Bioethics Blogs

Honoring Our Promise: Clinical Trial Data Sharing

Clinical Trials Data Sharing Word CloudWhen people enroll in clinical trials to test new drugs, devices, or other interventions, they’re often informed that such research may not benefit them directly. But they’re also told what’s learned in those clinical trials may help others, both now and in the future. To honor these participants’ selfless commitment to advancing biomedical science, researchers have an ethical obligation to share the results of clinical trials in a swift and transparent manner.

But that’s not the only reason why sharing data from clinical trials is so important. Prompt dissemination of clinical trial results is essential for guiding future research. Furthermore, resources can be wasted and people may even stand to be harmed if the results of clinical trials are not fully disclosed in a timely manner. Without access to complete information about previous clinical trials—including data that are negative or inconclusive, researchers may launch similar studies that put participants at needless risk or expose them to ineffective interventions. And, if conclusions are distorted by failure to report results, incomplete knowledge can eventually make its way into clinical guidelines and, thereby, affect the care of a great many patients [1].

Unfortunately, the timely public reporting of results has not been consistent across the clinical trials enterprise. For example, a recent analysis of 400 U.S. clinical trials [2] found that even four years after the trials had been completed, nearly 30% had failed to share results by publishing in a scientific journal or reporting in ClinicalTrials.gov, a public database maintained by NIH.

Today, the Department of Health and Human Services (HHS) proposed a rule to require public sharing of key results—the summary data—from certain clinical trials of drugs and devices regulated by the Food and Drug Administration (FDA).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.