AllTrials – America’s Institute of Medicine says sharing data from clinical trials should “become the norm”

"A new report from the US’s Institute of Medicine says sharing of data from clinical trials is in the public interest and should be an integral part of carrying out a clinical trial. The report calls on clinical trial funders, pharmaceutical companies, patient groups, ethics committees, journals and professional bodies to make this happen. The report concludes that challenges to sharing data – privacy concerns and risks of inappropriate analyses – do not outweigh the benefits and are not barriers to sharing, but practical considerations that can be dealt with. Specific recommendations in the report include that: [1] Data sharing plans are registered with the trial registration before the trial begins [2] Summary results are published within a year of a trial’s end [3] Full data sets from a clinical trial should be shared within 18 months of the trial’s end [4] Data sharing initiatives should be overseen by independent panels of experts and the public, and should be as transparent as possible. Deborah Zarin, Director of ClinicalTrials.gov, the world’s largest clinical trial register, said: 'We were ready for a tipping point event.  This is a statement that the expectations have changed: if you’re a researcher or a research sponsor, there’s going to be an expectation that you’re going to make data available at the end of your study,' reports Vox.com. The AllTrials campaign welcomes this report and thinks its recommendations could have been stronger if they included clear pathways to implementation and calls for audits of compliance. In a few points the report unfortunately repeats some of the hyperbolic, vague statements about potential harms ‘to society’ from data sharing that have come from those who are opposed to sharing the results of their trials. Those who have raised genuine concerns have been much more specific and it quickly becomes clear in the recommendations that such risks can be addressed ..."