03 December 2018
The U.K. has been punching below its weight in attracting clinical research, and Brexit could provide an opportunity to remedy that, according to an industry body.
The Association of Clinical Research Organizations (ACRO) recently sent a series of recommendations to Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, with six policy recommendations that it thinks could elevate the country into the top tier of clinical research locations.
“Several specific regulatory, funding and business factors…put the U.K. at a disadvantage in relation to other countries,” says ACRO in a letter (PDF), adding that that the country’s withdrawal from the E.U. “has opened a ‘window’ for creative and innovative thinking about improving the attractiveness of the U.K. for clinical research."
First and foremost, ACRO wants to centralize the ethics review process, pointing out that there are currently more than 80 committees handling this across the U.K. and—as a result—reviews tend to be slow and variable and can delay the start of trials. It would like to see a fully-resourced national committee set up to make sure reviews take a set time, suggesting 15 days as an option, and are consistent.
Similar thinking is behind a call for centralized contracting, which ACRO says is also afflicted by “wildly varying” procedures and timelines. A single contract negotiation team would be able to cost trials against benchmarking data and speed up the process.
NHS England has suggested that 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, for example.
There are also difficulties in finding and recruiting patients into trials because under current National Health Service procedures doctors and clinical investigators cannot contact patients not under their direct care. This “right to write” approach should be allowed after ethics review of the contact plan, says ACRO, which suggests an independent organization such as the Wellcome Trust could help draw up a policy in this area that handles “concerns around privacy, data protection and engagement.”
Meanwhile, the U.K. has made much of the potential to use NHS patient data to drive clinical research, but ACRO maintains data access policies need to be reformed if it is to deliver on that promise.
Clinical researchers are currently finding it difficult to gain “appropriate and timely” access de-identified patient data in a timely fashion, and the gatekeepers of that data—such as NHS Digital and Health Data Research U.K.—should have specific guidance from government on how access should be enabled.
ACRO also calls for a greater emphasis on clinical research within healthcare trusts and supporting high-throughput clinical research facilities in NHS hospitals.
Earlier this year, NHS England said it was planning to implement new arrangements to “eliminate variation and delays in set up and reporting for commercial contract research.”
It has also published technical guidance on clinical trials during the Brexit transition period, which as it stands runs from March 30, 2019 to Dec. 31, 2020, indicating that E.U. rules and regulations including the new Clinical Trials Directive will remain in place.
Commenting on the proposals, ACRO's executive director Doug Peddicord said: "None of the policy proposals would be specifically blocked or facilitated by the EU. However, they were offered in the spirit of offering incentives for clinical research in the U.K., in part as a way of counterbalancing what are likely to be disincentives for clinical research in the U.K. post-Brexit."
He also told us that "movement of investigational and finished medical products in and out of England, movement of personnel across borders, tariffs, and more, all present challenges that impact the global competitiveness of the U.K. ACRO’s policy recommendations come as a way to rethink and optimize how clinical research is done in the U.K. and enable the success of work that impacts the lives of so many people in the U.K. and beyond."Print
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