The NYT recently published a great article entitled Lack of Study Volunteers May Hobble Cancer Fight, which covers the very real dilemma patients and their doctors face when newly diagnosed with cancer – whether or not participate in a clinical trial. The competition for patients is increasing fierce and “real life” considerations such as drive time, opportunity cost, convenience play a very important role. According to the article …
There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov, a trials registry. But many will be abandoned along the way. More than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result, Dr. Ramsey and his colleague John Scoggins reported in a recent review in The Oncologist.
Only one study in five even publishes its results, Dr. Ramsey and Dr. Scoggins found.
And, of the unpublished studies, “a significant percentage” probably ended uncompleted because they could not recruit enough patients, noted Dr. Gregory A. Curt and Dr. Bruce A. Chabner, editors of the journal The Oncologist, in an editorial on Dr. Ramsey’s and Dr. Scoggins’s paper. “Which potential statistic is the sadder, the low publication rate” or, Drs. Curt and Chabner wrote in The Oncologist, the meager number of patients who enroll?
While the article illustrates the very real decisions patients and their doctors must make (in determining if they will participate in a trial), I can’t help but think we’ve been talking about these issue for too long without much progress. You see, life can’t be controlled, convenience and financial considerations must be dealt with in a meaningful way, if we’re to encourage more patients and doctors to advance the science of cancer care.
Designing trials that consider such issues as drive time, doctor opportunity costs, and other real-world factors must be part of the equation. While pure science is the objective, it’s increasingly unrealistic to operationalize clinical trials in a “science” vacuum, but new approaches are promising so let’s encourage and support new thinking to improve outcomes.