Drug Development – Quo Vadis?

Drug Development Program – Quo Vadis?

Today it is known that many pharmaceutical companies are investing in their drug development programs not only based on the traditional-classical trial model, but also on adaptive trials in order to reduce time and cost, to minimize toxicity, helping to select the best dose for the patients, and targeting better populations.

Over the last few days, I read a very motivational book entitled “Adaptive Design Theory and Implementation Using SAS and R” by Mark Chang, which offers several worthwhile approaches for implementation of adaptive design methods in clinical trials by using various adaptive designs, such as:

– Group sequential design (GSD)
– Sample-size adjustable design (SSR)
– Drop-losers design (DLD)
– Adaptive randomization design (ARD)
– Adaptive dose-escalation design
– Biomarker-adaptive design (BAD)
– Adaptive treatment-switching design (ATSD)
– Adaptive dose-finding design
– Combined adaptive design

One of the conclusions of this book is that, Adaptive Designs should be encouraged for Phases I and II trials for better exploration of drug effects, whether beneficial or harmful, so that such information can be more optimally used in latter stages of drug development. As pointed out by FDA “The two major causes of delayed approval and nonapproval of phase III studies is poor dose selection in early studies and phase III designs that don’t utilize information from early phase studies“.

Among other things, Quo Vadis in pharmaceutical research to have an ultimate statistical instrument for the most successful drug development programs can be the combination or use of one of the following methods:

– Adaptive Design to increase the chances for success of a trial with reduced cost
– Bayesian Approaches for optimizing trial designs and development plans
– Clinical Trial Simulations to design and monitor trials

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