FDA is launching the Rare Disease Framework Initiative, aiming to tailor drug development and review requirements to the realities of small patient populations.
|Articles|June 23, 2015
Optimizing Clinical Trials Using Electronic Measurement and Analysis of Drug Adherence
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Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority
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Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority. However, suboptimal adherence is prevalent in ambulatory trials, in which outpatients are responsible for taking the drug according to the protocol-specified dosing regimen. Unfortunately, most methods for measuring medication adherence are inaccurate, which can result in costly phase III failures. This whitepaper focuses on a proven exception-automatic adherence measurement through electronic compilation of drug dosing histories. Electronic measurement enables a better understanding of drug safety and efficacy data, improving the likelihood of a successful trial outcome and more informed development decisions, leading to faster speed to commercialization.
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