Chief Medical Officer; President, Clinical Pharmacology Labcorp Drug Development
Over the last decade, the traditional sequential approach to early phase clinical studies has given way to increasingly complex adaptive hybrid studies. Study designs that include patient cohorts are now seen more routinely as sponsors seek early pharmacodynamics signals in addition to traditional safety and pharmacokinetic endpoints. There are theoretical benefits of economies of scale with respect to time, cost, and management oversight to running hybrid protocols. However, practical challenges must be recognized and mitigated, especially with regard to inclusion of patient populations. Particular attention to the specific patient population and inclusion/exclusion criteria are essential. This presentation explains some of the challenges faced by clinical pharmacology teams managing early phase clinical trials in patients, focusing on the key considerations and importance of developing robust strategies and leveraging therapeutic expertise.
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