Product News
|
- 05/07/2007 12:00:00 - Infonetica Announce the Launch of Tissue Auditor Tissue Auditor is designed to meet the new regulatory requirements of handling human tissue samples. Tissue Auditor meets and exceeds these requirements while being able to be integrated into Infonetica's existing product offerings. learn more |
Turning the corner in UK clinical research
Dated: 09/01/2009 12:00:00
Dr Clare Morgan reviews the need for a consistent and performance-managed process for NHS study permission across England and offers an insight into how the NIHR Clinical Research Network will achieve this Turning the corner in UK clinical research
Dr Clare Morgan reviews the need for a consistent and performance-managed process for NHS study permission across England and offers an insight into how the NIHR Clinical Research Network will achieve this
A new system went live on November 18, 2008, introducing a consistent and streamlined process for gaining NHS clinical study permission in England. The go-live of the National Institute for Health Research Coordinated System for Gaining NHS Permission (NIHR CSP) marks the beginning of a transitional implementation and improvement process for the new system, which will continue until April 2009. This is a long awaited development, especially by the pharmaceutical, biotechnology and medical device industries, and the next 12 months will be a key period in reviewing the incremental impact of NIHR CSP on study start-up times. But can the new system support the UK in its bid to once again become a world-class centre for conducting commercial clinical research?
Few working in clinical research will not be aware of the need for such a system. The healthcare industry has always made a significant contribution to the UK, both through the conduct of its R&D programmes within the NHS but also in its economic contribution to the UK economy. In 2007, the UK pharmaceutical industry alone invested £4.2 billion in R&D, employed 73,000 people and was ranked first for its contribution to the UK’s trade surplus. High quality commercial research has benefited both patients and the NHS workforce by providing early access to state-of-the-art therapies and technologies.
Although the investment within the UK remains significant, a number of challenges are making the initiation and conduct of commercial clinical research in the UK increasingly difficult, notably:
• R&D approval and set-up times are too slow and bureaucratic to make the UK competitive
• Reduced cost effectiveness makes it difficult to compete with the rest of the world
• Poor delivery of UK studies.
These challenges have been escalating and in 2005, the McKinsey report on clinical research in the UK outlined the requirement for “a single system that reliably delivers distinctive quality and rapid access at reasonable cost”. In response, the government set out the direction in which NHS R&D should evolve over a five-year period to establish a vibrant, world-class environment for conducting and using NHS health research, detailed in Best Research for Best Health. Its strategic goals included the establishment of the NHS as an internationally recognised centre of research excellence; the attraction and retention of the best research professionals; and the strengthening and streamlining of systems for research management and governance.
The implementation of NIHR CSP is the most significant and newly delivered project within the NIHR programme to strengthen and streamline systems for research management and governance.
Rationalising NHS permission
Industry consistently feeds back that the biggest barrier to getting UK studies started in a timely manner is delays with NHS R&D submissions and approvals. Although some NHS Trusts review and approve studies in a consistent, streamlined and pragmatic manner, this is not universal and initiating a multi-centre study can be confusing, frustrating and costly. This obviously has the greatest impact on commercial organisations, which need to progress clinical studies in a rapid and cost-effective manner in order to meet pre-defined regulatory and licensing timelines.
The three key issues impacting on current processes for obtaining NHS permission are consistency, speed and predictability.
Consistency
To date there has been no national uniformity in application and review processes for NHS permission in England. Although there are excellent examples of best practice in implementing the Research Governance Framework within some R&D departments in the NHS, this has been open to wide interpretation, and has been further compounded by a lack of standard national timelines or targets for NHS sign off, leading to an unpredictable system, both in terms of duplicity and speed. This is a particular issue for multi-centre studies in which research governance checks are potentially duplicated in every participating Trust.
Speed
The lack of a time target for achieving NHS permission within England has been highlighted as out of line with the targets of 90 days and 60 days set by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Research Ethics Service (NRES) respectively. Coupled with the independent legal status of each NHS Trust, perhaps it’s not surprising that R&D departments want to assure Trust Boards that the study has been thoroughly reviewed and resource implication considered; both in terms of risk and cost.
The metrics collected by the Association of the British Pharmaceutical Industry (ABPI) for 2008 (annual retrospective data) demonstrate that the median time from R&D notification to sign off is 82 days, with the median time from first submission to first patient/visit now 187 days. These times have been steadily increasing since the data was first collected in 2005.
