IOM seeking input to improve clinical trials data

The Institute of Medicine (IOM) is soliciting public comment on how best to responsibly share data from clinical trials.

The organization issued a discussion framework that includes preliminary guiding principles, defined selected data, data sharing activities and specific questions for researchers, clinical trial sponsors, patients, advocacy organizations and the general public.

“Clinical trials of medical interventions such as drugs, medical devices, procedures and behavioral interventions generate vast amounts of data, which might be shared confidentiality with government regulatory agencies or other parties but are not routinely available to other researchers or the public,” IOM said in a statement. “Sharing these data more broadly--while respecting research participants and their privacy--could facilitate new analyses, provide a deeper understanding of therapies and ultimately provide a sounder basis for clinical care.”

The discussion framework is available here and IOM requests comments by March 24. IOM expects to release a final report with findings and recommendations in late 2014.

 

Beth Walsh,

Editor

Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Trimed Popup
Trimed Popup