A new strong and detailed report, written by Nordic clinical trial experts, sets a high international standard for clinical trial transparency and sets out how to make it a reality. The report from the Nordic Trial Alliance Working Group on Transparency and Registration aims to make the Nordic countries world leaders in clinical trial transparency. It says academic institutions and politicians need to create clear laws, regulations and guidelines to ensure:
- registration of all trials and retrospective registration of unregistered trials,
- reporting of summary results from all trials within one year of the end of the trial and retrospective reporting of unreported trials,
- publication of full trial reports at the same time as the summary results and
- sharing of depersonalised individual patient data.
Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials campaign:
Everyone should welcome this collective initiative by leading experts from all the Nordic countries – Denmark, Finland, Iceland, Norway and Sweden – acting together to demand greater transparency in clinical trials. Their recommendations set a high standard for their governments and institutions to adopt and for other regions to reach for.
Christian Gluud, Head of Department at Copenhagen Trial Unit and Chair of the Nordic Trial Alliance Working Group on Transparency and Registration:
Discussions have been ongoing on transparency and data sharing of clinical research data for more than 30 years and most of the discussions have talked about it as something relevant for a distant future. The Nordic Trial Alliance report demonstrates that the future is here now – we just need to act! As so often before, a little help in the form of laws, regulations and statements from governments, regions, and international organisations like the WHO can stop the unhealthy current practice. But investigators and industry can already start acting today. Anything else would be unethical.
This report adds to the growing chorus of influential bodies calling for an end to secrecy in clinical trial results. Last week, the WHO said that results from all trials, including past trials, should be made available and in January the Institute of Medicine in the USA said sharing data from clinical trials should “become the norm.”
It will be up to companies, research groups, funders, regulators and legislators to make these recommendations a reality. How will your organisation lead the way in driving up standards and ensuring the results of past trials are uncovered?