Novel Trial Design Aims To Speed Drug Development

Scientists have gained important insights into the biological underpinnings of cancer, but this knowledge has not led to a jump in the number of therapies approved for clinical use. One possible reason for the slower than expected progress is the time required for clinical testing with current trial designs.

With that issue in mind, Mahesh Parmar, Ph.D., of the Medical Research Council Clinical Trials Unit in London and colleagues modified standard clinical trial methodology so that multiple therapies or combinations can be compared in a single trial. The new design incorporates standard phase II and phase III goals into one multi-phase trial and requires fewer patients than standard trials.

In the commentary, Parmar and colleagues discuss the need for fresh approaches to clinical trials, describe the new trial design in detail, and provide examples of on-going trials that use the multi-arm trial approach. "With three real examples, we hope that we have shown that such trials are feasible and can lead to major improvements in speed and decision making," the authors write.