Adaptive Approach to Clinical Trials

The design of clinical trials and the volume of pharmacogenomics data being generated present challenges to the development and success of future treatment options.

Irwin W. Tischler, DO, suggests that an adaptive approach to clinical trial design can accelerate the development of new agents. He explains that having the capability to modify the design of a trial based upon preliminary results, on an as-you-go basis, may help speed the clinical trial process. For example, based on initial data, the dose of a drug used might be changed during the course of the trial, or the patient population might be modified to include patients who would benefit most.

Dr Tischler adds that pharmacogenetic testing is associated with financial challenges. He explains that testing often involves more than 200 genetic markers; however, only 20 genetic markers are presently actionable. Thus, large amounts of money are being invested on information that is not clinically relevant.

Watch our related Peer Exchange, Oncology Stakeholder Summit 2014: Evidence-Based Decisions to Improve Quality and Regulate Costs