UK to set up new body to oversee clinical trials

The UK is to set up a new health research regulatory agency to streamline regulation and improve the cost effectiveness of clinical trials, with future funding by the National Institute for Health Research (NIHR) to healthcare providers being conditional on meeting benchmarks, including a 70 day benchmark to recruit the first patient into a trial.

This follows a report published in January this year calling for urgent changes in the regulation and governance of clinical trials in the UK to stop unnecessary delays, bureaucracy and complexity, stifling medical advances.

Commenting on the announcement of the new agency, Michael Rawlins, Chair of the Academy of Medical Sciences working group that wrote the report, ‘A new pathway for the regulation and governance of health research’ said he was delighted that the government has acted quickly saying, “The new Health Research Regulatory Agency must remove some of the current complexity and achieve greater efficiency by acting as a one-stop-shop for regulatory approvals.”

He added that streamlining how the providers of healthcare services approve research should be the highest priority. Plans to link future clinical trial research funding to a faster approval process, “Is a welcome step in improving performance.”

The government will said the new agency will combine and streamline the approval process for clinical trials, which at present involves many different national and local organisations. This will reduce the regulatory burden on companies and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK.

The first step will be the formation this year of a Special Health Authority to work with the UK regulator the Medicines and Healthcare products Regulatory Agency to create a unified approval process and develop standards for compliance and inspection within a consistent national system of clinical trials governance.