Honoring Our Promise: Clinical Trial Data Sharing

Posted on November 19th, 2014 by Drs. Kathy L. Hudson and Francis S. Collins

When 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). While such a mandate has been in place for several years [3], the proposed rule aims to clarify the requirements [4]. Summary data would include: baseline characteristics of participants, primary and secondary outcome results, and information about adverse events. With a few exceptions, such results must be submitted to ClinicalTrials.gov within one year of the time when the trial completes collection of primary outcome data.

But we at NIH are proposing to go one step further to address this important issue. Today, NIH released a draft policy for public comment to apply these data reporting requirements to all interventional clinical trials that it funds [5]. We are committed to working with NIH-supported researchers and institutions to ensure the new responsibilities in this proposed policy are understood and any unanticipated obstacles are removed.

What all this really comes down to is trust. Clinical trial participants trust that the data they provide will be used by biomedical science to advance the health of many. Researchers seek to add to the body of biomedical knowledge and can respect this commitment by promptly sharing clinical trial data.

There is also the important matter of public trust. American taxpayers trust NIH to be a good steward of their investment—and one way we can do that is to ensure that results of all our clinical trials are shared with the worldwide scientific community in an open and efficient manner. Data sharing is essential to turn even more scientific discoveries into better health at an even faster pace!

References:

1. Sharing and reporting results of clinical trials. Hudson KL and Collins FS. JAMA. 2014.

2. How frequently do the results from completed US clinical trials enter the public domain?—A statistical analysis of the ClinicalTrials.gov database. Saito H and Gill CJ. PloS One. 2014 Jul 15; 9(7).

3. Food and Drug Administration Amendments Act of 2007 (FDAAA) (42 U.S.C. 282(j)).

4. Notice of Proposed Rulemaking, Clinical Trials Registration and Results Submission. Department of Health and Human Services. 2014 19 November.

5. NIH Request for Public Comments on the Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. NIH Guide. 2014 19 November.

Links:

HHS and NIH take steps to enhance transparency of clinical trial results. News Release (NIH/HHS). 2014 19 November.

ClinicalTrials.gov (National Library of Medicine/NIH)

Rock Talk blog (Office of Extramural Research/NIH)

Note: Kathy L. Hudson, Ph.D., is NIH’s Deputy Director for Science, Outreach, and Policy.