Impact of adaptive trials on the pharma IT landscape
Adaptive clinical trials have the potential to lower cost, reduce time to market and increase patient safety.
By on Oct 30, 2007Adaptive clinical trials have the potential to lower cost, reduce time to market and increase patient safety.
The pharmaceutical industry is facing many challenges like the high cost of R&D, competition from generics, failure of the blockbuster model, weak pipelines and lengthy times to market. Adaptive clinical trials, however, have the potential to lower cost, reduce time to market and increase patient safety.
The traditional approach to clinical trials, while very rigorous and focused, is also quite inflexible. In a typical clinical trial, the safety and efficacy data is captured in different sites and monitored on a regular basis by a data monitoring committee (DMC). However, this review is only to ensure the safety of the subjects. The committee can-at the most - stop the trial on the safety grounds, but cannot change any of the key parameters linked to the outcome, sample size or treatment groups. Many times, follow-up studies are needed to further analyze some of the observations from a traditional clinical study.
Given the large amount of time, effort and money needed to conduct clinical studies: this considerably increases the cost and time to market for a new drug. In addition, it also subjects some patient populations to be exposed to ineffective therapies.
An adaptive approach to clinical trials is an emerging concept that allows responding to the safety and efficacy data in various ways: e.g. narrowing down the focus of the clinical trial by removing one or more treatment arms, increasing the patient population if there is no clear indication between utility and futility, stopping the clinical trial if statistical significance has already been achieved and so on.
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Author: Verender Kumar and Dr. Nandini Diwakar, Principal Consultant & Business Analyst, respectively, Infosys Technologies Ltd.