Can Changing Trial Design Speed Drug Testing?
Among the most significant hurdles in the design of a Phase III trial is finding an outcome measure that can quickly show whether a drug is working. Outcome measures are what researchers measure, such as prolonged survival or slower loss of strength. There are difficulties with both of these outcome measures. Strength fluctuates from month to month, so that only over many months can a clear effect of a drug be seen (or ruled out). Survival also requires very long trials. Researchers would like to be able to conduct much shorter trials, but shorter trials using these outcome measures must enroll many more patients, greatly increasing costs. At the conference, researchers discussed at length two strategies that might help solve this problem. Changing the design of Phase II trials could require fewer patients while still providing valuable information. And “biomarkers” that reliably track disease progression without short-term fluctuations would allow shorter trials. The trial design chan
