Collaboration and Competition in Clinical Trials
By Allison Proffitt
February 14, 2014 | The final keynote presentation of the Summit for Clinical Ops Executives challenged the audience to build innovation into the clinical research enterprise, and highlighted the collaborative work of TrandCelerate BioPharma.
Jackie Kent, Eli Lilly, also represented TransCelerate. The organization, launched in September 2012, aims to improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies by working collaboratively across the global biopharmaceutical R&D community.
With ten founding big pharma members and seven more joining the ranks, the organization is committed to quality and openness, Kent said, a commitment that requires a lot of courage, she added.
TransCelerate has been working on several projects and Kent said a lot of early work has been focused in the data standards space. A whitepaper on risk-based monitoring was a huge step, she said, and resulted in great engagement with FDA and EMA. A project to offer mutual recognition of GCP training between pharma companies has given sites much more freedom to spend time on protocol-specific training. The comparator drug project—where pharma members agreed to supply competitors with comparator drug samples—started small, but Kent said it has been one of the most valuable projects.
In 2014, Kent predicted “line extensions” on current projects, for example expanding the training framework past mutual recognition of GCP training. And she also highlighted some new initiatives including an investigator network, a standardized protocol template, and a network for special populations in clinical trials, specifically minority groups and pediatrics.
These types of projects—like much of what TransCelerate takes on—raised questions about competition. It’s why, Kent said, she mentioned courage early on. But for Lilly, she said, “We’ve gotten past the piece of competitive information.”
Data and Adoption
Craig Lipset emphasized that across the SCOPE summit and clinical research, data is the lowest common denominator. Diverse data helps plan smarter studies, he said. But the challenge is implementing the data you have.
Lipset was influential in Pfizer’s Blue Button pilot study, but he said he’s sick of people asking him when he’s going to run another pilot. We have the data, he stressed. Now use it! I’m not in the airline business. I don’t want to do another pilot.
Together, Kent, Lipset, and session chair Andrew Lee of Sanofi ended the session with a roundtable discussion of innovation and collaboration.
Our competition isn’t really with each other, Lee said, it’s with the perception of the pharma industry, with Big Pharma culture getting in our own way!
Both Kent and Lee agreed that common data standards are one of TranCelerate’s major deliverables. Innovation does not need to be sexy, Kent said, but should focus on ideas that create value. All three speakers encouraged the industry to rally resources around the ideas that are truly transformative.
Kent also highlighted that it’s not just new technology that can transform, but integration and new ways of working can lead to beneficial changes. TransCelerate requires both a financial buy-in and a time investment from its members. It’s a significant investment in the collaborative model.
In terms of new technology, Lipset championed the idea of “stealing” great solutions—no point in reinventing the wheel! Kent said she’d love to “steal” a great eTMF (electronic trial master file solution), while Lee said he’s searching for a health technology that really engages physicians.
For more SCOPE coverage, see the roundup of external links, opening keynote session summary, the Clinical Informatics News Best Practices winners, and the track summaries.
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