Move clinical trial data sharing from an option to an imperative

Data from clinical trials have long been locked away, some in this principal investigator’s computer bank, some in that pharmaceutical company’s cloud. For years we have been talking about opening up those vaults and freeing these data. The key has finally turned: Data sharing is becoming the new reality.

From Jan. 1, 2019, onward, the world’s leading medical journals, including the New England Journal of Medicine, the Lancet, Annals of Internal Medicine, BMJ, and thousands more require authors to disclose whether and how they plan to share deidentified raw data from individual participants in their clinical trials. What’s more, researchers wishing to publish in these journals must declare their data-sharing plans in a public registry, such as ClinicalTrials.gov.

It’s a radical departure from where we’ve been. In my former life conducting trials as a scientist in industry and for the National Institutes of Health, when I’d log onto ClinicalTrials.gov to register a new trial, I didn’t have to give a second thought to if or how I’d be sharing data from the trial. Now all researchers need to think about that from the very beginning, even before the first trial participant is enrolled.

To be clear, these new journal requirements do not require authors to share their data, so even with this new policy researchers might be tempted not to do so. That’s understandable. Clinical trials are becoming increasingly complex, costly, and time-consuming. Competition among researchers, whether they are in the biopharma industry or in academia, is fiercer than ever.

But there are rewards for sharing data. By building upon each other’s work, we can move faster toward insights for diseases such as asthma, cancer, dementia, diabetes, heart disease, and more. That’s good for science and patients.

There are also rewards for the researchers who share data. They can be more widely recognized for their hard work. Those who share data receive more citations from other researchers. It’s a reward system that builds on itself: As the number of papers that reuse a data set grows, the more citations a researcher receives. This takes on even more significance with the International Committee of Medical Journal Editors requirements, as editors have indicated they “may take into consideration data sharing statements when making editorial decisions.” What’s more, a growing number of funders — from government to philanthropy — require grantees to share data. With more grants and more publications can come the golden prize of tenure for academics.

Even more important, sharing clinical trial data honors the people who volunteer for them. They put themselves at risk, give up precious time — sometimes years — and must endure multiple medical exams, blood draws, scans, and more.

All too often I am met with surprise when I tell patient groups that clinical trials are designed to answer just a single fundamental question. They rightfully expect that their data will live on and be used to help solve future problems. Now this expectation could become reality.

Over the last few years, the culture in the pharmaceutical industry has begun to shift toward more transparent sharing of data. Academic investigators have also started to step forward to share their clinical trial data. Now, with the new journal requirements, these decisions are out there for the world to see, shared on a public register. I believe this public declaration will accelerate data sharing.

As it becomes easier and more fruitful than ever before to share data, researchers are starting to awaken to this new reality. Several platforms are now available to help researchers share patient-level data. These platforms are tailored to address researchers’ concerns — whether that’s fear of losing credit for their work or losing control of their data — and resolve practical worries about how to actually share it. (Full disclosure: I work for a nonprofit institution that manages such a platform.)

I hope that 2019 is a landmark year for data sharing — a year when investigators and researchers who run clinical trials create data-sharing plans and make them public. This move to more collaborative science won’t just accelerate medicine. It is an ethical imperative and our responsibility to patients worldwide.

Rebecca Li is executive director of Vivli, an independent, nonprofit organization that has developed a global data-sharing and analytics platform. She is also a faculty member at the Center for Bioethics at the Harvard Medical School and a senior advisor at the MRCT Center of Brigham and Women’s Hospital and Harvard.