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Clinical Trial Optimization Podcast

New Benchmarks on Protocol Design Practices and their Impact on Clinical Trial Performance and Efficiency with Ken Getz and Linda Sullivan

EPISODE 15

How are benchmarks on protocol design practices changing and what’s the impact of the exploding number data points in clinical trials? That’s one of the important issues discussed in Ken Getz’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Getz is the newly appointed director and a professor at the Tufts Center for the Study of Drug Development (CSDD), Tufts University School of Medicine. Getz discusses the results of a recently released study by the Tufts CSDD, which updated previously published benchmarks while also exploring new clinical trial developments, including the collection of data points. One key takeaway from the study, according to Getz, is that when you connect longer cycle times, higher costs, and poor retention, you must arrive at one inescapable conclusion; It’s becoming more difficult to predict how any given protocol will perform and whether it will be meet expected deadlines. Another key takeaway: In typical Phase 3 clinical studies, there are now more than 3.5 million data points, which is about three times the number of data points collected ten years ago in similar studies. A final takeaway, Getz notes, is the challenge they encountered benchmarking the impact of protocol complexity on study timelines because many companies utilize “moving plan targets”. As far as post-COVID clinical trials are concerned, the space will continue to be complex and customized and better outcomes will be achieved only if we revise standards operating procedures, according to Getz.

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