Predictability
Although predictability is closely coupled with consistency and speed, previous NHS permission systems have not enabled researchers to predict when studies will be fully approved and open to recruit patients. This has a significant impact on the predicted recruitment period for active patient enrolment and is a major issue for industry, which also has to contend with global competitive recruitment in many studies. Pressures on the timely completion of commercial clinical trials have meant that increasing start up times made the UK less attractive to conduct clinical research.
What is NIHR CSP and how is it different?
The NIHR CSP has been implemented to standardise and streamline the process for gaining NHS permission for clinical research studies in England. NIHR CSP ensures the relevant quality assurance and statutory requirements are met through the definition of a consistent and comprehensive set of NHS research governance checks for all new studies. It is intended to reduce approval times by conducting certain checks only once for multi-centre studies and providing a single system for processing and reviewing applications for NHS permission, coordinated by a central CSP Unit and with local processes supported through NIHR Comprehensive Local Research Networks (CLRNs), with dedicated staff embedded within Trusts. It is essential to note that it is currently only available to studies that are eligible for the NIHR Portfolio and studies funded through NIHR Biomedical Research Centres and Units, and Collaborations for Leadership in Applied Health Research and Care (CLAHRCs). Although all industry studies are potentially eligible, they must be adopted through a standardised Industry Adoption Process in order to gain access to NIHR CSP.
The delivery of NIHR CSP to go-live status was – unsurprisingly due to its complexity – not entirely without its challenges. While the system uses the Integrated Research Application System (IRAS) as its entry point, an entirely new information system had to be created to bring together all the permission and approval paths. The information system, CSP ReDA, took more than 18 months to develop by a specialist team from NIHR Clinical Research Network (NIHR CRN) working closely with Infonetica and other key stakeholders. Input from R&D managers, CLRN research management and governance managers, researchers and UKCRC partners was critical in ensuring a robust system was developed which met the requirements of the NHS organisations and the Research Governance Framework.
NIHR CSP is much more than just an information system and buy-in from the research management community will be key to its successful implementation. The NIHR CRN has been working closely with the core teams within each of the 25 CLRNs to train super-users and subsequently users to employ the new information system. The process is supported by a set of standard operating procedures and operating guidelines to ensure NIHR CSP is conducted consistently across all NHS Trusts within each CLRN.
The staffing model to support NIHR CSP varies across each CLRN, but each NHS organisation has signed up to a membership agreement with their CLRN which states they will work to the defined process; a delegated Trust signatory has also been identified for each organisation. NIHR CSP does not change the requirement for each NHS organisation to confirm permission for new research to be carried out or change the duty of care placed on NHS organisations when carrying out studies. Only a very small number of Trusts – four out of some 400 NHS organisations in England – have flagged they are not yet able to implement NIHR CSP and these are listed on the NIHR CRN website. From April 2009, NHS organisations will need to use NIHR CSP exclusively for NIHR portfolio studies in order to continue receiving NIHR Clinical Research Network funding.
Demonstrating improvement in study set up times is critical and a series of time clocks have been incorporated into the NIHR CSP process, linked to a set of key performance indicators to allow NIHR CRN to monitor the impact on NHS permission times in England. The introduction of a new system and staffing infrastructure, through the CLRNs, is a major change for NHS R&D management to take on board and incremental improvements in approval times are expected until the end of implementation in April 2009. It is then anticipated that clear improvements in NHS permission times can be routinely demonstrated and this will be reflected in the ABPI metrics published in 2010 (annual retrospective data).
The future
Go-live of NIHR CSP is a significant landmark in the delivery against the Best Research for Best Health strategy. The process will be reviewed and refined on an ongoing basis and this will be a collaborative process to ensure that NIHR CSP is optimised for all key stakeholders.
Significant improvements in NHS permission and study set-up times must be an outcome of the introduction of NIHR CSP, however it will only be the demonstration of delivery against the key performance indicators that will convince researchers the tide is turning.
As Dr Richard Tiner, Medical Director of the ABPI stated, “Only time will tell how significant today [November 18] will be for the future of UK clinical research but I firmly believe it will turn out to be a very significant day.”
