of the 2020 Summit for Clinical Ops Executives (SCOPE), stakeholders from across the clinical trials enterprise convened for a campfire-style chat on ways to elevate the status of clinical research as a scientific discipline and foster collaboration and pre-competitive knowledge sharing to improve trial conduct. The SCOPE Scientific Symposium (SSS) was led by a half dozen leaders from AbbVie, Pfizer, Biogen, Boston Millennia Partners (BMP), and the Tufts Center for the Study of Drug Development (CSDD), with more than 50 others actively engaged in the dialogue. 

Among the range of ideas proposed was adding a poster session to SCOPE, with the best peer-reviewed abstracts selected for oral presentation. Other thoughts were to collaboratively produce webinars about methodologies underlying scientific findings and compose white papers focused on common pain points. 

One particularly appealing idea was for folks in the room to function as “the Switzerland” for data-sharing, with awards and recognition for first movers. Opportunities for teamwork included how best to disseminate data back to participants, recruit for rare disease trials, increase participant diversity, and choose study sites. 

A forum for timely and active information exchange prior to publication—which can take years, if it happens at all—is the “missing link,” according to SSS panelist Kyle Holen, M.D., head of the Development Design Center, research & development, at AbbVie. For example, do studies that end with an open label extension enroll more patients than ones that do not? Based on an analysis conducted by AbbVie, the answer is yes but the practice only speeds enrollment by about three weeks. 

If companies were openly conversing on such topics, they might debate when the end justifies the means—or the significance of the analysis based on the types of studies included in the study. 

Admittedly, plenty of good content is already being presented at SCOPE that could be more widely shared. The market is hungry for original, peer-reviewed articles pertaining to clinical trial operations and the reputation of sponsor companies could be helped by showcasing their efforts to improve the patient experience.  

Methodologies behind studies might be explored at SCOPE through the creation of a dedicated learning track or, alternatively, “tagging” content across existing tracks as being peer-reviewed or data-driven. It was noted that presenters would need to be willing to document their process and given ample lead time to prepare content of this caliber.  

It was suggested that sponsor companies be engaged on-site in a friendly hackathon. Organizations might even be convinced to talk openly about what they’ve done wrong so they can learn from one another and mistakes don’t get needlessly repeated.    

Symposium participants agreed that creating examples of abstracts could seed the launch of a scientific session at SCOPE, with the highest-ranking entry getting a special award and keynote-level recognition. Pioneer Awards (a concept already under development by conference organizers) might be handed to the initial batch of abstracts that make it through the vetting process. 

The group acknowledged that everyone is busy, may be suffering from consortia fatigue, and finding and sharing data takes time—making it critical to define the structure of the movement before putting the change management process in motion. Ambassadors and peer reviewers also need to be identified and engaged as the movement’s founders start building the business case for senior leaders to get on board.  

In addition to Holen, SSS panelists included Michelle Crouthamel, Ph.D., director of digital health and innovation at AbbVie; Oriol Serra Ortiz, MBA, senior director and head of global site intelligence & selection at Pfizer; Adama Ibrahim, EMBA, associate director of performance operational capabilities, global clinical operations, at Biogen; Craig Lipset, MBA, former head of clinical innovation at Pfizer and now a venture partner with BMP; and Mary Jo Lamberti, Ph.D., associate director and research assistant professor at Tufts CSDD.