Data Sharing Enters a New Era

On 25 August 2022, the White House Office of Science and Technology Policy (OSTP) directed all federal agencies to develop or update their policies to ensure that peer-reviewed publications and the underlying data resulting from federal funds are freely available and publicly accessible on the day of publication (1). The OSTP action intends to stimulate innovation, restore faith in science, and renew commitment to open science. Although public availability of peer-reviewed publications may spur innovation, data sharing has greater potential but is complex and challenging. Yet, the OSTP announcement provided limited details regarding data sharing. Sharing individual-patient data can stimulate new hypotheses, confirm results of initial studies, or be used in meta-analyses (2). In addition, participants in clinical trials and prospective cohort studies consent to participate, with the expectation that, even if they do not benefit personally, information gained will benefit others. Data sharing facilitates this ethical principle (3). In the 1970s, GenBank initiated the sharing of individual-level scientific data. However, sharing data from clinical studies has been limited. To promote data sharing, the International Committee of Medical Journal Editors (ICMJE) announced in 2018 that clinical trials published in journals adhering to the ICMJE recommendations should be accompanied by a data sharing statement, but it did not mandate sharing (4, 5). A recent report assessed data sharing statements in 487 clinical trial reports in JAMA, New England Journal of Medicine, and The Lancet and found that authors of trials funded by the National Institutes of Health (NIH) were more likely to offer data sharing than were industry-funded trials (89% vs. 61%) (6). Of 89 articles stating that individualpatient data would be stored in repositories, only 17 had deposited data. Authors most often declared (43%) that the data sets were available on request. These findings suggest that much will need to change to meet OSTP’s new data sharing requirements. Reanalysis of shared data is not always intended to generate new hypotheses. Some authors of studies reporting concerns about safety of specific drugs or medical devices have received requests for data from themanufacturers of those products. Those using shared data should specifically state the intent of their analyses, including whether the intent of reanalysis is to extend, confirm, or dispute previous findings. Globally, the NIH is the largest single funder of biomedical research. Beginning in 2023, every new research grant should include a plan and budget for data sharing, and some grant announcements already indicate that data must be shared but lack detail. As the NIH develops new policies as mandated by OSTP, it should consider several issues. First, the 27 institutes and centers of the NIH should have a single approach to data sharing, which is more likely to result in consistent and effective data sharing. Second, NIH should fund centers of excellence for data sharing and training to assist investigators who desire to analyze shared data but need assistance in acquiring and analyzing data. Third, the NIH (and all federal agencies) should enforce its data sharing policy. It has been lax in enforcing its existing policies regarding sharing trial data and the posting of trial results on ClinicalTrials.gov (7). Although entities that receive federal awards or the journals that publish the results of those awards could help ensure data are shared, they have less influence than the NIH. The OSTP states that the data underlining the peerreviewed report must be made available at the time of publication, but it does not indicate when or whether the entire data set must be deposited in a publicly available repository or what happens if there is no publication. A single study often generates multiple analyses conducted over years. As federal agencies develop policies, they should address when the data must be made available regardless of whether additional analyses are anticipated and whether any results have been published. The OSTP memorandum indicates that “scientific data” should include “the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings. Such scientific data do not include laboratory notebooks, preliminary analyses, . or physical objects and materials, such as laboratory specimens, artifacts or field notes” (1). Without these additional items, the data will likely be insufficient for some meaningful analyses. Federal agencies should be clear who potential investigators should contact if additional information is needed and whether the original investigators are obligated to share that information. Sharing and analyzing data requires financial resources. The OSTP states that federal agencies “should allow researchers to include reasonable publication costs and costs associated with submission, curation, management of data, and special handling instructions as allowable expenses in all research budgets" (1). Unfortunately, this recommendation is probably not sufficient to support sharing data, particularly because of the “cap” on many federal grants. Separate funds beyond the cap should be available to adhere with this mandate. When the ICMJE announced its requirement that trial reports include a data sharing statement, 3 major concerns emerged: when should data be made available, the financial costs of data sharing, and intellectual credit for investigators who share data (6). Agency policies should clarify not only the timeline for sharing but also who bears the costs and how those who collected data should be credited in scientific reports based on those data.