NOT-MH-14-015: Data Sharing Expectations for NIMH-funded Clinical Trials

Data Sharing Expectations for NIMH-funded Clinical Trials

Notice Number: NOT-MH-14-015

Key Dates
Release Date: June 12, 2014

Issued by
National Institutes of Health (NIH)

Purpose

Widespread data sharing by research communities adds significant value to research and accelerates the pace of discovery. The National Institute of Mental Health (NIMH) intends to establish a common informatics platform for exchanging data from clinical trials. This database will be built on the infrastructure used for the National Database for Autism Research (http://ndar.nih.gov, NDAR) and will be called the National Database for Clinical Trials Related to Mental Illness (http://ndct.nimh.nih.gov, NDCT).

Clinical Trials are defined here as prospective biomedical or behavioral research studies of human participants that are designed to answer specific questions about biomedical (drugs or devices) or behavioral interventions. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Concerns have been raised about the number of clinical trials that do not publish results in a timely fashion and on missing trials that never publish their results. Such gaps in the literature may prevent clinical decisions from being made on all of the evidence and can result in unnecessary duplication of effort. For these reasons, NIMH wants to make data from clinical trials easily available to the research community. This effort to make the data readily available is consistent with recent Office of Management and Budget and Office of Science and Technology Policy efforts to expand access to data generated using federal funds.

Awards made in response to RFA-MH-15-300, RFA-MH-15-310, RFA-MH-15-320, RFA-MH-15-325, RFA-MH-15-330, RFA-MH-15-340, and PAR-14-107 support clinical trials research. Awardees from these funding opportunity announcements (FOAs) who are collecting subject level data are strongly encouraged to deposit those data into NDCT. NIMH also supports clinical trials under a few other FOAs related to specific diseases or conditions. New clinical trials proposed via those FOAs are also strongly encouraged to deposit data into NDCT.

For clinical trials related to services research, where the primary outcomes often have to do with a health care system level intervention, NDCT will also accept relevant data and will make those results available using the Data from Papers feature that is currently available in NDAR. Applicants submitting clinical studies in response to PAR-14-165 are also strongly encouraged to submit their data to NDCT.

In order to deposit data, researchers are expected to:

Use consent forms that allow broad data sharing within the research community. Useful information about consents is available at http://ndct.nimh.nih.gov/preplanning/informed-consent/.
Create global unique identifiers (GUIDS), similar to those used for NDAR, for all of their research participants (http://ndct.nimh.nih.gov/preplanning/getting-started). NIMH will provide the software necessary to generate the GUIDs.
Work with NIMH to create data dictionaries that are relevant to their research (http://ndct.nimh.nih.gov/submit/data-dictionary).
Share results, positive and negative, specific to the cohorts and outcome measures studied (see http://ndct.nimh.nih.gov/results).

A cost model for data sharing is available at https://ndct.nimh.nih.gov/preplanning/budget. Researchers should use that model when preparing budgets for applications submitted to NIMH. Researchers who already have NIMH awards that support a clinical trial should consult with their program officer about the possibility for an administrative supplement (PA-14-077) to cover the costs of getting data ready for NDCT.

NIMH will work with funded investigators to determine the schedule for depositing data into NDCT and sharing those data with the research community as appropriate. When possible, NIMH will expect data to be deposited close to the time it is collected. Generally, this will mean that raw data are expected to be deposited every six months. In cases where data deposition every six months will be an undue burden to the investigator, NDCT will allow investigators to submit a clean data set after the final data lock. NIMH understands that for some clinical trials data received prior to the final data lock, the utility of that data may be very limited.

Depositing raw data into NDCT is a separate step from sharing those data with the research community. Because of the nature of clinical trials, it is unlikely the data will be released to the research community until after the award is complete.

NIMH understands that many of these trials will utilize a design in which the investigators are blinded to assignment and outcome. NDCT staff will ensure unmasked data deposited in the NDCT will not be released prior to the completion of the study to the extent permitted by law and applicable U.S. Department of Health and Human Services and National Institutes of Health policies.

Clinical researchers who are funded by NIMH are strongly encouraged to share their data via this new infrastructure, and to use this national resource to advance their projects. This encouragement is extended to all investigators who have clinical trials data related to mental illness, regardless of the source of support for their research.

Researchers at institutions with a Federal Wide Assurance will be able to gain access to NDCT data by submitting a data access request in accord with applicable NDCT policies (see http://ndct.nimh.nih.gov/querying/).

Researchers with technical questions or suggestions should address them to ndcthelp@mail.nih.gov. This policy is effective upon publication of this Notice.

Inquiries

Please direct all inquiries to:

Gregory K. Farber, Ph. D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0778
Email: farberg@mail.nih.gov