House of Commons - Science and Technology

Select Committee on Science and Technology Sixth Report

CANCER RESEARCH

59. Basic cancer research attempts to answer questions about the nature of cancer at a molecular and cellular level. Epidemiology and public health research seek to understand the causes and distribution of cancers at a population level and to give information on the effectiveness of treatment. Translational research seeks to take the new insights provided by basic research and from these to develop new therapeutic techniques. Clinical research tests the efficacy of new experimental therapies by using them in the clinic and comparing them with existing treatments. Each of these types of research is undertaken in the UK. Basic research is generally carried out in universities and in cancer institutes throughout the country. In the UK, the majority of these institutes are funded by cancer research charities.

Research into the Causes and Nature of Cancer

60. Basic cancer research into the causes and nature of cancer is an attempt to gain a better understanding of the molecular basis of malignancy. This research is laboratory-based and considers differences between cancer and normal cells, including the processes of cellular growth and division and the biological molecules involved. It looks at the nature and functions of genes and gene products and the molecules and mechanisms involved in cellular control, and the mechanisms controlling DNA replication, repair and orderly cell death.[83]

61. The most important current developments in basic research for long-term cancer solutions may come from basic research into genetics and genomics — research which is not specifically aimed at cancer. The Human Genome Project (HGP), as Professor McVie, Director General of the Cancer Research Campaign (CRC), told us, will result in a better understanding of the genetics of cancer: "This is a very exciting time. Whether the Human Genome delivers cancer genes within 10 or 25 years, the Human Genome Project will deliver cancer genes" (our emphasis).[84] Indeed, witnesses were unanimous in their belief that the HGP would have a major impact on cancer gene discovery.[85]

62. Advances in genetics and genomics have enabled cancer researchers to take new approaches to the identification of abnormal genes. Cancer researchers, including those at the Institute of Cancer Research (ICR), are already using information from the HGP to search for abnormal genes in a systematic fashion. One example of such research is the Cancer Genome Project. As we heard during our visit to the ICR and the Royal Marsden Hospital, the identification of abnormal cancer genes has been a major aim of cancer researchers for the last 20 years or so. The Cancer Genome Project, a collaboration between the ICR and the Sanger Centre, needs powerful bioinformatics systems, large and powerful machine resources, tumour and other tissue from patients and a wealth of knowledge about cancer. The project, which is expected to take a decade to complete, is funded largely by The Wellcome Trust which has committed £12 million, with another million coming from the ICR. There has been no funding from the Government for the project.[86] The UK is a significant partner in the HGP (about a third of the results released to date from the HGP have come from the Sanger Centre at Cambridge) and is therefore well-placed to ensure that it is well exploited for the benefit of biomedical science. This opportunity must not be missed.

63. The ICR told us that there was a chronic shortage of resources for bioinformatics, (that is processing of large amounts of biological data) which are essential when dealing with data sets of the size of the human genome sequence. This is a concern which was reiterated by other witnesses including Sir Paul Nurse, Director General of the ICRF, and Professor Ponder.[87] This shortage inevitably constrains research progress. We are concerned that in the UK there are shortages of skilled personnel in key areas of science — such as bioinformatics. We recommend that the Government identify and remedy these skill shortages.

64. Witnesses agreed that basic cancer research in the UK is of a very high standard.[88] This opinion is supported by many leading cancer researchers whom we met in the USA, Canada and Finland. Sustaining this quality cannot, however, be taken for granted. Many of the leading cancer researchers we met overseas either originated or trained in the UK. That so many of them told us they had left the UK because of the poor state of research infrastructure or the low level of salaries here indicates the vulnerability of the cancer research base to which a number of witnesses in the UK drew attention.[89]

Drug Discovery

65. Part of the process of basic cancer research is the identification of target molecules for drug development. These targets may be the regulatory molecules and enzymes involved in the cellular proliferation associated with cancer or the genes themselves. Drugs can be developed which will act against these newly identified targets. This can be done either by designing molecules which will bind with a specific target molecule or by screening a large number of potential candidate molecules in the hope that one of them interacts with the target and modifies it or blocks its actions. The CRC has invested in high-quality chemistry equipment such as combinatorial chemistry and high-throughput screening using robotic techniques in four UK centres, but screening for such lead compounds in the UK is mainly performed in the private sector.[90] By contrast, in the United States, the federally-funded National Cancer Institute (NCI) regularly screens newly discovered compounds for possible application as cancer drugs.[91] Canada too maintains a National Cancer Institute but in this case, it is funded by the voluntary sector.[92]

Translational Research

66. Today's cancer treatments are largely based on basic cancer research which was performed 20 to 30 years ago. Similarly, more recent advances in the understanding of the nature and causes of cancer can be expected to yield new treatments over the next few decades. Moving from understanding the problem to generating a solution through translational research is a complex and often lengthy scientific and clinical task.

67. Good translational cancer research is difficult to do and requires high quality, well-supported interdisciplinary research teams which enable close co-operation between laboratory scientists and clinical scientists treating patients.[93] On our visits to cancer research centres in the UK and in Canada, Finland and the USA, this message has been repeated many times. The ICRF told us that translational research is "impeded by the difficulties in carrying out the interdisciplinary work required" and that "non-clinical cancer research and the treatment of cancer are distinct expertises and the integration of theory and practice requires an investment of time that practising clinicians working within the demanding NHS environment often do not have to spare".[94]

68. A large new translational research centre is currently being established at Cambridge University which will bring together resources from the MRC, the CRC and the ICRF. Professor Ponder, who is leading the project, told us that it is proving difficult to attract and keep the best scientists for a number of reasons, including the internationally uncompetitive level of scientific salaries in the UK. He also believed that clinical scientists could be deterred from working in the UK by a fear that they would not be able to devote enough time to research as they might become "drowned in providing the NHS service".[95]

69. The complicated and long-term nature of translational research means that judgements of scientific performance on the basis of short-term measurements, through processes such as the research assessment exercise (RAE), may act as a disincentive. Professor Ponder told us that set-backs and disappointments are inevitable in translational research projects.[96] The Breast Cancer Campaign too is concerned that "translational research is less glamorous than, for example, cloning genes and less likely to provide definitive results in a finite time period".[97] The CRC agreed and suggested that translational research, which often involves "cross-discipline and cross-department interactions, needs to be given a higher status particularly in the universities and in the Research Assessment process so that it is not considered a 'second class' activity".[98] Policies such as those of the CRC and the IRCF, of funding institutes for longer-term stability, allow scientists to focus on longer-term objectives. We recommend that assessment of research quality and provision of research funding in the clinical and translational arenas take account of their long-term nature and gives due recognition to these important activities, particularly in the field of oncology.

70. The ICRF told us that, even though "the knowledge of cancer biology is increasing to the point where full-scale translation to advances in clinical practice is now possible on a widespread basis" there is "an insufficient number of research clinical oncologists and cancer surgeons to effect this transition".[99] We heard similar sentiments on each of our visits to UK cancer research centres.[100] Sir Paul Nurse told us that, in respect of translational research, the Americans "do it rather better" and that "there is a greater tradition ... of clinicians working next to basic scientists" in the USA, a fact which we witnessed first-hand when we visited the NCI.[101] We agree. Shortages in skilled staff risk making translational research a major bottleneck in the process of cancer research in the UK. Government must take this problem seriously. We recommend that the Government and the National Cancer Director ensure that clinical research scientists working in translational research have sufficient time available, away from their NHS responsibilities, to allow them to carry out research. (We pursue this issue in para 156).

Treatment and Clinical Trials

71. Once a new compound or treatment has been identified as potentially beneficial to patients with a particular condition, the treatment must at some stage be introduced to humans. Clinical trials are used to evaluate new treatments (or modified forms of existing treatments) by testing them in the clinic to compare their efficacy and toxicity profiles with those of established therapies. They usually follow the format of randomised controlled trials (RCTs). In RCTs, a suitable group of subjects is identified and split randomly into 'experimental' and 'control' groups. The experimental group receives the treatment under investigation. The control group receives the best known treatment to date. Clinical trials are categorised into four phases.

