Early Ends to Positive Oncology Trials? Not Always Good News.

According to a study published recently in the Annals of Oncology, there is a growing tendency for pharmaceutical manufacturers and clinical investigators to call a premature halt to cancer drug trials the moment a benefit appears, in order to beat their competitors to market.

The Italian group analyzed 25 randomized controlled trials of oncology drugs between 1997 and 2007 — all of which were stopped early after showing some patient benefits. More than half of the trials were stopped in the past three years. Five had enrolled less than 40% of the target number of patients. The researchers warn that “the risk of overestimating treatment effects increases markedly when the sample is small.”

Paul S. Mueller, MD, an associate professor of medicine at the Mayo Clinic— who wasn’t involved with the Annals of Oncology study — concurs, saying, “Decisions are being made on some fairly shaky evidence.”

We agree with Dr. Mueller’s conclusion: “Trials should be carried out long enough in order to obtain data about outcomes important to doctors and patients.” It’s not just good public relations; it’s good public health.