The ethics of reporting all the results of clinical trials

Abstract

Introduction or background: The terms 'publication bias' and 'reporting bias' describe aspects of a phenomenon by which data from trials are not publicized, and so remain inaccessible. This may generate a false impression about the world; but those facts may have important implications for clinical decisions. Thus, the bias may leave patients worse off than they might be.

Sources of data: Published journal articles.

Areas of agreement: There is general agreement that the phenomenon happens, and that to the extent that it happens, it is undesirable for moral rather than simply epistemic reasons.

Growing points: There is a growing demand across the board for data to be better publicized.

Areas timely for developing research: There is room for further work on how protocols requiring that data be publicized might be enforced; should it be statutory, or non-statutory? Who should decide what should be made public? There is also room for work on what it is necessary to share, and on whether and how IP law should be reformed.

Keywords: AllTrials; clinical trials; data-sharing; publication bias; reporting bias; research ethics.