The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Charles Liu, Statistician and Product Manager at Cytel will be part of the expert speaker panel at the 7th Annual SCOPE Summit on 23-26th February. This year’s meeting is taking place in Miami, and offers a packed program with tracks covering such varied topics as risk based monitoring, clinical data technology and integration, and managing outsourced clinical trials. SCOPE has become one of the leading events on the conference calendar for clinical operations executives, with 1100 delegates from over 300 companies expected to attend this February.
Clyde Haberman, a columnist for the New York Times, once commented on the remarkable consistency of train arrival times on the Tokyo subway: "Every station lists the scheduled arrival times: 9:01, 9:04, 9:08 and so on. I lived in that city for five years...I never saw a train arrive so much as a minute late, not once. A posting of 9:01 meant 9:01." . Such predictability is rarely observed in the messy world of clinical operations, yet many study plans are formulated like a Tokyo subway timetable. In a previous blog entry , we cited an example trial that targeted 1,800 patients across 50 sites over a 10-month period. Let us examine three underlying assumptions in this plan, with the help of a modeling and simulation tool.
Two insightful papers from Applied Clinical Trials should be of interest to many clinical trial planners. The first by Kenneth Getz describes the problem of enrollment performance, while the second by Matthew Kibby proposes a potential solution.
Getz reports a study providing recent estimates of industry-wide rates of enrollment delays . In 2012, the Tufts Center for the Study of Drug Development (CSDD) requested data from 10 pharmaceutical companies and two CROs. The combined database covered nearly 16,000 investigative sites involved in 151 clinical trials from years 2008-2010. A few significant findings are worth highlighting:
Data driven decision-making can ensure that every feasibility team achieves its enrollment milestones. By transforming how pharmaceutical companies and CROs conduct feasibility studies, new techniques in recruitment planning are affecting every aspect of trial planning and clinical development strategy.
We sat down with Chris Conklin, the Director of the Feasibility Center for Excellence at Pfizer (pictured below) to discuss innovative ways to think about enrollment factors, and how he uses high-precision forecasting tools like Cytel’s EnForeSys®.
Every clinical trial requires some manner of trial forecasting, normally for feasibility and patient enrollment. However, studies reveal that more than 50% of clinical trials fail to meet enrollment targets, and that enrollment is the most commonly cited reason for Phase 3 trial discontinuation .
Last week we released an infographic on why Phase 3 trials fail. The numbers, while eye-opening, did not capture a related and equally important issue: Why are so many late stage clinical trials discontinued?
Nearly 50% of all Phase 3 trials that are submitted to the FDA fail upon first submission . However, 25% of all trials that begin are never even submitted for review . According to a 2014 JAMA study, nearly 40% of these discontinuations cite poor enrollment as the primary reason for stopping a trial. Needless to say, the costs of discontinuity are significant.