The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
While adaptive designs can deliver significant benefits to clinical development- including ethical benefits for patients, reduced costs, and improved likelihood of trial success- they are not suitable for every clinical trial. In making the assessment of whether or not to choose an adaptive design, trial planners need to weigh the strategic benefits against the practical implications.
We have previously discussed on the blog, the 10 steps proposed by Jim Bolognese and Ranganath Nayak to assist sponsors in making this decision. In this blog, we are delighted to share a simple infographic outlining the process.
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.