]), contact details for IPD sharing inquiries, and whether trial completion was a criterion for data sharing .Beginning August 1, 2021, the IPD sharing eligibility of each trial was confirmed by either identification of a public listing of the trial as eligible for IPD sharing or receipt of a positive response to a standardized inquiry directed to the trial sponsor . Ineligibility for IPD sharing was confirmed by a negative response to the inquiry .
Of the 49 pharmaceutical companies audited, 24 were PhRMA/EFPIA members, and 28 had a publicly available IPD sharing policy; these companies sponsored 261 and 273 of the trials audited, respectively. Nineteen pharmaceutical companies that sponsored 211 trials shared IPD through an external platform , 9 companies shared through an internal company process, and 21 companies had no defined process to share IPD.
Eighteen of the top 20 pharmaceutical companies by global revenue sponsored trials in the study sample. These 18 companies owned 81 of the audited medicines for which results from 245 trials were summarized in their product labels. In addition, for the top 10 anticancer medicines by global revenue, results from 89 trials were summarized in their respective product labels.
Of the 304 industry-sponsored trials audited, the eligibility for IPD sharing status was publicly available for 64 trials . The remaining 240 trials required an inquiry to the sponsor to establish whether the trial was eligible for data sharing. The median response time to these inquiries was 42 days . For 9 trials sponsored by 8 different pharmaceutical companies , no response to the eligibility inquiries was received.