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European Biopharmaceutical Review

Adapt to Win

Worldwide investment in pharmaceutical R&D has soared in the past decade (see full pdf). However, the failure rate of clinical trials remains high, with 70% of Phase 2 trials and 50% of Phase 3 trials unsuccessful (see full pdf). This has resulted in low drug approval rates, with the FDA overseeing an average of only 26 successful submissions per year from 2004 to 2014 (see full pdf). This means higher costs for authorised drugs (see full pdf).

Adaptive Trial Design


The failure of a clinical study is often due to the lack of efficacy or unacceptable toxicity of the investigated medication. To improve success rates – and, simultaneously, reduce costs and enhance trial participant outcomes – the increasing use of adaptive designs, biomarkers for surrogate endpoints and treatment stratification, as well as the utilisation of simulation techniques to predict trial success rates and compare alternative designs, may be the solution. The drug development dilemma became known as the ‘Pipeline Problem’ and, in March 2006, the FDA published the ‘Critical Path Opportunities Report’ (see full pdf). This report detailed a number of approaches to address this issue, including the use of accumulating information in study designs, leading to a belief among many researchers that the FDA encouraged socalled adaptive designs to be employed in clinical trials.

Adaptive designs for clinical trials provide an alternative to traditional, fixed framework studies whereby the accumulating data – either blinded or unblinded – are examined at various stages and predefined decision rules are applied to potentially modify key trial characteristics. This is done in order to improve the study design or terminate the trial based on efficacy, futility or safety. The decision-making process is implemented in a pre-planned manner and without undermining the study’s validity or integrity. This adaptive approach could allow for faster clinical trials that flexibly identify superior treatments earlier, with savings in both time and cost. It may also expose fewer participants to suboptimal therapy and enables medicines to reach patients sooner.

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Dr Bernard North is a statistician with over 20 years’ experience in medical departments in various academic institutions and has worked extensively with medical statistics from clinical trials. As Statistical Consultant and Applications Specialist at Exploristics, he provides support and advises on analysis and design options for clients, application notes and scientific publications for the statistical services team and its in-house simulation platform.
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