Ignorance is no excuse – universities must report clinical trials

We heard recently that vice-chancellors of UK universities face being called into Parliament to explain themselves if their institution has not reported results from clinical trials.

This happened when the House of Commons Science and Technology Select Committee announced that it would monitor universities’ clinical trial reporting rates over the next six months and if universities did not show an improvement, they may call the vice-chancellors to explain why not.

Reporting clinical trial results is the right thing to do – ethically, morally and legally. But in the UK, university researchers have failed to report almost 60 per cent of results to the EU register, failing to follow their legal obligations.

This is despite the fact that there is a global, overarching ethical obligation on all researchers to report results from clinical research. Governments agree that it is vital for patients, doctors and society that clinical trial results are reported, while legislation in the EU and US stipulates that results must be reported to the relevant registers within a given time frame.

However, analysis by the AllTrials campaign, an initiative calling for all past and present clinical trials to be registered and their results reported, reveals that 59.7 per cent of all trials from UK universities currently identified as due to report results to the EU register, have not been. 

What’s more, when we launched our EU trials tracker tool, which was developed by EBM DataLab at Oxford in September, we found that universities were lagging far behind companies. 

We found that 68 per cent of company-sponsored trials due to report results had, but only 11 per cent of clinical trials from academic institutes across the EU had adhered to reporting requirements.

When we ask academic researchers why they have not reported their clinical trials they offer various excuses. Mostly, they talk about running out of time at the end of a research plan or running out of money at the end of a grant. 

Some just don’t seem to know that they are obliged, by law, to report them. It is true that companies are more used to operating in a regulated environment than academics – they generally want to sell a product at the end of a trial so have a strong incentive to obey all the rules. 

Large pharmaceutical companies, for example, often have more manpower than university research groups and will have dedicated legal teams focused on reporting. But there is no excuse for not reporting clinical trial results.

It may therefore be a surprise to learn that we have never seen enforcement action taken by regulatory bodies. This is despite the fact that, under EU and US law, clinical trial results must be reported within a year of the end of the trial, with the FDA even having the power to issue fines of $10 per day for unreported trials.

Simply put, universities have never been forced into action. Until now.

The Science and Technology Committee’s announcement that it will monitor clinical trial reporting by UK universities, and call to Parliament any bad performers, means that it has joined a growing movement of patient groups, students and researchers calling for all clinical trials to be reported. 

Over 90,000 people and 750 organisations worldwide have joined the AllTrials campaign alone.

The world’s largest research funders, including the Wellcome Trust, Gates Foundation and Médecins Sans Frontières, have agreed to review a researcher’s record of reporting results from past trials before issuing grants.

The Health Research Authority, meanwhile, is exploring how research ethics committees can monitor past compliance with reporting requirements before granting researchers permission to run a new trial.

This means that universities could risk their researchers being unable to get new funds or refused permission to run new research. Vice-chancellors could be called into Parliament if they fail to ensure that all clinical trials are reported. There are no longer any excuses.

If universities work on raising awareness of transparency requirements within academic departments, help their staff navigate the logistics, or even hire a dedicated member of staff focused on clinical trial reporting, they can begin to implement change. After all, many universities provide manpower to ensure that results are published in journals so why not have staff who can help ensure that reporting requirements are met?

The barriers to reporting results are now lower than ever before and we have seen some institutions – for example Kings College London – improve their trial reporting performance dramatically and rapidly. It may seem like a daunting process but groups, like AllTrials, are offering help and advice. 

AllTrials will also be monitoring the performance of UK universities over the coming months and will advise the Science and Technology Committee on universities that they may want to speak to. The time to act is now. Universities should consider themselves on notice. 

Síle Lane is head of international campaigns and policy at Sense About Science.