Disclosing Clinical Trial Results: Publicity, Significance and Independence

Abstract

We shall start by making three clarifications of our position. 1 First, the US Food and Drug Administration Amendments Act of 2007 requires the public disclosure of results from completed clinical studies of approved drugs. 2 Our proposal complements this Act and extends it. Like the FDA, we believe that results from completed clinical studies of approved drugs should be made public. Our proposal focuses particularly on early stage trials such as animal studies, Phase I and early Phase II trials. Here a plausible case can be made that keeping results of these early stage clinical trials from a company's market competitors can make the difference between a company's flourishing and failing in an open market (Liao et al. 2009).Second, we argue that there is a duty to disclose adverse trial results, because there is a human right not to be placed at risk of harm without informed consent. Our view is that information about 'significant risks' must be disclosed for the purposes of informed consent (Liao et al. 2009). Appeals to a threshold of significance can be understood in at least two ways. On an objective interpretation, all risks of harm that exceed a certain degree of likelihood must be disclosed. On a subjective interpretation, all risks of harm that are material to the decision making of particular prospective participants regarding participation in clinical trials must be disclosed. We take no stand on the issue of how to interpret We would like to thank the commentators for their points, and for the opportunity to clarify our proposal.