Health regulators risk ‘sleepwalking’ into a repeat of drug trial disaster

Health research regulators could be “sleepwalking” into an incident like the Northwick Park drug trial disaster that left a number of people in intensive care, according to a barrister and former ethics committee member.

An overhaul of the system designed to reduce red tape is in fact “cutting corners”, claims Christopher Roy-Toole in written evidence to a House of Commons committee.

But the Health Research Authority, set up by the government in 2011 to streamline the regulation of research in the health service, said the new approval process will “never compromise” patient safety.

In March this year the Department of Health awarded £4.5 million to the HRA to make the assessment and approval of research in the NHS more efficient. Changes to be brought in under the new scheme include taking legal decisions on clinical research at a central level, rather than by individual NHS Trusts, as is the case at the moment.

Earlier this year academics warned that the plan risked falling short of its goals of reducing bureaucracy and speeding up research approvals. Now Mr Roy-Toole, who is on a sabbatical after sitting on an NHS research ethics committee for six years, is raising concerns about the safety of the process.

“We are sleepwalking into something comparable to the Northwick Park disaster,” he told Times Higher Education, referring to a clinical trial at the north London hospital eight years ago that left six men in intensive care with organ failure. It was dubbed the “Elephant Man” trial because of the horrific side-effects experienced.

“Just because there hasn’t been a major safety accident reported in the UK since 2006 doesn’t mean there won’t be one in the future. What concerns me most is the unknown risk from clinical trials of licensed drugs in new dosages or new combinations…recent risk-adapted approaches to research regulation may under-estimate the possible harms from these,” he added.

In evidence to a legacy report on clinical trials being produced by the Commons Science and Technology Select Committee, Mr Roy-Toole said that the HRA’s assessment and approval scheme has a “critical safety weakness”, which could increase the risk of an accident. “[It] is not cutting ‘red tape’ in research governance, rather it is ‘cutting corners’,” he said.

The weakness is caused by the HRA failing to supply research ethics committees with adequate support to assess the science and safety issues of research, he said.

“Unless those failings are rectified…The HRA [assessment and] approval will not be worth the paper it is written on.”

The HRA said its role is to protect the interests of research participants. “HRA approval will never compromise patient safety. In fact it will strengthen the safety of research,” it said in a statement.

It added that it will be employing suitably trained and experienced staff to undertake the assessment of studies, based on standards that are being agreed with the NHS.

“These assessments will be undertaken alongside and integrated with the research ethics committee review that will continue to provide independent ethical scrutiny,” the HRA said.

“This new process will ensure that those legal and practical considerations that are outside the remit and capacity of research ethics committees inform the committees’ deliberations,” it added.

holly.else@tesglobal.com