The final words should be attributed to Professor Sally C Davies, Director General of Research and Development at the Department of Health, who said: “The new system will minimise the administrative burden for the NHS and for researchers. This will lead to benefits for the NHS and for commercial and non-commercial investigators alike. The launch of the coordinated system marks another important step in realising our ambition of making this country the most attractive place in the world for science and innovation.”
Dr Clare Morgan is Director of Industry at the NIHR Clinical Research Network Coordinating Centre
Dr Clare Morgan reviews the need for a consistent and performance-managed process for NHS study permission across England and offers an insight into how the NIHR Clinical Research Network will achieve this
A new system went live on November 18, 2008, introducing a consistent and streamlined process for gaining NHS clinical study permission in England. The go-live of the National Institute for Health Research Coordinated System for Gaining NHS Permission (NIHR CSP) marks the beginning of a transitional implementation and improvement process for the new system, which will continue until April 2009. This is a long awaited development, especially by the pharmaceutical, biotechnology and medical device industries, and the next 12 months will be a key period in reviewing the incremental impact of NIHR CSP on study start-up times. But can the new system support the UK in its bid to once again become a world-class centre for conducting commercial clinical research?
Few working in clinical research will not be aware of the need for such a system. The healthcare industry has always made a significant contribution to the UK, both through the conduct of its R&D programmes within the NHS but also in its economic contribution to the UK economy. In 2007, the UK pharmaceutical industry alone invested £4.2 billion in R&D, employed 73,000 people and was ranked first for its contribution to the UK’s trade surplus. High quality commercial research has benefited both patients and the NHS workforce by providing early access to state-of-the-art therapies and technologies.
Although the investment within the UK remains significant, a number of challenges are making the initiation and conduct of commercial clinical research in the UK increasingly difficult, notably:
• R&D approval and set-up times are too slow and bureaucratic to make the UK competitive
• Reduced cost effectiveness makes it difficult to compete with the rest of the world
• Poor delivery of UK studies.
These challenges have been escalating and in 2005, the McKinsey report on clinical research in the UK outlined the requirement for “a single system that reliably delivers distinctive quality and rapid access at reasonable cost”. In response, the government set out the direction in which NHS R&D should evolve over a five-year period to establish a vibrant, world-class environment for conducting and using NHS health research, detailed in Best Research for Best Health. Its strategic goals included the establishment of the NHS as an internationally recognised centre of research excellence; the attraction and retention of the best research professionals; and the strengthening and streamlining of systems for research management and governance.
The implementation of NIHR CSP is the most significant and newly delivered project within the NIHR programme to strengthen and streamline systems for research management and governance.
Rationalising NHS permission
Industry consistently feeds back that the biggest barrier to getting UK studies started in a timely manner is delays with NHS R&D submissions and approvals. Although some NHS Trusts review and approve studies in a consistent, streamlined and pragmatic manner, this is not universal and initiating a multi-centre study can be confusing, frustrating and costly. This obviously has the greatest impact on commercial organisations, which need to progress clinical studies in a rapid and cost-effective manner in order to meet pre-defined regulatory and licensing timelines.
The three key issues impacting on current processes for obtaining NHS permission are consistency, speed and predictability.
Consistency
To date there has been no national uniformity in application and review processes for NHS permission in England. Although there are excellent examples of best practice in implementing the Research Governance Framework within some R&D departments in the NHS, this has been open to wide interpretation, and has been further compounded by a lack of standard national timelines or targets for NHS sign off, leading to an unpredictable system, both in terms of duplicity and speed. This is a particular issue for multi-centre studies in which research governance checks are potentially duplicated in every participating Trust.
Speed
The lack of a time target for achieving NHS permission within England has been highlighted as out of line with the targets of 90 days and 60 days set by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Research Ethics Service (NRES) respectively. Coupled with the independent legal status of each NHS Trust, perhaps it’s not surprising that R&D departments want to assure Trust Boards that the study has been thoroughly reviewed and resource implication considered; both in terms of risk and cost.
The metrics collected by the Association of the British Pharmaceutical Industry (ABPI) for 2008 (annual retrospective data) demonstrate that the median time from R&D notification to sign off is 82 days, with the median time from first submission to first patient/visit now 187 days. These times have been steadily increasing since the data was first collected in 2005.
Predictability
Although predictability is closely coupled with consistency and speed, previous NHS permission systems have not enabled researchers to predict when studies will be fully approved and open to recruit patients. This has a significant impact on the predicted recruitment period for active patient enrolment and is a major issue for industry, which also has to contend with global competitive recruitment in many studies. Pressures on the timely completion of commercial clinical trials have meant that increasing start up times made the UK less attractive to conduct clinical research.