72. Phase I clinical trials are intended to test the new treatment for safety and to determine a safe dose. These trials are preceded by studies in animals to determine toxicity profiles and suitable dose levels. Once a safe dose is established in animals, in the case of most new medicines phase I trials are usually undertaken in normal, healthy volunteers. It would be unethical to introduce untested cytotoxic cancer drugs into healthy humans so for cancer, phase I studies are carried out in cancer patients who have failed to respond to other treatments. They are intended to determine the maximum tolerated dose and to characterise drug-related side-effects. In phase II trials, evidence is sought that the new treatment is effective. Phase III trials test whether the new treatment is better than existing treatments. New drugs or other new therapeutic techniques are often more expensive than the existing available treatment so it is important that, before they are licensed, new drugs are proven to be more effective than existing therapies.[102]

73. After a new treatment is licensed it remains important to monitor its effectiveness and safety. Clinical trials can only be carried out in a limited group of patients. Once a treatment is licensed and marketed its widespread use may lead to the identification of problems which could not have been identified at phase III. Phase IV studies are post-marketing surveillance of new therapies performed to ensure that they remain safe and effective when in widespread use. They may identify certain groups of patients who may react adversely.

RECRUITMENT OF PATIENTS

74. All clinical trials require the recruitment of patients to participate. Many would prefer not to participate and to receive the standard treatment. However, some cancer patients fail to respond to the standard available treatment or are aware that it does not offer a certain cure and so are often willing to participate as subjects for research into new and possibly better treatments.

75. Many witnesses told us that cancer patients who participate in clinical trials do better than other patients receiving the same treatment outside clinical trials, and suggested that this was a result of the strict adherence to protocols that trials require, and increased levels of monitoring, support and follow-up care.[103] The evidence we heard is also supported by published studies. In the UK over 80 per cent of child cancer patients, who are usually treated in specialist childhood cancer centres, are entered into clinical trials as a result of close collaboration between childhood cancer physicians and the relative rarity of childhood cancers.[104] Childhood cancers are however relatively uncommon: they represent 1 in 200 of all cancers. The Government has identified the high proportion of child cancer patients in clinical trials as a strength in the UK cancer health care system.[105] We agree. Not only does participation in a trial improve the average patient outcome, but the more subjects there are in a trial, the more reliable the results of those trials and the more quickly an outcome is reached. This in turn means that better drugs and therapeutic techniques reach the market more quickly. Currently less than 5 per cent of adult patients with solid tumours are entered into trials.[106] The Department of Health's own working group on cancer research has acknowledged that recruitment of patients into clinical trials is poor and that this undermines the development of evidence-based cancer care in the NHS.[107] We asked the Minister whether she had a target figure for patients entering trials. She told us that "We are not at the stage of being able to specify a particular target" but she agreed that "we can and must increase the number of patients going into trials".[108] Increasing the number of adult cancer patients entering clinical trials must become a high priority. We recommend that the Government sets challenging and specific targets for the proportion of eligible adult cancer patients entering clinical trials for all the most common cancers.

Informed Consent

76. Patients can only be enrolled onto a clinical trial if they give their consent. They must also be provided with complete information regarding the trial and the implications that participation will have for them. We have heard of one instance when a patient had been enrolled in a trial without any such prior information and without her signed consent.[109] While this is likely to be an unusual occurrence, any system which allows even accidental enrollment into a clinical trial without informed consent is failing the patients and, in the long run, likely to reduce patient co-operation in clinical trials. We recommend that stronger safeguards are put in place to ensure that informed consent is obtained from all patients before enrollment into a clinical trial.

77. Giving full information when seeking consent is not as simple as providing a leaflet and asking for a signature. Mrs O'Donoghue of Cancer Help, Preston, told us that "it is important that patients are taken as partners in their own care... It is impossible for patients to give informed consent if they are not treated as equal partners with honesty. They actually then become a partner in their own care".[110] Giving information to patients about participation in a cancer clinical trial is a complex business since patients are often stressed about their diagnosis and may feel pressured to agree. Counselling may be necessary, possibly on more than one occasion with different professionals. We recognise that this activity puts increasing pressure on the time of cancer doctors but this cannot and should not be avoided. There is an important rôle here for research nurses who can share some of the counselling and can also help to ensure that the patients do not feel pressured to participate. There is also an important rôle for the voluntary sector. Many voluntary cancer support groups, often run by cancer patients and their families, have the experience and expertise to advise patients on such matters, away from the pressures of the clinical environment. We recommend that the Government reviews NHS procedures for obtaining patients' informed consent for participation in clinical trials, including increased use of research nurses and the voluntary sector.

