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NHS England pledges to streamline clinical trial setup

The process will also target the procedure for reimbursements in additional treatment costs

NHS

NHS England has said it plans to introduce new processes to tackle delays in setting up clinical trials before the end of the year.

While the UK as a whole is an established leader in early-stage clinical research, red tape can make it a lengthy process to arrange contracts to carry out trials across multiple NHS hospitals. There is no centralised contracting process and agreements have to be made with each site separately and - according to NHS England - it can take as much as nine months to get all contracts up and running.

To tackle the issue, NHS England has teamed up with the National Institute for Health Research (NIHR), Health Research Authority (HRA) and NHS Improvement to draw up “new arrangements to eliminate variation and delays in set up and reporting for commercial contract research”.

The move meets one of the recommendations in a public consultation on research in the NHS launched last November, which also found variations in the contract terms and prices for the same study. At the heart of the plans are standard arrangements for charging for commercial research for contracting and for performance reporting - via the NHS Standard Contract - that will apply right across the NHS in England.

The new processes will also try to simplify and speed up the process for reimbursements for excess treatment costs in non-commercial research, says NHS England. As a consequence, patients will benefit from quicker access to trials and the NHS will become “a more attractive place to undertake research”.

“Sponsors of commercial contact research currently face uncertainties and delays in site set up,” acknowledged Sam Roberts, director for innovation and life sciences at NHS England.

“The new arrangements will standardise the processes to introduce greater certainty and reduce administrative costs for both NHS providers and commercial sponsors for the first time in the NHS,” he added.

Standardised processes will help tackle part of the problems facing clinical research in the NHS, but others remain. Earlier this year, it was reported by Research Fortnight that the funding crisis in the health service mean that nursing staff were being diverted away from drug research to fill breaches in the provision of clinical care for patients.

Meanwhile, trial sponsors complain that the incentive to carry out trials in the UK is lessened by the fact that it is often slow to adopt new drugs when commercially available, and the Association of the British Pharmaceutical Industry (ABPI) has also warned of a possible impact on clinical research if the Brexit process is problematic.

Aisling Burnand, chief executive of the Association of Medical Research Charities (AMRC), welcomed the pledge to simplify processes and said it provides an opportunity for NHS England and the charity sector to come together to support high quality research that patients want and need.

“There is much to be resolved, including the Excess Treatment Cost (ETC) absorption thresholds and the rate at which [Clinical Commissioning Groups] pay into centralised funds,” she warned.

“This response outlines an initial ‘mark in the sand’ for these rates but the paucity of data to quantify ETCs requires these levels to be kept under review,” added Burnand, calling for NHS England and CCGs to “work together to commit to increased ETC funding” if they are found to be insufficient.

Article by
Phil Taylor

9th May 2018

From: Regulatory

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