Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages.

ABSTRACT:

Importance

The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized.

Objective

To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials.

Design, setting, and participants

From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. Thi

SUBMITTER: Hopkins AM 

PROVIDER: S-EPMC10557028 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature