On Enhancing Clinical Trial Data Sharing | Oncology | JAMA Oncology | JAMA Network

peter.suber's bookmarks 2023-10-09

Summary:

"Hopkins et al1 should be commended for providing important statistics on sharing of individual-participant data (IPD) from clinical trials by pharmaceutical sponsors, using databases designed specifically for this purpose (clinicalstudydatarequest.com,2 Vivli,3 and Yale University Open Data Access4), as well as direct requests to companies that do not use such databases....

They were granted access to the data requested for 70 of them (77%). This is undoubtedly quite an achievement compared with the situation only a decade ago, when clinical trial data were considered legal property of the sponsoring companies, and as such could not be shared with anyone beyond regulatory agencies.

However, as the authors of this study1 acknowledge, the 70 trials they obtained data from represented only a small fraction of all trials conducted in the same time period. Focusing on the small subset of 203 trials mentioned in the product labels of the approved anticancer medicines, only 91 were considered eligible for data sharing. One wonders what makes a trial ineligible for data sharing, a situation that concerns more than half of the trials...."

Link:

https://jamanetwork.com/journals/jamaoncology/article-abstract/2810123

From feeds:

Open Access Tracking Project (OATP) » peter.suber's bookmarks

Tags:

oa.new oa.data oa.clinical_trials oa.medicine oa.pharma oa.paywalled

Date tagged:

10/09/2023, 08:44

Date published:

10/09/2023, 04:44