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3.3.4 Transparency and Publication

Recommendation 3.3.4.1: Sponsors, researchers, and clinical investigators should publish preclinical studies in full and in ways that enable an independent observer to interpret the strength of the evidence supporting the conclusions.

The publication of preclinical studies serves many ends. It enables peer review of clinical research programs, thus enhancing risk/benefit ratios in trials, respects the use of animals and reagents by disseminating findings from studies, enables more sophisticated interpretation of clinical trial results, and makes possible the evaluation of preclinical models and assays, thus promoting a more effective research enterprise. However, many studies show biased patterns of preclinical publication (Sena et al., 2010; Tsilidis et al., 2013). Preclinical studies—at least those that are aimed at confirming the hypotheses motivating a development program—should be reported in full regardless of whether they confirm, disconfirm, or are inconclusive with respect to the hypothesis they are testing. These guidelines recognize that publication may reveal commercially sensitive information and therefore acknowledge that a reasonable delay is permissible to secure appropriate protection of intellectual property. Nevertheless, preclinical studies supporting a trial should be published before the first report of trials. Animal studies should be published according to well-recognized standards, such as the ARRIVE (Animal Research: Reporting In Vivo Experiments) criteria, that have been endorsed by leading biomedical journals (Percie du Sert et al., 2020).

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