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Symposium X: Patients can change data-sharing landscape

There is a vast amount of underutilized clinical trial data in medical research. Speakers at a symposium sponsored by the U.S. Food and Drug Administration and the non-profit Project Data Sphere® focused on why accessing this resource is so challenging and how obstacles can be overcome.

More than 180 attendees representing Industry, Government, Non-Profits, and Academic Institutions along with members from healthcare providers, analytics companies, and patients, made it clear that clinical trial data sharing is a topic of interest.

Technology is not the limiting factor for broad sharing said keynote speaker, Dr. Robert Califf, President Joe Biden’s nominee to lead the Food and Drug Administration. Instead, he said it is the way we think about and put guardrails around data that is limiting.

Dr. David Fajgenbaum, Assistant Professor of Medicine at the University of Pennsylvania, shared that patient advocates are well positioned to find paths to overcome these barriers, serving as unbiased, relentless drivers motivated by progress against disease.

Sue Sherman, Executive Director and Chief Executive Officer of the LAM (lymphangioleiomyomatosis) Foundation, offered examples of success fueled by patients in partnership with NIH, clinical researchers, and the FDA. Together they have made remarkable progress in treating this rare disease, including the first FDA-approved treatment for LAM, published treatment guidelines, development of a blood-based diagnostic marker reducing the need for biopsy, enrollment of 3,300 patients in a US patient database, and $29 million raised for research, education, and patient support.

Industry representatives offered some practical suggestions of their own and Dr. Ned Sharpless, Director of the National Cancer Institute, challenged the audience to think creatively, and find ways to actively work directly with patients to drive faster results and establish practices that allow for the maximum capacity to share.

“We have an obligation to optimize the value of data collected from patients to benefit future patients,” said Bill Louv, President of Project Data Sphere®.  “Several successes were described during the symposium, and they give us confidence and inspiration that we can do more.  … Through our collaborations, PDS is committed to catalyze improvements in policies, procedures, standards, and infrastructure to optimize data sharing.”

Here is an on-demand replay of the event. 

Here is an executive summary of the event.