Select Committee on Science and Technology Appendices to the Minutes of Evidence


Memorandum submitted by Professor David J Kerr, Professor of Clinical Oncology, CRC Institute for Cancer Studies, University of Birmingham


1.1  Relevance of submission to the Inquiry

1.  David Kerr has been the Professor of Clinical Oncology in Birmingham since March 1992 and has been instrumental in establishing the new Institute of Cancer Studies at the University of Birmingham, which has a research staff of around two hundred clinical and basic scientists.

  2.  He has won several international prizes, has published more than 150 articles in peer-reviewed journals and has a competitive grant income of several million pounds.

  3.  He is Director of the CRC Clinical Trials Unit, one of the countries leading centres for the design, conduct and analysis of cancer trials. The main areas of research interest are in early drug development trials, multi-centre PIII trials in gastro-intestinal cancer and gene/immunotherapy therapy.

  4.  He chairs an Advisory Group that will report to the Department of Health in June 2000, on the optimal future strategic direction for NHS R&D investment in cancer.

1.2  The Infrastructure for cancer treatment and importance of research to the NHS

  5.  The UK tends to fare rather badly in international comparisons of cancer survival rates. Reviews have demonstrated wide variations in survival outcomes achieved by individual clinicians, hospitals and local and regional health authorities, and suggest a benefit of specialisation and specialist teams.

  6.  The available data suggests potential problems in variable practice and service delivery which thus prompted the Department of Health to publish a policy framework for commissioning cancer services. The Calman-Hine report (1994) proposed a broad framework which defined a network of cancer centres and units underpinned by continuing community care. This paper was not prescriptive, but was, rather, open to adaptation to local circumstance.

  7.  The drive to deliver high quality care, widely and equitably, has led to a renewed commitment to "evidence based" medicine within the NHS. It is widely recognised that adopting state-of-the-art comparative treatment protocols is necessary to reliably inform the management of future patients and that participation provides patients with access to the best current care options.

1.3  Current status of the UK's Cancer Research Portfolio

  8.  The UK Government provides funding for cancer research through the Research Councils and Department of Health and there is also a strong history of voluntary sector funding.

  9.  Oncology has a long-standing, multidisciplinary research culture and the benefit of strong and wide-ranging investment in basic science and clinical research. The United Kingdom Co-ordinating Committee for Cancer Research (UKCCCR) reports that there is a significant investment in basic and clinical cancer research from the public and charitable sectors.

  10.  Research funding in the UK is increasingly well co-ordinated, independently peer reviewed and directed towards addressing priority areas. The recent creation of the Cancer Funders Forum will further strengthen the position.

  11.  The current funding umbrella does not adequately cover the extra service and research support resources needed to treat patients in the context of clinical trials. The NHS clinical research effort is most vulnerable at the clinical interface.

1.4  Development of the cancer clinical trials portfolio

  12.  There are several different levels of UK "think tanks" that function to identify and prioritise the major questions for each of the different cancer speciality areas, and to develop and put forward the best practicable trial designs to address them. The process is geared toward filtering out the unworkable and the less important topics.

    —  The UKCCCR organises a series of site specific groups.

    —  There are a number of strong UK collaborative clinical groups that provide channels for new ideas, leadership, communication, feasibility testing and recruitment to trials.

    —  Membership of collaborative groups formed to conduct a specific trial or series of trials is generally decided by individual clinicians' willingness to participate and is usually managed by the CTO(s) responsible.

1.5  Interactions and partnership with the Pharmaceutical and Biotechnology Industry

  13.  The Pharmaceutical and Biotechnology Industry have active research programmes, ranging from early drug development trials through large randomised, international comparative studies into marketing studies. Participation in commercially sponsored studies is an important source of access to new compounds and external support for many oncology centres.

  14.  There is no doubt that access to a continued supply of new potential anti-cancer treatments via participation in early drug development trials is seen by patients and oncologists alike as one of the hall-marks of cutting edge cancer research within the NHS.

  15.  The NHS needs to provide a research environment capable of responding to industry needs for rapid turnaround and high quality data at reasonable cost in order to secure access to new compounds and large scale investment funding.

  16.  There are a number of small to medium sized, innovative, high quality research based biotechnology companies who face prohibitive costs in undertaking clinical trials for licencing purposes. There may well be opportunities for the formation of innovative partnerships that would potentially improve the viability and range of this research.

1.6  Early drug development and translational research

  17.  The public sector needs to support an independent, academic led, drug development trials portfolio.

  18.  The key to providing optimal cancer care for the NHS is to support the translation of our own basic science platform into trials of clinical and academic relevance.

  19.  In part, this is to retain our international competitiveness in basic research into the causes and mechanisms of cancer (against other European and US academic centres and multi national pharmaceutical companies).

  20.  There is genuine patient demand and need for access to novel, unlicensed agents in the context of rigorously conducted clinical trials. Although the chance of therapeutic benefit is small, most report that participation offers psychological and altruistic benefits.

  21.  These studies are necessarily intensive and demanding on clinical time, extra NHS services and the availability of multidisciplinary teams which include strong academic input.

  22.  It follows that this portfolio is best managed from within a few, geographically distributed "comprehensive" cancer centres that typically are associated with Medical Schools.

  23.  Additional NHS infrastructure is needed to meet the additional resource needs (ie technical, laboratory, pharmacy, radiology, nuclear medicine) of drug development trials originating in the public sector (eg from Cancer Institutes, Cancer Research Campaign, ICRF units).

