Continued Access to Investigational Medicinal Products for Clinical Trial Participants—An Industry Approach

ABSTRACT: Abstract: In the conduct of clinical trials for pharmaceutical research, access to investigational medicines following clinical trials is often necessary for the continued health and well-being of the trial participants; it is an ethical obligation under some circumstances, as outlined in the Declaration of Helsinki 2013 Article 34. This obligation becomes particularly important in lower-income countries, where access to medical care may be limited. Although there is agreement among global research and bioethics communities that continued access should be provided with prospectively defined parameters and procedures, the process is complex, as many responsible parties and complicated logistics are involved. Roche Pharmaceuticals developed and publicly posted the company’s policy regarding

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PROVIDER: S-EPMC6317109 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature