Call for urgent reform of clinical research rules in the UK

Urgent changes are needed in the regulation and governance of clinical trials in the UK to stop unnecessary delays, bureaucracy and complexity, stifling medical advances. A single Health Research Agency should be set up to replace the proliferation of regulatory bodies currently involved in approving and overseeing clinical research, according to a report by the Academy of Medical Sciences.

Michael Rawlins, Chair of the group that wrote the report, said the current system of regulation is making it increasingly difficult to set up clinical trials, and is preventing patients from participating in studies. “This is ultimately denying patients early access to new drugs and hindering improvements to public health,” Rawlins said.

The group, appointed in March 2010 by the then government to carry out the investigation, found unequivocal evidence that health research, “is being jeopardised by a regulatory and governance framework that has become unnecessarily complex and burdensome,” according to Rawlins. There is no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in research. “The changes we propose will streamline and improve the process to create a better environment for research,” Rawlins said

As a specific example of the kind of delay researchers experience, a recent analysis by the charity Cancer Research UK showed that after it has agreed to fund a study, it takes an average of 621 days to recruit the first patient. Harpal Kumar, chief executive of Cancer Research UK, says the process for getting clinical and health research up and running in the UK is “unacceptably slow.”

“We strongly welcome the report and support its recommendations,” Kumar said. We believe that a single health research agency could reduce the time it takes our researchers to get approval for their studies to 60 days [and] urge the government to take forward these recommendations without delay.”

An increase the complexity and cost of carrying out trials is happening across western Europe. Most of those involved point a finger of blame at the European Union’s Clinical Trials Directive of April 2001, introduced to harmonise the rules for clinical studies across the EU, for generating the bureaucratic burden.

First, the directive is not applied in a manner that is proportionate to the risk. This mean trials of existing marketed drugs in new indications are subject to the same level of oversight as trials involving novel therapies in first-in-human studies. Similarly, small-scale academic trials are expected to match all the reporting and information standards demanded of large-scale industry sponsored trials.

Second, although the EU Clinical Trials Directive sets out what is required, each member state takes the list of requirements and translates them into national laws. While Luxembourg decided no new rules were necessary to comply with the directive, in the UK it is embodied in a 129-page statutory instrument, plus an amendment that is another 130 pages long.

Third, academic researchers complain that the directorate was agreed between the European Commission and the pharmaceutical industry, and does not take account of the differing requirements of academic clinical trials. The commission has acknowledged there is a problem and the directive is being reviewed.

A genuine, single regulator

According to the Academy of Medical Sciences’ report, the answer in the UK is to set up a new independent Health Research Agency (HRA) to bring together existing approval processes and develop an integrated approvals system. National Research Governance Service housed within the HRA, will facilitate rapid approval of research studies conducted in single or multiple sites by assuming responsibility for all the checks that are currently duplicated by each participating site.

Rawlins said it is “vital” that the HRA is established as soon as possible. “To achieve its goals it will have to be a genuine single regulator and not a mere façade hiding the continuation of many separate existing bodies,” he concluded.