1.7  The Cancer Trials Offices

  24.  This is the area in which there is most cooperation between the cancer research funding bodies. The UK has followed a worldwide trend in having evolved a number of dedicated centres that specialise in the design, management and analysis of clinical trials. There are a limited number of Clinical Trials Offices (CTO) that are subject to a regular process of peer review, and with the confirmed capacity and expertise to develop, coordinate and analyse UK and International multicentre trials.

  25.  There is also a demand for increased bio-statistical, IT and trial management expertise to support local research needs and projects. There are a number of small trials offices (funded predominantly by CRC) in large, metropolitan cancer centres. More small trials units, with statistical and IT support, are being created by Trusts.

1.8  Barriers to clinical research: recruitment and data quality

  26.  The main factors limiting the conduct of cancer research within the NHS, and the delivery of timely medical evidence are sub-optimal recruitment and patchy quality of data for the clinical trials that are undertaken.

  27.  It is clear that lack of dedicated time and resources for research are major barriers to the translation of clinical interest into recruitment and the delivery of high quality, timely data (Prescott et al, 1999). Fallowfield's survey of 357 UK cancer specialists published in 1997 reported that 99 per cent took part in trials, but only 25 per cent believed they were regularly entering £50 per cent of their eligible patients. This data indicates that the UK's research active community has considerable scope to increase recruitment given the necessary resources.

  28.  Clinical interest and support may be rallied by providing them with clinical support staff, easier call on any extra NHS service and treatment resources required by protocols, and improved access to the expertise of local and national Clinical Trial Offices (CTOs)

  29.   Hence the recent report from the NHS Cancer Working Group (Report on Strategic priorities in Cancer Research and Development, 1999) identified a primary strategic need to focus on providing support for the front line clinical researchers.

1.9  Overcoming barriers to the dissemination and adoption of clinical trial evidence

  30.  It is widely acknowledged that there is a gap between making new evidence available to the NHS and its incorporation into best clinical practice

  31.  The NHS Cancer Working Group report (1999) noted that there is no system for monitoring the delivery of care to see if effective therapies are being implemented and ineffective ones discontinued.

  32.  There is evidence to suggest that participation in trials facilitates the adoption of evidence based medicine. This is probably due in part, to the break down of any clinical barriers toward understanding and acceptance of the findings. Organisational and infrastructural adaptation during the trial may help cushion the impact of consequent changes in practice.

  33.  Thus a very important and effective route to get research findings rapidly into practice is by maintaining a cohesive UK-based research portfolio, thus training future generations of clinicians in the benefits of evidence based practice.

1.10  Summary

  34.  This country has an outstanding record of scientific innovation in cancer research, that rests on mutual support between the NHS, universities and bodies funding high quality R&D.

  35.  The cancer research community has effective networks in place for the identification, prioritisation and conduct of clinical research. The recent establishment of the Cancer Funders Forum will strengthen this position.

  36.  Fine tuning to fast track funding decisions and ethical approvals would be beneficial.

  37.  The National Health Service has the potential to provide an internationally recognised broad platform for the conduct clinical research and adoption of evidence based medicine.


  38.  The best way forward is a co-ordinated approach that will strengthen the UK Cancer research identity via integration to optimise the use of the existing research resources and joint investment in a centrally co-ordinated clinical network or "co-operative group".

  39.  There is no added value, or need, to establish a monolithic UK National Cancer Institute.

  40.  There is a need to develop closer working links between the "think tanks", research sponsors, clinical trial organisers and the clinical interface.

  41.  The priority should be to establish a new, co-ordinated network of clinical centres and provide the necessary research workforce and protected resources necessary to conduct trials as a mainstream activity in the NHS.

  42.  Such a network would map naturally onto the network currently being implemented for delivery of cancer services in the NHS under the Calman-Hine plan.

  43.  Major investment is needed to embed an infrastructure for research in NHS clinical centres and to encourage and support clinicians who wish to adopt clinical trials as a routine part of patient care.

  44.  In order to remove the major organisational barriers to cancer R&D in the NHS, reorganisation should address the provision of a trained workforce where most needed in trial-oriented clinics and improved access to support for meeting the major rate limiting excess service and treatment costs associated with individual protocols.

  45.  Research active clinical centres should be supported in the development of a structured, stable local research organisation capable of undertaking a rolling programme of trials and of interfacing effectively with research bodies.

  46.  At present NHS clinical centres control access to patients and data, but participation is a voluntary activity, largely without tangible rewards or accountability. Future investment in R&D infrastructure should be quality managed, with participating NHS clinical centres sharing more fully the responsibility for the success of trials in terms of meeting recruitment targets and adherence to protocol.

  47.  The public sector has a need to establish recognised mechanisms to link funding to performance and encourage the development of accredited clinical centres working to a recognised standard of research excellence.

  48.  These mechanisms should aim to facilitate the passage of new treatments from the lab to the clinic and create co-ordinating centres for Phase I, II and III clinical trials. The infrastructure needed to participate in cutting edge research and associated benefits (high quality cancer care, rapid take up of results) should be geographically distributed so as to be within reach of the majority of interested clinicians and patients.

  49.  The development of a highly trained and responsive research support network would provide an attractive platform for new research investment and partnership with industry.

  50.  There is the opportunity to bring together the key stake holders in cancer research under a single umbrella in order to create a "distributed" National Cancer Institute, that will retain existing funding sources, flexibility and ability to innovate and build on the nation's intellectual and infrastructural strengths. The "missing link" is a co-ordinated research infrastructure within the NHS. Addressing this key organisational development need offers great added value in terms of improving the efficiency and throughput of the entire research and development cycle in the UK.

7 April 2000

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