What is NIHR CSP and how is it different?
The NIHR CSP has been implemented to standardise and streamline the process for gaining NHS permission for clinical research studies in England. NIHR CSP ensures the relevant quality assurance and statutory requirements are met through the definition of a consistent and comprehensive set of NHS research governance checks for all new studies. It is intended to reduce approval times by conducting certain checks only once for multi-centre studies and providing a single system for processing and reviewing applications for NHS permission, coordinated by a central CSP Unit and with local processes supported through NIHR Comprehensive Local Research Networks (CLRNs), with dedicated staff embedded within Trusts. It is essential to note that it is currently only available to studies that are eligible for the NIHR Portfolio and studies funded through NIHR Biomedical Research Centres and Units, and Collaborations for Leadership in Applied Health Research and Care (CLAHRCs). Although all industry studies are potentially eligible, they must be adopted through a standardised Industry Adoption Process in order to gain access to NIHR CSP.
The delivery of NIHR CSP to go-live status was – unsurprisingly due to its complexity – not entirely without its challenges. While the system uses the Integrated Research Application System (IRAS) as its entry point, an entirely new information system had to be created to bring together all the permission and approval paths. The information system, CSP ReDA, took more than 18 months to develop by a specialist team from NIHR Clinical Research Network (NIHR CRN) working closely with Infonetica and other key stakeholders. Input from R&D managers, CLRN research management and governance managers, researchers and UKCRC partners was critical in ensuring a robust system was developed which met the requirements of the NHS organisations and the Research Governance Framework.
NIHR CSP is much more than just an information system and buy-in from the research management community will be key to its successful implementation. The NIHR CRN has been working closely with the core teams within each of the 25 CLRNs to train super-users and subsequently users to employ the new information system. The process is supported by a set of standard operating procedures and operating guidelines to ensure NIHR CSP is conducted consistently across all NHS Trusts within each CLRN.
The staffing model to support NIHR CSP varies across each CLRN, but each NHS organisation has signed up to a membership agreement with their CLRN which states they will work to the defined process; a delegated Trust signatory has also been identified for each organisation. NIHR CSP does not change the requirement for each NHS organisation to confirm permission for new research to be carried out or change the duty of care placed on NHS organisations when carrying out studies. Only a very small number of Trusts – four out of some 400 NHS organisations in England – have flagged they are not yet able to implement NIHR CSP and these are listed on the NIHR CRN website. From April 2009, NHS organisations will need to use NIHR CSP exclusively for NIHR portfolio studies in order to continue receiving NIHR Clinical Research Network funding.
Demonstrating improvement in study set up times is critical and a series of time clocks have been incorporated into the NIHR CSP process, linked to a set of key performance indicators to allow NIHR CRN to monitor the impact on NHS permission times in England. The introduction of a new system and staffing infrastructure, through the CLRNs, is a major change for NHS R&D management to take on board and incremental improvements in approval times are expected until the end of implementation in April 2009. It is then anticipated that clear improvements in NHS permission times can be routinely demonstrated and this will be reflected in the ABPI metrics published in 2010 (annual retrospective data).
The future
Go-live of NIHR CSP is a significant landmark in the delivery against the Best Research for Best Health strategy. The process will be reviewed and refined on an ongoing basis and this will be a collaborative process to ensure that NIHR CSP is optimised for all key stakeholders.
Significant improvements in NHS permission and study set-up times must be an outcome of the introduction of NIHR CSP, however it will only be the demonstration of delivery against the key performance indicators that will convince researchers the tide is turning.
As Dr Richard Tiner, Medical Director of the ABPI stated, “Only time will tell how significant today [November 18] will be for the future of UK clinical research but I firmly believe it will turn out to be a very significant day.”
The final words should be attributed to Professor Sally C Davies, Director General of Research and Development at the Department of Health, who said: “The new system will minimise the administrative burden for the NHS and for researchers. This will lead to benefits for the NHS and for commercial and non-commercial investigators alike. The launch of the coordinated system marks another important step in realising our ambition of making this country the most attractive place in the world for science and innovation.”
Dr Clare Morgan is Director of Industry at the NIHR Clinical Research Network Coordinating Centre
source: Clinical Discovery