World first: UK starts monitoring all clinical trials to check if they report results

The UK this week began monitoring whether clinical trials make their results public as part of a national strategy for ensuring that all clinical trials are registered and report their results.

The monitoring system covers every interventional clinical trial involving UK patients, including trials of drugs, medical devices and non-drug interventions, and international trials with study arms in the UK.

The system is run by the Health Research Authority, which occupies a unique gatekeeper position because it oversees all ethics committees in the country. The HRA centrally archives documentation from all ethics approvals, including trial protocols. This gives the HRA an overview of all trials run in the UK.

Announcing the launch, Juliet Tizzard, Director of Policy and Partnerships at the HRA, said:

“We know that most researchers want to be transparent and just need help to do that.”

HOW DOES THE NEW MONITORING SYSTEM WORK?

The monitoring system was developed as part of the wider #MakeItPublic strategy, which was adopted in the wake of a 2018 parliamentary enquiry into missing trial results.

The monitoring system is based on an end-of-study checklist. One year after completing a trial, researchers must fill out an online form stating where the trial was registered, and confirm that they uploaded the trial’s results onto that registry.

The HRA does not mandate the use of a specific registry. The system does not create any additional bureaucracy on researchers.

The Health Research Authority already monitors whether trials are prospectively registered, chases up researchers who forget to register their trials, and makes that monitoring data public. The latest monitoring report explains in detail how the system works. It found an 84% compliance rate.

(According to the #MakeItPublic implementation plan, the HRA itself will from January 2022 onward directly register clinical trials after ethics approval has been granted, ensuring a 100% registration rate and thus eliminating the problem of unregistered trials once and for all.)

This week’s move extends the same approach to results reporting. The HRA can easily verify whether a trial has made its results public by checking its trial registry entry. That data will be included in future monitoring reports.

Till Bruckner, founder of TranspariMED, said:

“The Health Research Authority’s new monitoring system is a huge step forward, and cements the UK’s position as the global leader in clinical trial transparency. Hopefully, patients in other countries will soon demand that their governments put similar systems in place."

"Meanwhile, TranspariMED will continue to urge UK policy makers to back up this excellent system with effective sanctions to ensure that not a single trial result slips through the net. Unreported clinical trials leave large gaps in the medical evidence base, which harms patients and undermines public health.”

CALL FOR EU COUNTRIES TO ADOPT SAME SYSTEM

A member of the European Parliament called for other European countries to follow the UK's lead. In a Tweet, MEP Tilly Metz commented that:

"That’s the way forward - all European Union countries should do the same!"

"Unreported Clinical Trials leave huge unnecessary gaps in the medical evidence, which harms patients and undermines public health."

No European body has oversight over all clinical trials conducted within Europe, so comparable systems would have to be set up at the national level, by national governments.

UK PARLIAMENT TO DEBATE SANCTIONS

UK researchers who fail to make trial results public within the one-year deadline may be refused future ethics approvals, effectively barring them from starting up new trials in the UK. However, the HRA has not set a date for introducing this sanction yet.

In August 2019, twelve health and integrity groups including Transparency International, Cochrane, the International Alliance of Patients’ Organizations and TranspariMED in an open letter called for a “clear timetable for the phasing in of sanctions.”

UK parliament, which itself has repeatedly called for sanctions, is likely to revisit the issue during a forthcoming enquiry into the reproducibility and integrity of research.

TranspariMED encourages individuals and organisations passionate about patient safety and public health to share their perspectives with parliament. Submissions to the enquiry can be made until 30 September using this link.