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Going further to make all clinical trials public

by Guest Author on 8 Jun 2018

By backing the AllTrials campaign we commit to making all clinical research – both positive and negative – publicly available. We’ve taken the lead in the UK by helping our researchers achieve this goal. But there’s still more funders can do, as Síle Lane, Head of international campaigns and policy at Sense about Science, explains.

Síle Lane

The MRC was one of the first organisations to sign up to the AllTrials campaign which is now supported by almost 800 organisations worldwide. AllTrials is the global campaign for all clinical trials to be registered and results reported.

With backing from organisations like the MRC we have been able to put clinical trial transparency on agendas at the highest levels including the World Health Organisation, the UN, national governments and the European Parliament. New laws mandating transparency have been written and serious discussions have started in research organisations and professional societies about new rules they should adopt to support more transparency.

A public commitment to transparency

So what can funders like the MRC do to help their researchers comply with these new rules? The obligations on researchers to register and report trials are moral, ethical, professional and legal. To help their funded researchers understand what they have to do, funders should have a policy and a public commitment to compliance with these obligations. Most don’t. But the MRC does.

In May 2017 the WHO released a statement on clinical research funders’ policies to urge the majority to do better. The statement committed signatories to writing and implementing a policy to ensure all clinical trials they fund are registered, all results from them are reported and to devising a way to monitor compliance with this policy. Twenty-one funders from around the world have signed up now, including the Bill and Melinda Gates Foundation and Médecins sans Frontière. The MRC was one of the very first to sign up.

One year on, AllTrials is going to review the policies of the 14 funders who joined last May to check if they have kept their commitments. We’ll have the results of that very soon. Given that the MRC’s existing policy already commits researchers to register and report funded clinical trials, we’re sure the MRC will again be one of the organisations leading the way.

Blazing the trial

We know the MRC’s policy is among the strongest in the world because of research published last month (in JAMA, so it’s behind a paywall). This audit of the 18 largest global philanthropic and public funders found only two have a policy that hits the gold standard. The MRC was one of these (the other is Germany’s research funding organisation Deutsche Forschungsgemeinscaft).

The MRC’s policy requires researchers to register trials, report summary results from trials and be prepared to share the underlying data. And they support researchers with the costs of doing this. The MRC should be proud that the council has taken a lead in the UK on working to reach this standard.

Going further

Things are continually changing though. The National Institutes of Health (NIH) – the largest funder of medical research in the world – has just said that it won’t grant funds unless it can verify that the applicant registers and reports their trials. Researchers’ past reporting performance is now going to impact on whether they get funding for new trials. This is a first for clinical trial funders and I think it has the potential to make a massive difference in getting more old trials reported.

Research funding organisations around the world are looking to each other as they investigate what they can do to respond to researchers’ calls to better help them fulfil their obligations to report all trials. The step the NIH took, to make a review of past reporting performance part of the assessment for new research, is particularly significant.

The NIH is by far the largest non-commercial funder of clinical trials in the world and so when it changes, it changes the baseline for what a funder could do. We hope it will show organisations who are already doing well – like the MRC – that there is still further they can go. However, right now, the MRC is showing us all how to absorb the new rules on clinical trial transparency into the way it works, and will help you, its researchers, do that too.

Sense about Science is the UK charity that campaigns on the use and misuse of evidence in public life and launched the AllTrials campaign for clinical trial transparency in 2013.

For more information:

Read about recent MRC initiatives in data-sharing from clinical trials on our blog

Find the MRC policy and recent MRC review of clinical trials transparency on our website

Access MRC evidence submitted to the House of Commons Research Integrity Inquiry in January 2018

If you have specific questions, contact Rachel Knowles.

Comments

About time… 🙂 – Money & available data are Tooo Precious to be wasted… 🙂

author avatar by Alan Christopher Creaser, on 11-Jun-2018 16:11:24

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