Journal of Law, Medicine and Ethics 42 (2):244-262 (2014)

Abstract
Efforts to ensure greater transparency in the regulation of “drugs” are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive or negative —should also be open to outside scrutiny provided they are final in nature.
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DOI 10.1111/jlme.12139
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References found in this work BETA

Transparency: The Key to Better Governance?Christopher Hood & David Heald - unknown - Proceedings of the British Academy 135.
Pharmaceutical Knowledge Governance: A Human Rights Perspective.Trudo Lemmens - 2013 - Journal of Law, Medicine and Ethics 41 (1):163-184.
Pharmaceutical Knowledge Governance: A Human Rights Perspective.Trudo Lemmens - 2013 - Journal of Law, Medicine and Ethics 41 (1):163-184.

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