Trial Transparency – Expanding the Evidence
Transparency in clinical research is critical to ensure that doctors prescribe treatments based on the best-available, scientific evidence, to empower patients to make informed decisions about their care and to optimise public health resource allocation and recommendations. Transparency involves registration of clinical trials on publicly available databases 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.
Transparency was the theme of the ECRIN International Clinical Trials Day, held in Trondheim, Norway on May 21st, 2015.
At the start of 2013, the AllTrials initiative was launched and proceeded to impact the goal of registration and reporting of all clinical trials. Trish Groves, Deputy editor, BMJ and Editor in chief, BMJ Open, explained the story and the success of the AllTrials initiative and gave the perspective of scientific journals.
The Institute of Medicine was established by the US National Academy of Science to examine policies that impact public health. Rita Banzi from the Mario Negri Institute for Pharmacological Research, Milan, Italy reviewed the Institute of Medicine's 2015 report on transparency.
The Cochrane Collaboration works to produce high-quality systematic reviews and other synthesized research evidence about the effectiveness of healthcare. Toby Lasserson, a Senior Editor, explained the Cochrane Collaboration's views on clinical research transparency.
Pharmaceutical companies have varied in their approaches to sharing trial information. Andy Powrie-Smith of the European Federation of Pharmaceutical Industries and Associations presented an overview of the industry's views.
The medical device industry was represented by Gabriela Soskuty, Vice President Government Affairs at B. Braun Melsungen AG. She talked about development and transparency in medical device research outlining some key differences compared with drug development.
The Nordic Trial Alliance Working Group on Transparency and Registration have published best practice recommendations that balance the interests of the public, patients, regulatory authorities, researchers and industry. Kristjan Erlendsson from Landspitali University Hospital in Reykjavik talked about the report.
ECRIN requires the following transparency criteria for supported trials:
- Commitment to register the trial in a public register before inclusion of the first participant (for example on www.clinicaltrials.gov)
- 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
Silvio Garattini from the Mario Negri Institute, head of the ECRIN Scientific Board, described ECRIN's experiences with transparency.