Good progress in clinical trials transparency, but we need to do more

Launched in January 2013 by the charity Sense About Science, the AllTrials campaign has been pulling together organisations in the UK and around the world to bring greater transparency to clinical trials.  In this guest post, Stephanie Mathisen, Sense About Science Campaigns and Policy Officer, reflects on their successes over the past three years and the challenges that still lie ahead.

Clinical trials – testing treatments, diagnostic techniques or other interventions in patients – tell us what works and what doesn’t. Over the years, they have been vital for medical progress. And, of course, today’s tests and treatments for cancer – responsible for doubling survival over the past forty years – have been developed through clinical trials.

Yet the results of thousands of clinical trials have never been reported. We don’t even have a complete record of which trials have been conducted.

This means that doctors and researchers don’t have access to huge amounts of information that could – and should – be informing decisions related to our health. Not having this information from clinical trials means that patients risk not receiving the best treatment they could, and opportunities to improve medicine are being missed.

Not only does this matter to doctors and patients today – it’s also a slap in the face to the thousands of patients who take part in clinical trials every year. The failure to register and report the results of clinical trials means that the sacrifices made by those participants were made in vain.

Thankfully, attitudes towards clinical trial registration and reporting are changing.

AllTrials: Bringing transparency to clinical trials

The AllTrials campaign is calling for all clinical trials – past and present – to be registered and their results reported. So far we have the support of more than 87,000 individuals and 633 organisations – if you aren’t already one of them, please sign our petition now.

Importantly, we have some big hitters on board.

Cancer Research UK was one of the earliest organisations to sign up to our campaign, and they have provided evidence to the House of Commons Science and Technology Committee around issues affecting clinical trials in the UK.

And it’s not just charitable research funders that understand the importance of transparency for trials. One of many companies to join the campaign is the pharmaceutical giant GlaxoSmithKline (GSK). GSK joined AllTrials in February 2013, committing to register and report the results of all trials since the formation of the company in 2000.

As well as our success in mobilising the research community to take the issue of clinical trials transparency seriously, the AllTrials campaign also helped change European law to make sure that it happens.

Starting in 2018 (pdf), all new clinical drug trials will be required by law to be registered and report their results. This is progress, but there are still decades of hidden data from trials of medicines and treatments in common use today that we need access to.

Cancer trials: An example to follow

Cancer clinical trials in the UK are miles ahead of those in other disease areas – probably because of high levels of patient involvement.

Cancer patients in particular regularly participate in clinical trials, and around one in five cancer patients takes part in a clinical study. There is often an expectation among patients that their participation will lead to something beneficial; maybe not for them personally, but that it will help patients like them in the future.

As Richard Stephens, chair of the National Cancer Research Institute’s consumer liaison group, explains: “Every large-scale cancer trial in the NHS has had patient involvement in the design, approval and/or delivery phase, most of them two or three times. And most of the smaller trials have too.

“Increasingly we also help with dissemination of results and outcomes as well, because that’s why most patients become trial participants – so that the knowledge gained can benefit other patients. We expect researchers to share their findings and to be open and transparent about what they are doing and why.”

It’s a noble sentiment and, aside from a few exceptional examples, something we have managed to achieve for cancer trials in the UK.

Many of these clinical trials are funded or endorsed by Cancer Research UK and, in England, involve the NHS National Institute for Health Research Clinical Research Network (NIHR CRN) – the research arm of the Department of Health.

Crucially, any trials involving the NIHR CRN are registered and reportable, meeting high standards and included in a national portfolio of trials. Similar processes exist in Scotland, Wales and Northern Ireland.

A clearer future

These highlights of cancer clinical trial practice in the UK show that transparency is possible. Now we need this good practice – clinical trial registration and open reporting of trial results – to be replicated in other disease areas, not just in the UK but around the world, and retrospectively for all the hidden trials of medicines we use today that were conducted in the past.

We have achieved a lot in a relatively short time, but there is still so much more to do. Please join us and help enable even more patients, now and in the future, to benefit from research.

Support the AllTrials campaign by signing our petition and sharing our videos. Find out more about the campaign and how you can get involved on AllTrials.net