UK should aim for 60-day trial approvals says review author

Government should develop metrics, establish a trial database and aim for 60-day approvals to encourage the growth of the clinical research sector according to the author of a review of UK drug study landscape.

The recommendations – some of the 27 issued by Lord James O’Shaughnessy and his team this month – is designed to make the UK a more attractive location in which to conduct clinical drug trials.

O’Shaughnessy - founder and senior partner at medical consulting group Newmarket Strategy – also concluded regulations covering drug trials need to be revised to accelerate start-up.

“The Medicines and Healthcare products Regulatory Agency, Health Research Authority and other system leaders should set up a rapid ‘task and finish’ group to produce a plan on reducing the regulatory burden of approving trials and removing delays in set-up, including with the goal of reaching a 60-day turnaround time for all approvals.”

He added that “additional funding should be provided by the UK government to the regulators, the MHRA and the HRA, to rebuild capacity and deliver reduced turnaround time for all approvals.”

O’Shaughnessy also highlighted clinical data transparency as a major stumbling block for the UK drug research sector.

To address this he suggested “The MHRA, the HRA, the NIHR and its equivalent organisations across the UK should collect, consolidate and publish national monthly returns on all the clinical trials activity that is happening in the NHS, and NHS bodies and commercial sponsors should publish numbers of patients in trials on a monthly basis.”

The creation of a trial directory – “clinicaltrials.gov.uk” is O’Shaughnessy’s suggestion – would establish a single source of activity for patients, clinicians, researchers and potential trial sponsors.

UK trial slump

O’Shaughnessy’s review was prompted in part by concerns that the UK clinical research activity is on a downward trajectory.

According to ABPI analysis published in October 2022 the number of industry-led trials initiated in the UK per year fell by 41% between 2017 and 2021.

As a destination for Phase III studies the UK dropped from being the fourth most active country globally in 2017 to 10th in 2021 with EU member states overtaking it.

In addition, there has been a 44% drop in the number of participants recruited for commercial clinical trials in the UK in last five years.

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