Advantages of a Truly Open-Access Data-Sharing Model | NEJM
peter.suber's bookmarks 2018-10-30
"It is important to honor and reward the altruism of patients who participate in clinical trials. One way to do so is to share the data gathered in clinical trials with other researchers in a responsible and meaningful way. The cancer research community, encouraged by recommendations from the Beau Biden Cancer Moonshot, is finally moving data sharing forward from its traditional, largely unfunded, place at the end of the long list of clinical research responsibilities to center stage.
There are a number of reasons why it has it taken more than 60 years for this issue to receive the attention that it deserves. Although the incentives for doing so may differ, competitive forces lead both academic researchers and pharmaceutical companies to protect data and to use data exclusively for their purposes. This approach protects their intellectual property and also shields the primary study team and the sponsor if the release of data from a trial for analysis by others leads to conclusions or interpretations that the primary researchers deem to be misleading or erroneous. When the academic and monetary stakes are high, the chance of this situation occurring is real. Another reason for the delay is that the protection of research participants dictates that confidentiality is the highest priority, and this risk may be greater with wide sharing of the new data-dense individual data sets that are required in order to develop personalized medicine approaches. Finally, and probably most important of all, data sharing has been hampered by a lack of resources, including access to enabling data systems technology, bioinformatics expertise, and legal agreements that facilitate sharing.
The idea of data sharing is moving beyond these hurdles with a variety of models. One such model, the so-called gatekeeper model,3 uses a distinct entity to house information in a central repository, with access to specific data sets that are provided to qualified research teams on the basis of a research proposal review by an independent expert committee. Examples of this approach include ClinicalStudyDataRequest.com, a website sponsored by pharmaceutical partners, and the Vivli platform (http://vivli.org), a nonprofit corporation created to support global sharing of clinical research data. Gatekeeper models provide substantial customization and oversight for individual data requests so that contributing investigators can maintain a level of control over how their data are used. This model may appropriately address barriers to sharing for studies in which the identification of participants is a risk, such as those that involve sensitive topics, genomic data, or limited numbers of participants. This model can also offer some protection to research teams that require limitations on the use of proprietary data. A limitation of gatekeeper models is that many barriers to data use remain...."