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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1159-1164
Number of pages6
JournalEuropean Journal of Clinical Pharmacology
Volume71
Issue number10
DOIs
Publication statusPublished - Aug 5 2015

Keywords

  • Clinical trials as topic/legislation and jurisprudence
  • Government regulation
  • Publication bias
  • Registries

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

Fingerprint Dive into the research topics of 'The evolution in registration of clinical trials: A chronicle of the historical calls and current initiatives promoting transparency'. Together they form a unique fingerprint.

Cite this