NHS England to fast track clinical trials and improve access for patients

New processes to simplify the NHS research set up process and cut delays will be implemented this year.

In some cases there can be a difference of up to nine months between each hospital taking part in a multi-site trial being confirmed, which delays the start of that trial which could be for cancer or dementia research.

NHS England, working with the National Institute for Health Research, Health Research Authority and NHS Improvement, will introduce new arrangements to eliminate variation and delays in set up and reporting for commercial contract research and ensure the process for reimbursements for excess treatment costs in non commercial research are simplified and streamlined.

As a result patients will benefit from quicker access to trials and the NHS will become a more attractive place to undertake research.

Dr Sam Roberts, director for innovation and life sciences at NHS England, said: “The NHS has a long history of scientific breakthroughs and, in the NHS’s 70th year, we are committed to breaking down the barriers clinicians face when trying to set up new research projects.

“In implementing these new arrangements NHS England are fulfilling the first of our commitments to improve how the NHS supports and applies research. Cutting the current bureaucracy, variation and eliminating delays will increase patient’s access to research and the latest treatments, and support the life sciences industry.”

Sponsors of commercial contact research currently face uncertainties and delays in site set up. 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. Patients will benefit from quicker access to trials and the NHS will become a more attractive place to undertake research.

For excess treatment costs associated with non commercial research we are streamlining processes for their reimbursement moving to a consistent process across England with a single point of access and utilising the existing expertise in the system. The new model will address the frustrations currently experienced by researchers, commissioners and providers due to the complexity and variation of current processes.

The proposals were subject to a public consultation earlier this year which indicated strong support for the changes that were outlined. We have listened to our stakeholders and their feedback has shaped the original proposals into the plans for delivery we have outlined today.

The new arrangements are the first part of a wider set of commitments, ‘Twelve actions to support and apply research in the NHS‘ that NHS England and NIHR made in November.

Professor Chris Whitty, Government chief scientific officer, said: “These proposals are a great example of how NHS England is working with the wider health and care system to tackle some of the ingrained challenges facing research today. The Department of Health and Social Care is fully supportive of these proposals and will continue to work with NHS England and other partners to make them a reality.”

Peter Ellingworth, chief executive of The Association of British Healthcare Industries (ABHI), said: “We must find better ways of adopting innovation, and research is a critical part of this process. By simplifying the landscape, and crucially, speeding up the process in which research is set up, everyone benefits.

“I commend the changes outlined in the consultation response and look forward to working with the NHS to support its implementation.”

Nick Kirby, managing director of the Shelford Group, said: “Across the Shelford Group our research and clinical teams have been successful in accelerating the growth in clinical trials over recent years. This helps provide patients with access to the latest treatments and makes an important contribution to the evidence base for future healthcare innovations.

“Having a national leadership committed to the long term growth in research for patient benefit is welcome. We will continue to work with national leads to support the success of the UK as an international exemplar for research and innovation.”

Aisling Burnand MBE, chief executive of the Association of Medical Research Charities (AMRC), said: “We welcome NHS England’s response to this consultation to simplify arrangements for research in the NHS. This represents an opportunity for NHS England and the charity sector to come together to support high quality research that patients want and need.

“AMRC members invest significant amounts of funding on research in the NHS and it’s important that the voice of the charity sector is heard in these discussions.

“There is much to be resolved, including the Excess Treatment Cost (ETC) absorption thresholds and the rate at which CCGs pay into centralised funds. 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.

“Should they be insufficient, NHS England and CCGs must work together to commit to increasing ETC funding. We must not lose sight of the important benefits research brings to patients and the NHS itself. This requires all of us to be suited towards the detailed cooperation needed to ensure high quality research is both encouraged and supported.”

The full consultation response has been published on the NHS England website here.