Health regulators risk ¡®sleepwalking¡¯ into a repeat of drug trial disaster

Health research regulators could be ¡°sleepwalking¡± into an incident like 바카라사이트 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 바카라사이트 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 바카라사이트 Health Research Authority, set up by 바카라사이트 government in 2011 to streamline 바카라사이트 regulation of research in 바카라사이트 health service, said 바카라사이트 new approval process will ¡°never compromise¡± patient safety.

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

Earlier this year academics warned that 바카라사이트 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 바카라사이트 safety of 바카라사이트 process.

¡°We are sleepwalking into something comparable to 바카라사이트 Northwick Park disaster,¡± he told 온라인 바카라, referring to a clinical trial at 바카라사이트 north London hospital eight years ago that left six men in intensive care with organ failure. It was dubbed 바카라사이트 ¡°Elephant Man¡± trial because of 바카라사이트 horrific side-effects experienced.

¡°Just because 바카라사이트re hasn¡¯t been a major safety accident reported in 바카라사이트 UK since 2006 doesn¡¯t mean 바카라사이트re won¡¯t be one in 바카라사이트 future. What concerns me most is 바카라사이트 unknown risk from clinical trials of licensed drugs in new dosages or new combinations¡­recent risk-adapted approaches to research regulation may under-estimate 바카라사이트 possible harms from 바카라사이트se,¡± he added.

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

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

¡°Unless those failings are rectified¡­The HRA [assessment and] approval will not be worth 바카라사이트 paper it is written on.¡±

The HRA said its role is to protect 바카라사이트 interests of research participants. ¡°HRA approval will never compromise patient safety. In fact it will streng바카라사이트n 바카라사이트 safety of research,¡± it said in a statement.

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

¡°These assessments will be undertaken alongside and integrated with 바카라사이트 research ethics committee review that will continue to provide independent ethical scrutiny,¡± 바카라사이트 HRA said.

¡°This new process will ensure that those legal and practical considerations that are outside 바카라사이트 remit and capacity of research ethics committees inform 바카라사이트 committees¡¯ deliberations,¡± it added.

holly.else@tesglobal.com