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International Clinical Trials

Value Added Trials

The interest in the use of adaptive clinical trials is definitely rising – but why? Tom Parke of Tessella considers the expectations for these methods, and what they can offer

We are well versed in the pressures facing the pharmaceutical industry. Effective new compounds are becoming harder to find and harder to develop – the number of new drug registrations is falling and the time and cost of development is climbing. Society and regulators are becoming increasingly sensitive to potential safety issues, the diseases where there is still no effective treatment are usually the ones that are harder to study, and the compounds being found are often more difficult and costly to manufacture. Increasingly, regulators want sub-group analysis, which may help us identify the population where a compound is strongly effective, but in doing so drastically shrink the market for the compound.

ADAPTIVE CLINICAL TRIALS TO THE RESCUE?

One of the areas where pharmaceutical companies are trying to redress the balance is by running smarter and more sophisticated clinical trials. These require central randomisation to allocate a subject to a dose at the last possible moment. Initially, this was to allow the randomisation to be balanced, not just across the whole trial, but also within potentially significant sub-groups (old and young, male and female, and so on). Increasingly, the reason is to allow the randomisation to select which dose to give in order to optimise the way the trial learns about the dose response of the compound.

However, the more thirsty and sun-scorched a man is, the more likely he is to see a mirage. We shouldn’t seize on adaptive clinical trials simply from desperation because it is the current industry buzz phrase, or in the belief that they will magically transform the success rate of the drug development pipeline.


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Tom Parke joined Tessella in 1996, and has worked on supporting adaptive clinical trials since 1998. 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 fifth 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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