Allison Cuff Shimooka of TransCelerate Biopharma Discusses Innovation in Clinical Research

ACT: How is FDA promoting innovation in clinical trial design and conduct?

Cuff Shimooka: It’s a timely question, having just got off a panel discussion with Kevin Bugin from FDA about innovations in clinical trials, so really good time to talk about it. I think the thing that comes to mind for me that’s top of mind is just the new center that they’ve launched, the C3TI, which is the new Center for Clinical Trial innovation. I think they recognize that while they have promoted a lot of testing and piloting of clinical trial innovation, we haven’t made the progress that everyone would like. By this point, I think that there was a hope that there would be more scaling and more trials that are being done end-to-end for registration with innovative elements and just not where we need to be. As you know, they are taking on this challenge and really trying to build some infrastructure to help foster the collaboration that’s going to be necessary to make innovative trial designs less pilot and more just regular practice.

ACT: What should industry stakeholders such as vendors, CROs, sponsors, etc be keeping top of mind when it comes to innovation?

Cuff Shimooka: A couple things come to mind for me. One is being very cognizant about not over complicating things. I think sometimes what happens is everyone’s trying to differentiate themselves, and in the process, you can make things more complex and not less complex. Innovation really needs to be more about simplicity and interoperability and making it easier for sites and sponsors to participate and I think we talk about that as the goal a lot, but right now, I think if you talk to a lot of patients, talk to a lot of sites, that’s not what they’re experiencing on the ground. In order to make that division of things being simpler; a reality, there has to be more collaboration, sharing about how can we work together to bring the pieces together, to make them more interoperable, so that we have a simpler system and make it easier for patients and sites to participate in trials.

ACT: Looking forward in five years, what are some innovations in clinical research you hope to see?

Cuff Shimooka: My dream, and I don’t think it will be in five years, it’s going to be longer, is we have this aspiration to see the convergence of clinical research and clinical care. By that, I mean the idea that any patient, when they go to see their physician, it is completely normal, and they would expect for the physician to talk to them about potential clinical trials that they could participate in, and that the patient would be able to participate in that physician’s office and not necessarily have to travel anywhere, that the data would be collected more easily, that participating in the trial would mean excessive visits or more complexity. That’s my vision, that we can make progress towards that. I’m not unrealistic. We won’t have everything solved in 10 years, but my hope is that we will have made more meaningful progress. The thing I always think about is we often talk about how only less than 3% of patients in the United States participate in clinical trials. If we could just even double that, that would be huge, tremendous, right? I have to believe, with all the innovation and technology we have available to us today, that that is achievable, but that will only be possible if we all collaborate and work together. This is not a solution that any one stakeholder is going to be able to solve on their own.

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