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:

  • Data sharing plans are registered with the trial registration before the trial begins
  • Summary results are published within a year of a trial’s end
  • Full data sets from a clinical trial should be shared within 18 months of the trial’s end
  • 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.

Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign, said:

“Data sharing is vital if we are to make truly informed decisions with patients about which treatment is best for them. It helps us spot when trials have been misleadingly or incorrectly analysed. It helps prevent trials being repeated unnecessarily. It allows us to combine all the information, from large numbers of studies, and so produce the clearest possible picture of which treatments work best overall. It also helps us identify which treatment will work best for each individual patient.

“The risks of data sharing have been greatly overstated, by a dwindling number of senior figures in pharma who think that secrecy is necessary to protect their work, and their reputation. In reality, these people have inflicted enormous avoidable harm on the reputation of their industry, and on medicine as a whole. Modern medicine is built on clear information, transparency, and informed patients. There is no way back.”

Tracey Brown, Managing Director, Sense About Science, co-founding organisation, AllTrials campaign:

“No one now has any excuse not to commit to sharing clinical trial data. This report straightforwardly addresses specific challenges to data sharing with specific recommendations. It confirms what some companies, research institutions, funders and regulators are already doing. The only people who are still saying that challenges to data sharing make it impossible are the ones who are not sharing results.”

Professor Carl Heneghan, Director, Centre for Evidence Based Medicine, Oxford and co-founder AllTrials campaign: 

“This report is welcomed as it clearly indicates that sharing data benefits science and patients alike and should be the norm. When the Institute of Medicine states there are ‘compelling justifications for sharing clinical trial data to benefit society and future patients,’ you would expect robust recommendations too. But some of its recommendations are disappointingly weak. Providing metrics which are actionable, accessible and auditable is the key to effective data sharing. What is omitted from this report is a recommendation that trial sponsors and institutes should regularly audit their compliance with data sharing, which could provide a notable measure of quality of responsible sharing of clinical trial data.

The IOM is right to point out that the ‘the costs of data sharing are borne by a small subset of sponsors, funders, and clinical trialists.’ There now needs to be concerted efforts to make data sharing affordable and feasible.”

Harlan Krumholz, Director of the YODA project told Forbes:

“It is gratifying to see the IOM come out strongly for data sharing. At this point they are codifying what is an emerging consensus and unstoppable growing momentum for open science in medical research. How we ever developed a culture that favored researchers over society is a good question – but the good news now is that we are firmly on our a way to a better, more responsible scientific culture. It is no longer just the voices of those outside the power structures that are calling for change.”

The Institute of Medicine (IOM) is an independent, non-profit, US-based organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public.

Coverage

Sharing individual patient data from clinical trials The New England Journal of Medicine

Sharing clinical trial data: Maximizing benefits, minimizing risk JAMA

Drug researchers hide thousands of negative studies. A new campaign is trying to change that. Vox.com

Institute of Medicine urges broader sharing of clinical trial data Wall Street Journal Pharmalot

Buried clinical trial data: The dam is about to burst Forbes

Why transparency and data sharing in clinical trials matter Forbes

Clinical data sharing ‘should be the norm’, says IoM PMLiVE

Institute of Medicine adds voice to calls for trial transparency Outsourcing-Pharma.com

Sharing trial data should be ‘expected norm’ says US think-tank Pharmafile