From promises to policies: is big pharma delivering on transparency?

Abstract

As increasing numbers of pharmaceutical companies establish policies for granting third party access to their clinical trial data, the onus shifts to those ready to begin sifting through the data On 30 January, Johnson & Johnson joined a growing cast of major drug companies pledging to grant third party access to their clinical study data.1 Third party access to industry data has occurred on an ad hoc basis for decades. But unprecedented public concern over inaccessible data has led drug companies to streamline the process for granting access.2 3 Since 2012, Boehringer Ingelheim, GlaxoSmithKline, Roche, Sanofi, ViiV Healthcare, and Pfizer have established similar systems to enable access to detailed trial data including clinical study reports and electronic individual participant data. And it would seem we can only expect more announcements in the future, considering the enthusiasm expressed by the Chief Medical Officers Roundtable for a “transparent, harmonized process for access to patient-level clinical trial data.”4 (Box 1) #### Box 1. The Chief Medical Officers Roundtable (CMOR) are from 21 companies Although the details of each company’s approach differ, there seem to be more commonalities than differences in the philosophy and approach of all companies. Firstly, all companies are in favor of a “controlled access” model of data sharing under which data are not “open access”—that is, free and unrestricted—but rather limited to approved requestors. In the case of Johnson & Johnson, the Yale Open Data Access (YODA) Project team will referee requests for data. For Roche, GlaxoSmithKline, and others using the joint ClinicalStudyDataRequest.com system, the gatekeeper is a four person review panel. (GlaxoSmithKline, which established the panel, has indicated a desire …