Press Release

IQVIA, the global leader in clinical trials and real world evidence research, has set out a twelve-point plan to restore the world-leading credentials of the UK’s clinical research environment, after welcoming confirmation of increased resources for clinical research announced as part of this Wednesday’s 2020 Spending Review. The plan was part of IQVIA’s submission to the UK Clinical Research Coalition, co-chaired by Baroness Blackwood of North Oxford and Dr Jonathan Sheffield, who led the National Institute for Healthcare Research Urgent Public Health programme during the height of the first wave of the pandemic.

In its submission, IQVIA notes that the UK currently attracts less than 4% of global commercial clinical trials activity, and that clinical trials can be launched five times faster in the USA, and twice as fast in Poland. OECD (2017), ‘Research and Development Statistics (RDS)’

IQVIA currently undertakes over 20% of UK clinical trials-and has taken a leading role in developing COVID-19 treatments through a hyper-accelerated clinical trial platform in the ACCORD study involving UK Research and Innovation (UKRI), the National Institute for Health Research and partners in the pharma, biotech sector and the UK government. IQVIA is currently leading clinical research on a number of COVID-19 vaccines.

In the Spending Review released by the Treasury to accompany the Chancellor’s statement to Parliament on Wednesday (25th November), Chancellor Rishi Sunak MP confirmed the provision of a research and development (R&D) budget of £1.3 billion to continue research into better patient outcomes, as well as supporting the wider UK life sciences sector.

Responding to the Treasury CSR statement, IQVIA Senior Vice-President, Tim Sheppard said:

“This week’s announcement of additional sectoral funding is hugely welcome and indicates that the Government absolutely understands and values the critical role that the UK’s clinical research environment has played in developing life-saving medicines and vaccines for COVID-19-and also the massive opportunity that is open to us as part of developing the Global Britain initiative.

“It is no understatement to say that if we can turbocharge the UK research environment, we can unlock transformative health, economic, and social benefits for the country. This will further enable the UK healthcare ecosystem to deliver transformative benefits for the patients of today and tomorrow – and as the UK’s most productive sector support economic recovery by attracting new global investment from international pharmaceutical and biotech companies.”

The full 12-point plan recommended by IQVIA is:

