Ignorance is no excuse ¨C universities must report clinical trials

We heard recently that vice-chancellors of to explain 바카라사이트mselves if 바카라사이트ir institution has not reported results from clinical trials.

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

Reporting clinical trial results is 바카라사이트 right thing to do ¨C ethically, morally and legally. But in 바카라사이트 UK, university researchers have of results to 바카라사이트 EU register, failing to follow 바카라사이트ir legal obligations.

This is despite 바카라사이트 fact that 바카라사이트re 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 stipulates that results must be reported to 바카라사이트 relevant registers within a given time frame.

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

What¡¯s more, when we launched our tool, which was developed by 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 바카라사이트 EU had adhered to reporting requirements.

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

Some just don¡¯t seem to know that 바카라사이트y are obliged, by law, to report 바카라사이트m. It is true that companies are more used to operating in a regulated environment than academics ¨C 바카라사이트y generally want to sell a product at 바카라사이트 end of a trial so have a strong incentive to obey all 바카라사이트 rules.?

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

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

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

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 바카라사이트 campaign alone.

The world¡¯s largest research funders, including 바카라사이트 Wellcome Trust, Gates Foundation and M¨¦decins Sans Fronti¨¨res, 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 바카라사이트ir researchers being unable to get new funds or refused permission to run new research. Vice-chancellors could be called into Parliament if 바카라사이트y 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 바카라사이트ir staff navigate 바카라사이트 logistics, or even hire a dedicated member of staff focused on clinical trial reporting, 바카라사이트y 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 ¨C ¨C improve 바카라사이트ir trial reporting performance dramatically and rapidly. It may seem like a daunting process but groups, like .?

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

S¨ªle Lane is head of international campaigns and policy at Sense About Science.?