Female patient speaks with her doctor.

Changing the perception of early-phase cancer clinical trials

By Sharon Reynolds, National Cancer Institute

Clinical trials are an indispensable step in moving new cancer treatments from laboratory discoveries into everyday patient care. The initial human studies of new cancer treatments are called phase 1 clinical trials, and their primary goal is to find a safe dose for further testing. But a recent analysis shows that, despite their focus on safety, phase 1 trials of new cancer treatments may benefit participants more than previously thought.

In the analysis, Naoko Takebe, M.D., Ph.D., of NCI’s Cancer Therapy Evaluation Program (CTEP), and her NCI colleagues surveyed the last two decades of phase 1 clinical trials for solid tumors sponsored by CTEP. Over that period, they found, the number of trial participants whose tumors shrank or disappeared nearly doubled and the percentage of patients whose tumors stopped growing for a time also increased. The risk of death caused by a new treatment being tested, however, remained steady and very low, at less than 1%.

In this interview, Dr. Takebe talks about the findings and how they may alter the perception of these important early-phase trials. Read more …