Meta researcher paradise: Complete data set of all clinical trials run in the UK
A data set released by the UK Health Research Authority provides a comprehensive overview of all 2,646 clinical trials that received ethics approval within the UK during the year 2019. The data offers meta researchers a unique opportunity to analyse an entire country’s clinical research activity.
In the UK, researchers must obtain ethics approval from one of the country’s regional Research Ethics Committees (RECs) before starting a clinical trial in the country. All approval records are subsequently centrally archived by the Health Research Authority. In contrast, REC records in most other countries remain locked away in the vaults of individual RECs.
The UK data set was released in response to a Freedom of Information request filed by TranspariMED and covers all approvals made in 2014 and 2019. The data set includes trials that were never registered on a trial registry, and that never published their results.
The data set distinguishes between four types of trials, and identifies the company, university or public body that sponsored each trial. Corresponding trial registry numbers are not included. While sponsor names are not normalised, data quality is very high overall. The data will open up new possibilities for meta researchers worldwide.
The Health Research Authority is expected to use a similar data set in future to annually audit the registration and reporting of all clinical trials conducted on UK soil.
A national transparency strategy outlining these plans was due to be released earlier this year, but its launch appears to have been delayed due to the COVID-19 pandemic.
Meta researchers have long struggled to get hold of comprehensive clinical trial cohorts:
Compiling cohorts from data on trial registries is difficult because trials may be dispersed across numerous registries, and some trials can be registered multiple times without obvious cross-linkage. In addition, registry-based approaches miss out the estimated 39,000 medical studies that, in violation of global ethics rules, are never registered in the first place.
Compiling cohorts from journal articles produces a skewed sample because the results of around half of all trials are never published.
Some researchers have reviewed the records of individual research ethics committees to create comprehensive cohorts that include unregistered and unreported trials. However, ethics committees are often reluctant to give researchers access to their files, and may place restrictions on what researchers can subsequently publish. In addition, cohorts based on individual ethics committee records tend to be small in size, and may not be representative of the broader research landscape.
Till Bruckner, founder of TranspariMED, said:
“The Health Research Authority’s release of this data set cements the UK’s position as a global pioneer in clinical trial regulation and research transparency. Meta researchers, patient groups and transparency activists elsewhere should examine closely whether and how the UK model of centrally archiving REC records and making REC data public can be adopted in their own national contexts.”
The full UK data set is available online and can be downloaded and used without restrictions.
Note to fellow meta researchers: Filing FOI requests in the UK is very easy, and the HRA usually responds within the 20 working days set out in UK law. Therefore, there are no barriers to obtaining comparative data for additional years. However, the HRA currently has to manage a surge in urgent COVID-19 related research activity. TranspariMED’s FOI request was filed prior to the current crisis. TranspariMED encourages fellow researchers to refrain from filing non-urgent FOI requests with the HRA until the worst of the crisis has passed. Thank you.