Costing and contracting has caused headaches and delays for life science companies since the inception of the multi-site study. Matt Cooper, Director of Business Development and Marketing of the NIHR Clinical Research Network Coordinating Centre, explains how the UK is tackling this universal issue head-on by introducing a new standardized national approach to costing and contracting for all National Health Service (NHS) sites in England conducting commercial clinical research.
In the UK huge efforts have been made to improve the clinical research landscape over the last decade, and with justifiable success. Last year the National Institute for Health Research (NIHR) Clinical Research Network (CRN), which supports and monitors 70 percent of the clinical research that takes place in England,1 published record levels of research participation. Over 870,000 people took part in clinical research (including both commercial and non-commercial) during 2018/19, a 54 percent increase from 2010/11. Drilling down to commercial contract research alone reveals an impressive 229 percent increase in recruitment to 46,064 participants in 2018/19 from 13,987 over the same period.
Growth in the volume of commercial contract research studies has also been strong over the last few years. In 2018/19 fiscal year the NIHR Clinical Research Network (CRN) supported 1,523 commercial studies in the NHS, compared to just 415 in 2010/11 - a 266 percent increase.
It is well known that when it comes to clinical research the UK’s most valuable asset is our world class National Health Service (NHS) – the largest single-payer healthcare system on the planet. But perhaps less well-known is the role of the NIHR - often described as the clinical research arm of the NHS, and widely recognized as the most integrated clinical research system in the world.
The NIHR was created in 2006 and is funded by government to improve the health and the wealth of the nation through research, receiving £1 billion per year, half to fund health and care research grants, and half to provide the research infrastructure (people, facilities and technology) that enables research to thrive. Around £500 million is spent on clinical research infrastructure to support research in the NHS and the results (described above) are a testament to the NIHR’s success. The NHS offers a vibrant research environment, and an excellent test bed for the life sciences industry. Yet on an increasingly competitive global playing field, more needs to be done to ensure the UK maintains its position as a global leader in clinical research delivery.
Having demonstrated that the UK can deliver large numbers of participants into clinical trials, attention has now turned to where we can make improvements to achieve more rapid and streamlined set up and delivery of clinical research. Work is now underway to standardize the costing and contracting processes for all NHS sites delivering commercial contract research.
Work began back in December 2017 when NHS England published a 12 point action plan to simplify and strengthen arrangements for clinical research in the NHS. Immediately after publication, NHS England launched a consultation on two of the actions in the plan, one of which was to “further improve and eliminate delays in commercial contract research set-up”.
The consultation proposed options to streamline and improve the process for commercial contract research, including eliminating uncertainties and delays in site set up for commercial contract research, making the NHS in England a more attractive destination for commercial research.
170 individuals and organizations responded to some or all of the commercial contract research section of the consultation and 54 individuals attended face to face listening events. Respondents included a strong industry presence: 12% online and 22% at listening events. Following the consultation, the recommendations arising from the consultation were published and are now being implemented.
Phase one of implementation commenced on 1 October 2018 when the National Directive on Commercial Contract Research Studies (jointly developed by NHS England, NHS Improvement, the Health Research Authority and the NIHR) came into force, setting out two initial requirements for all NHS service provider sites conducting commercial clinical research:
Firstly, all NHS sites, life science companies and/or CROs conducting commercial contract clinical research in the NHS are mandated to use an unmodified model site agreement (also known as model Clinical Trial Agreement, mCTA). These are nationally accepted contract terms which, when used without modification, will eliminate delays caused by contract negotiations and legal reviews for each NHS site delivering a study. They are also a required document for acquiring Health Research Authority (HRA) approval (combined governance, legal, ethics approvals). The full library of these ‘off the shelf’ contract templates was first introduced in 2013 yet have remained ‘optional’ until now.
