Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3334 (Published 26 July 2017)Cite this as: BMJ 2017;358:j3334

• Individual patient data (IPD) is the raw data collected during a clinical trial, with detailed information on each individual participant. As such it presents important opportunities for research—for example, by allowing third parties to verify trialists’ initial analyses; permitting meta-analysis of pooled IPD for more accurate point estimates of benefits; giving greater power for subgroup analyses; and allowing new hypotheses to be explored in existing data, including on abandoned products and treatments.262728 However, it also presents a risk of re-identification of pseudonymised participants. Because of this, IPD is not generally posted in public but shared through various controlled access mechanisms, as with other forms of rich electronic health record data used by epidemiologists.

"22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses)"