UK national audit finds 130 clinical trials that violated ethics rules

A national audit of clinical trials receiving ethics approval in the UK found that 130 trials had remained unregistered, in violation of national and global ethics rules.

On the positive side, more than four out of five trials covered by the audit had been registered.

Preregistration of clinical trials is a cornerstone of transparency and integrity in medical research. Trial registry data provides a global overview of who is currently researching which treatments, helping to avoid needless and costly duplications of research efforts. In addition, defining the success criteria of a trial in advance limits the scope for shifting the goalposts after a trial’s results are in.

For this reason, since 2013, UK ethics committees have required researchers to promise to register their trials following ethics approval. In the same year, the Declaration of Helsinki made trial registration a global ethics requirement for all trials. However, researchers do not have to register trials before applying for ethics approval, and post-approval registration is rarely monitored in practice.

The UK is still the only country worldwide to systematically monitor compliance with trial registration requirements on the national level.

The UK Health Research Authority routinely archives approval documents from the dozens of Research Ethics Committees across the country. For its latest audit, it created a list of all 512 non-drug trials approved during the first half of 2018 and searched trial registries for corresponding entries. (Drug trials had been automatically registered by the national regulator, and so were excluded from the audit.)

The audit found an overall compliance rate of 84%. Medical device studies had a compliance rate of 82%. These figures are similar to the findings of a previous audit conducted last year. The audit did not distinguish between trials that were registered prospectively and retrospectively.

Where no registration was found, the Health Research Authority followed up with investigators and/or sponsors via email. These emails prompted at least 30 investigators to retrospectively register their trials, or pledge to do so.

The Health Research Authority only released aggregate data, making it impossible for trial participants and patients to identify which companies and institutions had failed to ensure that ethics rules were adhered to. TranspariMED will file a Freedom of Information request to obtain the full data set, and will make it publicly available on this blog.

In future, the Health Research Authority itself will centrally register all clinical trials following ethics approval.

Once the new system is in place, the UK will become the first country worldwide to ensure a 100% clinical trial registration rate. The planned system forms part of the UK’s #MakeItPublic national strategy for clinical trial transparency. A detailed implementation timeline has not yet been announced.

Till Bruckner, founder of TranspariMED, said:

“The Health Research Authority’s latest audit, conducted against a backdrop of tight budgets and the pandemic, underlines that the UK is already miles ahead of other European countries in terms of clinical trial transparency, and that it is determined to progress even further.”

“It is no coincidence that the country running some of the world’s best Covid trials is also a global leader in transparency – research transparency and overall research excellence go hand in hand. In future, the Health Research Authority should proactively release line-by-line data for all trials covered by its audits.”

The full audit report and aggregate data can be found on the Health Research Authority website.