What Are Some Challenges Surrounding The Operationalization Of The Data-Sharing Mandate Posed By The International Committee Of Medical Journal Editors (ICMJE)?

A: BEYOND OWNERSHIP, THERE ARE OTHER QUESTIONS TO CONSIDER. For example, current consent forms address who will see the data and what will be done with it. To open up data use, consents would need to be modified. However, what if patients do not agree? Does that exclude them from the study, or would accommodations need to be made to remove their data? The language on data ownership and use is already challenging to agree upon. So what happens regarding site contracts and compensation agreements already in place? Would these agreements need to be retroactively amended? What if the shared data led to a new discovery? How does that finding go back to the data originators? Further, most clinical trial data is tightly tied to specific objectives. Without trial context information, it may be difficult to adequately interpret.

MARY ROSE KELLER
Mary Rose is VP of clinical operations at Heron Therapeutics. She has 30+ years of industry experience in clinical development strategy and execution of global Phase 1 to 4 clinical trials.