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The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency

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Abstract

Purpose

Quality of care is strongly influenced by evidence-based medicine, a large part of which is based on results obtained from clinical trials. If trials are conducted in secret, patient safety is at risk. Several mandates—legal, editorial, financial, and ethical—have tried to influence the disclosure of clinical trials, first by encouraging registration in publicly accessible registers and, second, by calling for the publication of results. Not all these initiatives have reached high rates of compliance, but the succession of national and international events over a few years gave an important boost to information disclosure. This article provides a chronicle of the succession of the events, from the historical calls to the recent EMA policy and WHO statement, and public consultations requested by the NIH, and the HHS, which will inevitably change the international panorama. The path of these new policies is moving towards more supervised clinical research. Individual scientific institutions can also contribute, at the local level, to such an ethical endeavor as is improving research transparency, by disclosing information on the trials coordinated by their own researchers.

Results

The way is long and complex, but, if everyone contributes there could be a prompt, worldwide diffusion of the findings of clinical trials, and therefore a more possible evidenced-based medicine.

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Conflict of interest

The authors declare that they have no competing interests.

Author’s contribution

Claudia Pansieri drafted the initial manuscript, reviewed and revised the manuscript, and approved the final manuscript as submitted.

Chiara Pandolfini supervised, reviewed and revised the manuscript, and approved the final manuscript as submitted.

Maurizio Bonati conceptualized, reviewed and revised the manuscript, and approved the final manuscript as submitted.

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Authors and Affiliations

  1. Department of Public Health, Laboratory for Mother and Child Health, IRCCS-Istituto di Ricerche Farmacologiche “Mario Negri”, Via La Masa 19, 20156, Milan, Italy

    Claudia Pansieri, Chiara Pandolfini & Maurizio Bonati

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  1. Claudia Pansieri
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  2. Chiara Pandolfini
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  3. Maurizio Bonati
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Correspondence to Maurizio Bonati.

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Pansieri, C., Pandolfini, C. & Bonati, M. The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency. Eur J Clin Pharmacol 71, 1159–1164 (2015). https://doi.org/10.1007/s00228-015-1897-9

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