Empirical Study Confirms Positive Impact of Adaptive Designs

Posted by Esha Senchaudhuri

Sep 11, 2014 11:56:00 AM

According to a recent Impact Report from the Tufts Center for the Study of Drug Development, 21% of active clinical trials improve trial success rates and cut operating costs by designing trials with simple adaptive elements like sample size re-estimation and opportunities for early stopping. 

Cytel Senior Biostatistician Zoran Antonjevic, who also chairs the DIA’s Adaptive Design Scientific Working Group (ADSWG), says the CSDD's findings come very close to the numbers reported by the ADSWG. The ADSWG recently updated its published findings in a Therapeutic Innovation & Regulatory Science article entitled, ‘Adaptive Design: Results of 2012 Survey on Perception and Use.’ The Survey team, led by Cytel statistician and Senior Director Caroline Morgan, used a variety of source material to report on adaptive designs in clinical trials between 1996 and 2012.

The CSDD Impact Report also concludes that adaptive designs and strategic upfront trial planning are playing a key role in improvements to data quality, trial success and reduced trial costs. However, many sponsors still expend much time and effort on acquiring data that is not central to trial objectives. In fact, the average trial directs one quarter of its budget towards non-core data. According to Ken Getz, the director of the CSDD, "Our research has shown that the push to collect more data and increase clinical trial complexity is associated with higher levels of drug development risk, cost, and inefficiency." 

How can you determine whether your next trial will benefit more from a simple adaptive design or a complex trial? One place to start is by reading our white paper Adaptive Clinical Trials or looking at our 10 step guidance 'To Adapt or not to Adapt? 10 Simple Steps to Determining whether your Next Trial Should be Adaptive.' 

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Related Items of Interest

Morgan, Caroline Claire, et al. "Adaptive Design Results of 2012 Survey on Perception and Use." Therapeutic Innovation & Regulatory Science (2014): 2168479014522468

Nayak, R. and Bolognese, J. Adaptive Clinical Trials. Cytel Whitepaper. 

Cytel Blog, To Adapt or not to Adapt? 10 Simple Steps to Determining whether your Next Trial Should be Adaptive


Topics: White Paper, Adaptive Clinical Trials

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