The Institute of Medicine (IOM) recently released a report on Sharing Clinical Trial Data: Maximizing Benefits and Minimizing Risks. The overall message was that sharing clinical trial data and specifically patient data represents a major opportunity for improved healthcare and new drug development. Following the release of this report a panel of key opinion leaders was assembled including the director of ClinicalTrials.gov.; Deborah A Zarin.
Dr. Zarin pointed out that sharing of data is a huge change in culture for the pharmaceutical industry as most R&D organizations covet the data that they generate. The IOM report lays out basic recommendations for when to share and what to share as shown below:
Dr. Zarin also outlined the potential role that ClinicalTrials.gov can provide to standardize and provide a context for available information including a listing of all trials on a topic and documentation of what information is available for each trial which would avoid disclosure bias.
ClinicalTrials.gov has evolved dramatically over the past 8 years and will continue to be the anchor point for trial disclosure and transparency.