Clinical trial results: each patient’s participation should count

The Oncologist’s Clinical Trial Results (CTR) section was developed to be a templated, menu-driven report of a clinical trial that included the most salient facts about the study plus some discussion of the findings. This was developed as a response to a long-standing gap in publication that saw as many as half of clinical trials never published. Even among those that appeared as abstracts at the annual meeting of the American Society of Clinical Oncology, in 2016, 39% remained unpublished 4-6 years later.1 The chief goal of the CTR section is to provide a venue where a valid clinical trial can be published, whether it had completed accrual or not, and even if it was deemed a “negative study.” The trial must be IRB-approved, must have required informed consent, and must be listed on the NCI’s clinicaltrials.gov registry. Most importantly, the CTR section is committed to the concept that patients enroll in clinical trials with the expectation that their participation will “count,” that is, they will contribute to the knowledge base in oncology, and help others with cancer in the future. Most clinical cancer researchers have experience with trials being unpublished for one reason or another (eg, failure to fully accrue or a sponsor deciding to close a study). From our point of view, this has the potential for harm. Patients with cancer should not be exposed to a similar agent or combination that has already been shown to lack benefit or cause excessive toxicity.
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