Transparency in clinical research involves registration of clinical trials on publicly available databases (e.g., www.clinicaltrials.gov), accessibility of patient data for subsequent analysis, and publication of results irrespective of the trial outcome. In addition, for full transparency patient-level data should be accessible, enabling reanalysis, secondary analysis, group analysis and patient-level meta analysis.
Having transparent results aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best-available scientific evidence. Evidence-based public health decisions and strategies ensure, in turn, an optimal allocation of public health resources and, ideally, better patient outcomes.
While medical professionals and policymakers need the results of clinical trials to make decisions about which treatment is best, not all registered trials publish their findings. It is estimated that the results of half of all completed clinical trials have never been published, and trials with positive results are twice as likely to be published (source).
How ECRIN Supports Transparency
ECRIN requires the following transparency criteria for the trials it supported trials:
- Commitment to register the trial in a public register before inclusion of the first participant
- Commitment to publish results irrespective of findings
- Commitment to make raw anonymised data sets available to the scientific community upon request to the sponsor or principal investigator one year after the trial is completed (last follow- up of the last patient) or, for registration trials, when registration is completed or the development is discontinued
Transparency was the theme of the ECRIN International Clinical Trials Day, held in Trondheim, Norway on May 21st, 2015. Click on the links below to see videos of presentations from diverse stakeholders.
- Rita Banzi from the Mario Negri Institute for Pharmacological Research, reviews the Institute of Medicine's 2015 report on transparency
- Kristjan Erlendsson, associate professor of medical education, associate dean of education, University of Iceland Medical Faculty, discusses how to improve regulation and transparency in Nordic clinical research
- Silvio Garattini from the Mario Negri Institute, head of the ECRIN Scientific Board, on ECRIN's experiences with transparency
- Trish Groves, deputy editor, BMJ, and editor in chief, BMJ Open, explains the story and the success of the AllTrials initiative and gives the perspective of scientific journals
- Toby Lasseron, senior editor, Cochrane, presents Cochrane's view on present and future transparency in clinical research
- Andy Powrie-Smith, director – team leader, European Federation of Pharmaceutical Industries and Associations, presents the views of the pharmaceutical industry on transparency
- Gabriela Soskuty, vice president government affairs at B. Braun Melsungen AG, talks about transparency of clinical evidence in medical devices