A pioneering initiative led by UCLPartners has massively reduced the time taken to approve commercial clinical trials across the hospitals in the partnership.

The scheme, that has reduced average approval time by around 90%, is allowing more patients to access potentially life-saving and life-changing therapies, and has also led to praise from the pharmaceutical industry which will invest in more trials across the partnership as a result.

UCLPartners is an academic health science partnership made up of leading universities and hospital trusts across parts of London, Essex, Bedfordshire and Hertfordshire.

Previously, the cumbersome approvals process across these institutions (which still applies to hospitals elsewhere in the UK) meant that each individual hospital trust involved had to approve every part of any proposed commercial trial taking place on multiple sites.

This led to lengthy delays when, for example, a particular trust did not have a radiation expert available to approve a safety aspect of the trial, or a trust’s legal team was short staffed, or a whole catalogue of other reasons.

The delays were such that for many global commercial studies, sites in other cities around the world would have recruited all the patients they needed before the UCLPartners sites had finalised their approvals process and recruited their first patient.

Similar delays across the UK led the government to publicly declare its intention to cut the bureaucracy involved in medical research back in 2010 (NHS White Paper, Equity and Excellence: Liberating the NHS, July 2010).

In this ‘harmonisation’ project led by UCLPartners’ Professor Nick Lemoine (based at Barts Health NHS Trust, and Director for the new Comprehensive Clinical Research Network for central and east London), a collaborative approach with these institutions across north and central London* to approving new clinical trials has significantly reduced delays for approving new studies.

Through streamlining communications, reducing investigator administration workload, pooling resources and removing unnecessarily duplicated reviews, the project has reduced study-wide review time—the overall aspects of the trial covering things such as an assessment that the study is legally compliant, appropriately funded and safe, including risk assessments and consent—from an average of 104 days to 17 days.

The new procedures have also reduced the time needed for the local reviews (which need to be completed by each site involved, checking each has the appropriate staff, equipment and resources to run a study) from an average of 90 days to 10 days.

To put these figures into context, trusts within UCLPartners were previously low in national rankings for speed of approvals. However, current data shows that UCLPartners trusts now have the fastest turnaround time in the country for approving new trials.

Furthermore, having previously seen multiple occasions where UCLPartners trusts were the slowest to recruit patients in international studies, in two recent examples they were the first to do so. One of these trials is a European paediatric nephrology study (first in European Union to recruit) and the other is a gastroenterology study (first in the world to recruit).

These changes—implemented for 181 studies across the partnership—have immediately made UCLPartners (and by proxy, the UK) a much more attractive location to conduct commercial clinical trials, since 1 in 4 of all commercial studies in the UK has a lead-investigator based at UCLPartners. Now, permission is granted for a trial to take place in all UCLPartners sites involved from one of four ‘permission centres’, in which industry deals with one point-of-contact and has one contract for all sites.

These four hubs provide permission for new trials based on specialist areas: a hub for paediatrics, a hub for mental health and primary care, and two others provide permission for all other specialities including cancer and cardiovascular trials.

UCLPartners has also, as part of the project, assigned a single tariff to every process that the trusts could deliver as part of a clinical process, for example MRI scans and anaesthesia, with an outer or inner London weighting to the costs depending on the site where the trial is to be delivered, thus simplifying cost structures for potential commercial investors.  And instead of trusts having to wait for their next radiation expert or pharmacy expert to approve a part of the trial, the permission centres have access to all experts at all trusts, meaning the next available expert from any site steps in to deal with the necessary approval.

Chief executives of all trusts have also delegated their sign-off authority to the permission centres. “It’s almost like a taxi rank now,” says Professor Lemoine. “We have one co-ordinator based in the permission centre who organises the next available expert who is required to help sign off that particular part of the study. Experts are also pooled for essential parts of the process like the checking and calibrating of equipment. The many administrative hurdles that have frustrated the clinical trials process in the UK for so long will no longer hold up the progress of essential research.”

He adds: “Pharmaceutical companies that had originally only planned to open a study at one site can now open trials at multiple sites across UCLPartners without any extra administrative burden. The harmonisation project has massively improved our competitiveness and helped restore confidence in the NHS to deliver clinical research.”

As a result of the reduced approval times, the window in which studies can actually focus on recruiting patients has widened, since there will now be up to three months longer between the  approval date and the date any trial would close. “With more time available to recruit, more patients will be recruited,” says Professor Lemoine. “Thus these ‘extra’ patients will be able to access these therapies being tested in the trials, which are potentially life-saving or life-changing. The next stage of our project is to focus on improving the efficiency of our processes within the hospitals for recruiting patients onto trials.”

The faster approvals process has been hailed by major industry representatives. Lindy Jones, Global Head of Integrated Site Services at Quintiles, a major provider of biopharmaceutical development outsourcing services, says:  “There is significant pressure to speed the drug development process in order to develop treatments that enable people to live healthier lives.  We are proud to be working with the UCL Partners network to further enhance our ability to recruit patients and investigators who are critical to an efficient and effective drug development process. The streamlining of the approval process across multiple sites, in multiple hospitals is very impressive; the medical and scientific rigor required to safeguard patients remains while the administrative elements have been minimised.”

“This initiative presents UCLPartners with new opportunities to work more closely with industry to deliver cutting-edge medical research to patients across our population,” concludes Professor Lemoine.

Source: UCL