Clinical Trial Reporting Failures Can Harm Research, Patients

Hospitals, medical schools, businesses, and even the National Institutes of Health are routinely violating a federal law requiring clinical trials to be reported to the public, a STAT investigation recently found. In response, we asked experts to offer their thoughts on why low rates of clinical trial reporting is a problem, and what can be done about it.

By Christine Laine: The timely and transparent reporting of clinical trials is of utmost importance. It has been furthered by organizations such as the International Committee of Medical Journal Editors. For example, the Committee’s trial registration policy markedly increased the number of clinical trials with prospectively documented methods in a public registry. However, the STAT investigation’s laser focus on whether the results appeared in ClinicalTrials.gov as an indicator of responsible trial reporting is troubling to me as a journal editor who oversees the peer review and publication of many clinical trials.

While the registration of results in ClinicalTrials.gov is a baby step toward responsible trial reporting, it has important shortcomings. Anyone who examines the registry will quickly see that results reported in this manner are difficult to digest and are unlikely to be meaningfully useful to patients and physicians as they make real world clinical decisions. Further, the registry allows investigators to post results that have not been vetted by peer review...