HealthWatch UK, Universities Allied for Essential Medicines UK, and TranspariMED today jointly called on the British government to set up a national audit system to monitor all clinical trials conducted in the country.
The audit system would monitor the registration, summary results posting and academic publication of every trial conducted in the UK.
A pilot has proven the feasibility of setting up a national system in the UK.
It would cost little to set up and run. It would not generate any red tape, costs, or time delays for institutions conducting clinical trials in the UK.
A national audit system would provide Britain with a competitive advantage as a location for cutting edge clinical research and drug development.
The failure of trial sponsors and principal investigators to prospectively register all trials, post the summary results of all trials, and publish the outcomes of all trials in academic journals is well documented.
As a consequence of incomplete and inaccurate reporting, patients are harmed, public health agencies cannot make informed decisions, public health funds are wasted, medical progress is slowed down, and shareholders are exposed to substantial risks.
Examples include Lorcainide, a drug that killed over 100,000 people over the course of a decade, Tamiflu, on which the NHS arguably misspent £424 million, and Vioxx, whose withdrawal led to shareholder losses of $37 billion.
The problem has been known for decades, but even today, many clinical trials are still not being pre-registered on trial registries (despite being required to do so by UK regulations), do not post summary results onto registries within 12 months (despite being required to do so for some trials by EU regulations), and/or are misreported in academic journals or not published at all.
Bringing UK practices into line with global best practices will require monitoring whether trials are pre-registered, post summary results within 12 months, and publish accurate results.
At present, the UK has no system for monitoring compliance with best practices and/or relevant regulations. The proposed national clinical trial audit system would fill this gap.
Every clinical trial conducted in the UK requires approval from one of Britain’s 68 regional Research Ethics Committees (RECs). A recent pilot project has demonstrated the feasibility of using documents already held by RECs to monitor retrospectively whether trials have been registered, posted summary results within 12 months, and published accurate results. Scaling up this pilot nationwide would create a comprehensive national clinical trial audit system capable of monitoring every trial conducted in the UK.
A national clinical trial audit system would cost little to set up and run. The pilot project covering all trials approved by an REC over two years was largely conducted by a single graduate student working part-time for one year. A national system would require far less input per REC due to economies of scale and the ability to adjust upstream processes to facilitate the audit function.
A national clinical trial audit system would not generate any red tape, costs, or time delays for companies, universities or individuals conducting clinical trials in the UK. It would also not create any additional work for RECs themselves, because the Health Research Authority (HRA) already holds the national archives of the required REC records.
Making the audit data publicly available would by itself substantially increase research integrity in the field. Trial sponsors’ and principal investigators’ track records would suddenly become visible and comparable, creating strong incentives to improve performance.
A national clinical trial audit system would provide Britain with a competitive advantage as a location for cutting edge clinical research and drug development.
The REC-based audit approach was piloted in the UK by Dr Simon Kolstoe, who has joined today's call for a national system to be established. In recent months, the AllTrials campaign and Dr Ben Goldacre have also called for a national audit system to be set up.
Today's call was made in the context of an ongoing enquiry into research integrity by the House of Commons' Science and Technology Committee. More details on the proposed audit system can be found here.