The UK is on track to become the first country to finally fix the problem of unreported clinical trials. Here’s how the UK system works, in 153 words and 1 chart.
Fixing clinical trial registration
Ethics committees (about 60 countrywide) send the protocols of all studies that they approve to the Health Research Authority in London. Staff at the Health Research Authority (HRA) then directly register every clinical trial on the ISRCTN registry. After the trial has been registered, the principal investigator of the trial takes over registry management, and is responsible for keeping the registry entry updated and uploading the results.
Fixing clinical trial reporting
Because it directly registers all trials run in the country, the HRA has a comprehensive overview of all clinical research. One year after a trial has been completed, the HRA checks on the registry to see whether the results have been uploaded there. If not, it sends a reminder to the principal investigator. The HRA also publishes annual trial audits that in future will show who has made their trial results public on time, and who has not.
All interventional trials involving UK patients covered
100% of trials registered
100% of trial results made public
Faster sharing of results
Less bureaucracy for researchers and trial sponsors
Cost and value for money
The exact cost of developing and implementing the strategy is unclear because it involves work by multiple players. However, the total cost to all players combined is certainly less than one million Euros, a marginal amount compared to the large direct costs (waste of research funding) and indirect costs (suboptimal HTA, procurement and treatment decisions) associated with letting clinical trials go unreported.
Modern governments routinely track millions of driving licenses and tax returns.
It’s clearly possible for modern governments to track a few thousand clinical trials.
It’s clearly possible for modern governments to fix this problem, once and for all.
New policy brief
TranspariMED has produced a two page policy brief that explains how the UK approach works.
Please share the policy brief below with decision makers in your own country.
To learn more about how student activists, campaign groups and political leaders worked together to make the UK's reforms a success, read this paper.