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The Value Proposition

Pharmaceutical and biotech companies are increasingly interested in the use of ‘adaptive’ clinical trials to improve the process of drug development. By an ‘adaptive trial’, we mean a trial that is designed from the outset to review key response data as we collect it, and carry out certain pre-specified adaptations in the light of what we learn.

In large confirmatory trials, regulatory concerns will limit adaptations that can be considered to actions such as stopping the trial early, performing a sample size re-assessment or dropping a treatment arm. In early phase trials, frequent adaptation and a wider scope for adaptation are permitted, for instance: frequent optimisation of the probabilities of adaptation to the different treatment arms; more frequent interims to choose to drop or add treatment arms or to stop the trial; modification of inclusion and exclusion criteria to drop patient subpopulations from the study or restrict the study to a sub-population.

 


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Tom Parke joined Tessella in 1996, and has worked on supporting adaptive clinical trials since 1998. He managed the development of the system that allowed Pfizer to run their groundbreaking ASTIN trial, and has worked on numerous further dose response adaptive trials. He has overseen the development of algorithms, simulation tools and systems to support adaptive trials, as well as integrating adaptive algorithms with existing central randomisation and electronic data capture systems. Whilst currently working on his twelfth dose-response adaptive trial, Tom is consulting with a number of international pharmaceutical companies, helping them to define the software systems they require to run adaptive clinical trials.

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