1. Establish a single National Ethics Committee to accelerate commercial clinical trial start-up. Currently every NHS Trust must provide local approval (through 87 local ethics committees) for commercial studies that already have the required national and ethical approval. This fragmented ethics system does not have the review capacity, nor sometimes the expertise for efficient review, making starting multi-centre commercial clinical trials in the NHS a process that can take up to 18 months-putting the UK at a competitive disadvantage. A funded single National Ethics Committee with full time experts specifically set-up to review commercial research would be able to deliver rapid and quality ethics approval - and crucially have the appropriate expertise in next generation research – for example Genomics, virtual trials, synthetic studies, adaptive design.
2. Centralise contracting and set a single research tariff to make UK price competitive. In the global clinical trial environment, the UK has a reputation for being an expensive research destination. This is due to significant variation across NHS Trusts in research pricing schedules, this creates further delays for starting multicentre studies, as prices must be negotiated at each Trust. Centralised contracting supported by a single national research tariff would not only negate such delays but ensure NHS patients get equitable access to study sites based on expertise not price.
3. Introduce the ‘Right to Write’ to empower Doctors to be able to digitally search Electronic Medical Records and directly contact patients not in their immediate direct care, but who would be suitable and potentially benefit from being recruited to a study relevant to their health condition and be invited to participate in the study.
4. Introduce a research opt-out standard and national policy for the use of non-identified patient data for research. Adopting an opt-out approach, underpinned by a public education programme on the benefits of clinical research would rapidly increase the cohort of patients available for both academic and commercial clinical studies.
5. Systemise the UK’s rich health data ecosystem to improve site identification and accelerate patient recruitment, model research sites capabilities through data to match to study requirements, develop a tiered approach with 1st and 2nd wave sites, based on their approach to drive research technology adoption and enable faster data sets to be built through a standardised approach. In 200 IQVIA US studies the application of AIML demonstrated a 40% acceleration of identifying suitable research sites and found that sites prioritised by an AIML approach have nearly 60% fewer non-enrollers in studies that have completed recruitment. Data and AIML-enabled research should be embedded in the NHS digital policy going forward.
6. Incentivise GPs (potentially through the GP contract) and consultants to ensure that clinical trials become mainstreamed as a routine option for NHS patients It is vital that patients, irrespective of their location and medical history, know that clinical trials are a possible care option. Steps have been taken by the NHS and by independent organisations such as PatientsLikeMe and useMydata to encourage patients to ask about trials and have their de-identified data used for research - all clinicians should be encouraged to talk to their patients about trial options. This is particularly true for primary care, where less than one percent of practices are active in commercial research compared to 99 per cent of Hospital Trusts
7. Digitise GP recruitment of patients in studies to address the limited consultation time with each patient by accelerating the adopting of digital innovations such as IQVIA ‘One Click’ studies and introduce electronic pre-screening to improve the ‘pick-up’ rate. Educate the general public about the benefits of clinical trial participation through a public engagement programme and make a new addition to The NHS Constitution-having a right to be offered access to a clinical trial if there is a suitable study available – and GPs having a duty of care to provide this choice. Introduce electronic pre-screening to replace manual screening to improve the ‘pick-up’ rate.
8. Establish a Nationally Funded Molecular Pathology (NMP) Testing Approach that links Genomics England and NMP programmes for on-site digital access to whole genome sequencing for patients in parallel to the clinical trial. Finding eligible patients for research in the UK remains a highly manual process, an NMP would transform the application of the unique research offering in the UK- NHS Data, integrated health system, Genomics England, the UK Biobank. A national molecular pathology body would also be able to address the challenges faced by some Genomic Laboratory Hubs where there may not be adequate expertise and resourcing in cancer genomics and bioinformatics. This would enable routine national patient equity in access to innovation.
9. Expand NHS Digital (in partnership with HDR UK) Trusted Research COVID-19 Environment Service to Long Term Plan therapeutic priority areas -prioritise the TRE service for cancer research in the first instance to urgently address the impact COVID-19 has had on cancer research and patient outcomes.
10. Link oncology clinical trial-data with PHE’s National Cancer Registration and Analysis Service (NCRAS), optimising existing datasets to flow between clinical trial and routine care settings.
11. Ensure that the UK becomes the regulatory and licensing ‘kitemark’ country in the world, via the MHRA being the go-to first choice regulatory authority for global pharma, biotech and medtech. This would move the UK from being a ‘participatory’ country to be a landmark registration country, running full studies not a small element of them as is the case today. The ambitious plans of the MHRA to accelerate licensing and start-up post-transition and their exemplary response to COVID-19 study approvals must be supported by collaboration between commercial research organisations, industry and Government. The MHRA should take mainstream RWE in its approvals and take advantage of the EMA’s slow progress in the application of RWE/RWD. The MHRA should also ensure health economic and societal values become routine parameters in clinical research protocols - the MHRA should be to be the conduit between clinical trial and NICE/SMC HTA approval by an MHRA programme that positively discriminates research protocols that include health economic parameters.
12. Align to EU Clinical Trial Regulation (CTR) and Clinical Trial Portal in event of a no-trade deal exit from the EU.

IQVIA Senior Vice-President, Tim Sheppard said:

“This agenda has to be one of the great opportunities for UK plc - to seize the potential for the country if we get the research environment right. This twelve-point plan has the potential to turbocharge UK research and transform health outcomes, if the spending review places appropriate urgency on implementing the urgent recommendations of the Clinical Research Coalition forthwith.

“The COVID-19 pandemic has clearly demonstrated to the public the overwhelming national benefit that can be derived from world-leading research-with the UK spearheading treatments and vaccines for the virus. We need the Government to take the steps necessary to restore our world-leading research credentials and make the UK the global number one destination for regulatory approval.”

To learn more:

• The Clinical Research Coalition is an independent community of thought leaders from the clinical research, industry, regulatory and governmental sectors.
• The 2020 Treasury Spending Review document at paragraph 6.13 confirms:
  “The government is providing a DHSC research and development (R&D) budget of £1.3 billion to continue the world-leading work of the National Institute for Health Research (NIHR) and Genomics England (GEL) and their research into better patient outcomes, including on Covid-19, as well as supporting the wider UK life sciences sector. SR20 also provides £559 million to support the modernisation of technology across the health and care system, including the NHS’s Artificial Intelligence Lab.”