Early approaches to CRN Coordinating Centres, achievable yet “challenging” site recruitment targets, prompt contract discussions with sites, clear and open lines of communication, and involvement of senior stakeholders in escalating extraordinary issues – these were among the leanings for industry from Phase II of the multi-stakeholder North West Exemplar Programme (NWEP).
“Stakeholders had a range of experiences during the Exemplar Programme, but those who were proactive and set up clear communication channels at the onset found a collaborative ‘Exemplar culture’, which facilitated shared learning, led to improved working methods and delivered better outcomes,” said the Phase II report from the National Institute for Health Research Clinical Research Network (NIHR CRN).
The NWEP was launched by the NIHR NHS /Biopharmaceutical Industry R&D Leadership Forum, which includes senior representatives from the NHS, the biopharmaceutical industry, the Department of Health and the NIHR CRN Coordinating Centre, in the summer of 2009.
It was set up to provide evidence that the National Health Service in England is a viable environment for commercially sponsored clinical trials, one that can match the best in Europe on quality, speed, efficiency and hitting recruitment targets.
Phase I of the project was about mobilising effective study set-up through the NIHR Clinical Research Networks. A progress report on this element of the scheme was published in July 2010. Phase II, the subject of the latest report, was concerned with effective study delivery.
In fact, the metrics on study delivery are still relatively thin on the ground. Of the 20 participating studies in the NWEP, so far six have completed recruitment and two of these exceeded their recruitment target, while two other met their recruitment target and two did not reach their target, the Phase II report noted.
As for the remaining 14 studies, recruitment is “either on or ahead of target, according to recruitment plans and milestone schedules”, it added.
Otherwise, the Phase II report confirmed, with some adjustments and more comprehensive analyses, the progress seen last July in set-up times and first patient enrolments through the NIHR CRN networks in the North West.
These metrics are summarised below. The figures refer specifically to sites in the North West area that came under the scheme. None of the 20 Exemplar Programme studies have been conducted exclusively in the North West of England, and for some the region constituted only a very small proportion of the overall trial activity.
Metric Calendar Days
R&D Form validation to NHS
Permission at first site 54.5
SSI Form Validation to NHS
Permission (all sites) 26
R&D Form to first patient – first
visit (first site) 72
NHS Permission to first patient –
first visit (all sites) 17
Valid costing template received
to agreement of costings 5
Final contract received to signature 2
CSP governance checks completed to
Issue of NHS Permission letter 1
SSI = Site Specific Information; CSP = NIHR Coordinated System for Gaining NHS Permission
Good recruitment practice
As the Phase II report points out, recruitment to time and target “is the metric that Industry is most interested in”. A final report on the NWEP will be published in 2012, when the majority of the Exemplar studies will have closed to recruitment.
The latest report gives examples of good practice that have facilitated recruitment, such as:
• pre-screening large numbers of patients where possible;
• research nurses operating as an integral part of the clinical team and attending outpatient clinics;
• accessing the full patient population by building on the investigator’s links with other clinicians, educating clinical staff about research in general and individual studies, and having research open days;
• using specific routes such as community services to refer patients;
• resource planning both by sites and industry;
• clarity about study-specific processes needed during the recruitment phase.
Phase II of the Exemplar Programme incorporated an independent project analysis called ‘Capturing the Learning’. Led by Manchester Business School, it used interviews with key participants in the NWEP to identify good practice and provide examples of how challenges during study set-up were identified and overcome.
The report includes a summary of the recommendations arising from this analysis (see industry learnings above), grouped around the themes of Process, People and Communication, and tailored to the three stakeholder groups: Life Science Industries, NHS Chief Executives, and NIHR Clinical Research Network and site staff.
The next phase of the NWEP will be roll-out and adoption of these recommendations across England. Key stakeholders from the life sciences industry, the NHS and the Clinical Research Network are now forming guidance groups to determine how these goals can be achieved most effectively, the NIHR CRN noted.
CRN chief executive Dr Jonathan Sheffield said it was vital that key stakeholders continued working together to build on the success of NWEP.
“Collaboration has proved crucial to Exemplar study successes and will remain so during the roll-out phase of the programme in 2011,” he commented.
“We can only replicate the Exemplar culture in the rest of England if we retain the support and commitment of the clinical research community, and we are currently working with project partners to ensure Exemplar recommendations become an everyday aspect of the clinical research landscape.”
The Association of the British Pharmaceutical Industry, “recognises the importance of the Exemplar Programme as a showcase for clinical research in the UK”, pointed out medical and innovation director Dr Allison Jeynes Ellis.
“We are on a journey in terms of improving our competitiveness in clinical research and the continued collaboration between the pharmaceutical industry and NHS is vital to nurture the health and wealth of the nation”.
One positive industry experience in the report also highlighted the challenging global environment in which UK clinical research competes.
Tim Cave, medical director at Novartis Pharmaceuticals UK, said the company “embraced the North West Exemplar project and as a result of excellent team work between NHS, NIHR and industry, achieved rapid set-up and global first patient first visit (FPFV) on a key heart failure trial”.
Fast start-up times “not only maximise patient recruitment and give the UK the best chance to deliver the target number of patients; they also differentiate the UK from other countries such as China,” Cave added.
“Although China recruits patients for trials quickly, that recruitment is preceded by long lead times. As a result of the fast set-up and global FPFV seen on the North West Exemplar project, Novartis has attracted more studies into the UK, and we continue to see the UK as an important site for research.”