New research shows that most US academic institutions do not have policies to ensure clinical trials run by their researchers are registered and results reported. A survey of 366 universities in the US uncovered that less than half have a policy on registration of clinical trials (43%) and only around a third (35%) have a policy on results reporting.

91% of them have no policy to penalize researchers who breach their policy.

Three-quarters of the universities (74%) reported that they do not have an electronic system for monitoring and managing registration and reporting.

The median number of staff assigned to look after trial registration and reporting requirements in the organisations is 0.08% of a full time equivalent staff member. Those who have the most trials on the US register are more likely to have policies and staff assigned to manage those.

The researchers wanted to find out whether academic institutes were ready to respond to the FDAAA Final Rule, the law that mandates that many US clinical trials and all clinical trials funded by the US federal funder NIH must be registered on and report results there within a year of the end of the trial. The survey results meant the researchers had to conclude that the universities are not ready.

The researchers also found out that 14% of all the academic organisations with accounts on – that is 113 of them –  are responsible for 80% of all the applicable trials run by universities.

The authors of this research are from Johns Hopkins University Bloomberg School of Public Health and it is published in BMC Medicine

Dr Ben Goldacre, EBMDataLab, University of Oxford and co-founder of AllTrials: “This is hugely important work. Doctors and patients cannot make informed choices when the results of clinical trials are still being withheld from them. Pharma has begun to put its house in order, but academia is now falling behind. Some institutions are taking this seriously: some, clearly, are not, and this must change. Leaving results unreported is an insult to the patients who have participated in your trial.”


Síle Lane, Sense about Science, co-founder of AllTrials: “It is so disappointing that so many academic institutions seem to be doing nothing to ensure their researchers register and report trials. Without this, it’s a betrayal to the thousands of patients who will have volunteered for trials run by these organisations; it’s a waste of funders’ money and it means researchers are in breach of their obligations to report.