The Patient-Centered Outcomes Research Institute approved on Friday a new policy that requires researchers to disclose the data sets and documentation used in PCORI-funded studies so others can replicate the studies to verify findings, point out flaws or advance the work.
Under the policy, PCORI will provide additional funding to certain research teams so they can place the data used in their studies in a PCORI designated repository. The data will include information collected from study participants, full protocols and statistical analysis plans. The PCORI said all personally-identifiable information will be deidentified to protect patient privacy and comply with HIPPA.
The policy is in line with ongoing efforts in the health research community to make data and methods used in studies more accessible in order to verify findings and inspire more innovation. The Institute of Medicine in 2015 called for vast changes in clinical trial data sharing, calling for the disclosure of data to be the expectation. But widespread sharing of clinical research data is continuously challenged by patient advocates concerned about privacy and competition amongst researchers. Researchers are generally incentivized in the academic community to safe guard their data because their work is rewarded through career advancement.
PCORI, a not-for-profit authorized by Congress in 2010, funds research that helps patients make more informed decisions about what treatments are right for them. The studies typically compare different treatment options for a condition to determine which is best. The studies are also used by providers, insurers, employers and policymakers.
The policy will be applied to studies with "larger research investments," said Jason Gerson, PCORI senior program officer, in an email.
Those who win PCORI and study funding can also request that other types of studies share their data. For instance, PCORI might ask that researchers share data on studies with large requests from external researchers.
"Through this data sharing policy, we're taking a major step in advancing open science," said PCORI Executive Director Dr. Joe Selby. "By supporting how others may use information generated by the studies we've funded, we're helping to enhance the quality and increase the quantity of evidence for healthcare decision-making. We're also reducing redundancy in collecting clinical data sets, which can speed research and the production of more useful evidence."