Secondly, all NHS sites in England conducting commercial contract clinical research are also now mandated to use the NIHR standard costing methodology when contracting with life science companies and/or CROs. The standard methodology has also existed as an ‘optional’ tool for over a decade and provides a framework for transparent cost display and calculation to support swift local site budget negotiations. Mandating the use of the costing methodology means less variation when defining resource requirements across the country, better transparency in how that resource requirement is costed locally, and better predictability of overall study delivery costs. The content of the costing template and methodology has been reviewed and cross checked against commercial budget tool provider lists to identify gaps and has been aligned with the NHS National Tariff where possible.
The original costing tool was developed in Excel but, as of April this year, it has been superseded by a new digital (web-based) version known as the interactive Costing Tool (iCT). iCT better meets the needs of users by supporting the workflow for the costing process, creating an audit trail, and providing even greater transparency of costing negotiation and agreed costs at participating sites. This should make it quicker and easier to set up commercial studies in the NHS and crucially will underpin the next phase of changes.
Phase two of implementation, which is now underway, introduced a ‘review once and share’ approach through the concept of a single contract review process. This change will allow life science companies to negotiate the resource allocation required to deliver the trial (at any site) with one single National Coordinator. Once the resource allocation is agreed, all sites thereafter partaking in the trial would abide by that agreement and use the mandated costing tool (which allows for localization factors such as whether or not a provider has to outsource for specialist services) to price the study.
This will provide an effective, high quality, timely and efficient financial service, increasing the attractiveness of the NHS for research placement. The National Coordinator will communicate the NHS costing approach to negotiate full cost recovery, focusing on identification study requirements, associated timings and appropriate clinical and service support resource requirements. The plan is for the coordinators to have access to full study information, such as the Full Protocol or Clinical Investigational Plan, Laboratory Manual, Radiology Manual, Pharmacy Manual, e-CRF and training needs. Importantly, they have the authority to act in a national capacity, with defined accountability linked to NHS Provider standard contract, and are endorsed by NHS R&D leadership.
A number of NHS sites that are experienced in commercial research are currently testing the proposed process for a single contract review.
Step one has involved volunteer national coordinators from participating sites conducting an enhanced validation on a single study to better understand variation in site costs and training requirements for national coordinators. More than 30 commercial contract studies have supported this first phase and an independent impact analysis is now being completed using this information.
Step two commenced in July 2019, in which a small number of commercial studies are being closely supported to progress through the process. The third step will involve the assessment of the new process delivered at scale for all new studies, ensuring that the approach is sustainable and provides a high quality service which speed up costing negotiation and consistency for multi-center studies. It is anticipated that the final step, entering business as usual activity, will begin in early 2020.
A pool of National Coordinators is now being identified to undertake the cost review of a study on behalf of all sites. This role will ensure that there is nationwide consistency in our ways of working, negotiating and agreeing costs. This will define overall national study resource requirements separate to the assessment of the capacity and capability of each individual site.
Written down in black and white it seems like a perfectly logical set of changes, with clear benefits. A simplified commercial contract research costing review process will result in; less time negotiating costs and contracts with multiple sites; provide more consistency when defining resource and procedure requirements across the country; give transparency in how resource requirement is costed across the country; increased predictability of the overall costs to deliver a multi-site study; and reduced administration requirements.
But these are big changes and have required a significant shift in mindset for many. Consequently, implementation is being overseen by an advisory group which draws together representation from the life sciences industry, NHS organizations and R&D bodies, trade associations and regulators, to ensure stakeholder feedback is considered throughout implementation. Ongoing stakeholder focus groups are also being held to seek and act on arising feedback and learnings.
By simplifying and improving arrangements to set up and deliver research, we can support patients to receive the best care by speeding up access to new treatments. Mandated processes for the transparent set up of commercial contract research will help to eliminate uncertainties and delays through improved transparency and consistency for NHS providers and for the life sciences industry. This builds on the excellent reputation of the NHS, to attract more global clinical research from commercial companies, which serves to benefit patients, NHS providers and the wider UK economy and puts the UK in good stead for the future.
References
- https://www.nihr.ac.uk/life-sciences-industry/documents/NIHR%20CRN%20Impact%20and%20Value%20FINAL%20REPORT_vSTC_160908_FOR%20EXTERNAL%20USE.pdf