Advantages of a Truly Open-Access Data-Sharing Model — NEJM

"Multi-institutional randomized clinical trials have been a feature of oncology research in the United States since the 1950s. Since that time, cancer-treatment trials have been continuously funded by the National Cancer Institute (NCI) through a program that has evolved to become the National Clinical Trials Network (NCTN). Currently, approximately 19,000 patients with cancer participate in NCTN clinical trials each year. Approximately 70,000 additional patients with cancer are enrolled each year in treatment trials sponsored by the pharmaceutical industry.1,2

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."