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R. Suthakaran*


Although research and development expenditure in the pharmaceutical industry is constantly increasing, the number of medicinal products put through clinical development up to marketing authorization is not increasing in equal measures. In fact, a decline in marketing approvals can be seen. On the other hand, there are still a lot of therapeutic areas where adequate treatments are still not available, thus a high unmet medical need exists. This circumstance led the FDA (Food and Drug Administration) to launch its "Critical Path Initiative" in 2004. This initiative included the "Critical Path Opportunities List" that was set up to foster clinical development and help sponsors in identifying opportunities to accelerate drug development. One of the items listed here is adaptive trial design as a means to streamline clinical trials and enhance drug development. With the EMA (European Medical Agency) releasing its "Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design" in 2007 and the FDA following with its draft guidance on adaptive design clinical trials in 2010, a first step towards encouraging pharmaceutical industry as well as other researchers to implement adaptive features into the clinical development of their compounds has been taken. Since then a slight increase in the usage of adaptive design clinical trials can be observed, either in the review of recent marketing authorization applications as well as in the number of medical publications referring to this topic, but vast experience is still lacking. The present article provides an overview of the different types of adaptive design clinical trials as well as their classification and assesses the inherent risks and opportunities. It elaborates that adaptive designs are not feasible for all types of clinical trials, but rather exhibit their advantages in specific settings, for example in trials with IMPs with an immediate treatment effect, where dose flexibility is given (for example trials with liquid IMPs), in trials with a limited number of sites or for trials where data cleaning can be easily performed. This article additionally contains an evaluation of how and to what extent adaptive design clinical trials are currently adopted by pharmaceutical industry and accepted by the two major regulatory authorities EMA and FDA. Beside the results of a recent survey by the ADSWG, it also provides an overview on which recent marketing authorization applications were based on one or more clinical trials incorporating an adaptive design feature including the EMA´s and/or the FDA´s assessment of the trial design. The results suggest that regulatory authorities encourage sponsors to make use of adaptive design features, but also ask for early and intensive dialogue between authority and sponsor. The evaluation reveals that until now not much practical experience with adaptive clinical trial designs appears to be available and both pharmaceutical industry and regulators are still on the learning curve. However, the concluding outlook presented in this thesis suggests that the increasing transparency on clinical trial data that regulatory authorities are currently promoting might eventually foster consideration and usage of adaptive designs as it provides a basis for mutually sharing experience with adaptive designs.

Keywords: FDA, EMA, ADSWG, IMPs.

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