ACCESS TO CLINICAL TRIALS

78. For many cancer patients, enrollment in a clinical trial for a new treatment for their particular condition may offer the prospect of an enhanced outcome. Cancer patients are increasingly well-aware, perhaps through use of the world wide web, that clinical trials for new and possibly better treatments are being conducted but, at the moment, it is very difficult for patients to enter themselves into clinical trials. They have to know not only that a trial is open but also whether or not they meet the clinical eligibility criteria. They would also need a referral to a participating research centre. As a result of these difficulties, whether a patient is given the opportunity to participate in a clinical trial is often dependent on their consultant.

79. The Department of Health, the MRC and cancer research charities are currently co-operating in the development of a national register, detailing all publicly or charitably funded clinical trials. Sir John Pattison, the Director of R&D for the NHS, told us that this was intended to inform researchers and it was also proposed that it might be used to inform the public "who might want to volunteer to take part in those trials".[111] A comprehensive database of UK clinical trials for cancer treatments (including those funded by industry), accessible to the public and health care professionals alike, would allow patients to volunteer directly to the investigators or, preferably, through referral by their GP or local specialist. In the United States, the NCI operates Cancernet — an on-line database of cancer clinical trials going on all around the world.[112] For US funded trials the data are comprehensive and explains the trials in language suited for both health professionals and patients. The Cancernet database is a good model which the UK could adopt.

80. We recommend that the Government produce and maintain a publicly accessible, comprehensive database of all clinical trials, including those funded by industry, currently recruiting patients, using Cancernet as a model. This will need to be advertised widely. The Government must also encourage GPs and hospital consultants as well as healthcare organisations such as community health councils to advise patients of available trials relevant to their condition.

THE NATIONAL HEALTH SERVICE AS A RESEARCH ENVIRONMENT

81. The NHS represents, potentially, the ideal research environment for conducting large-scale clinical trials. The Department of Health told us that the structure, organisation and funding of research for the NHS enables it to "host, support, initiate and participate in basic, clinical and applied research offering a unique opportunity to all involved in cancer R&D for multi-centre trials. The participation of NHS clinicians in research should allow the findings from research to be translated into patient care more quickly".[113] The CRC told us that "The NHS is ideally placed, particularly through the large cancer centres, to conduct good clinical trials based on networking and goodwill throughout the UK".[114] We agree. The structure of the NHS means that it is an ideal environment in which to conduct clinical research. However, as the CRC also told us, "the number of adult patients entered into randomised controlled trials (phase III) in the main oncology centres is less than 10 per cent and overall less than 5 per cent".[115]

82. Our concerns that the NHS is failing to exploit its full potential as a first-class research environment for clinical cancer research were endorsed by the Association of the British Pharmaceutical Industry (ABPI). The ABPI's membership includes multi-national pharmaceutical companies which perform research all over the world and it is therefore in a good position to make international comparisons. The ABPI told us that "the UK is unable to provide as comprehensive a cancer service in comparison with many of our Western neighbours. Medical oncologists are seeing three to four times as many patients per annum in the UK than their European colleagues. The strain on the system leads to a lack of motivation to deal with the extra work which clinical trials entail".[116] The ABPI also claims that there are only a few notable UK centres of excellence in cancer with the necessary infrastructure to perform clinical trials to the necessary standard.[117] AstraZeneca, a large, UK-based pharmaceutical company with major cancer interests, reported "a noted lack of resource to conduct the main body of clinical trials, which require intensive monitoring, and support for the clinician in terms of dedicated pharmacy, clerical, nursing and other staff. This is a major deficit in the UK".[118] They also told us that "if you are using very few, say, of the modern cytotoxics and modern agents then you are not used to managing them. Then when you are asked to do a clinical trial, particularly with inadequate infrastructure, you run the risk of unexpected side-effects and sometimes fatalities. No-one is going to want to do studies in that environment".[119]

83. Moreover, concerns about the NHS as a place to do cancer research are not limited to the pharmaceutical industry. The ICRF told us that "the inadequacy of the NHS infrastructure is a major problem for clinical research".[120] CancerBACUP told us that "too few clinical trials take place in the NHS because of a shortage of staff and inadequate facilities".[121] Many witnesses highlighted similar concerns over shortages in research nurses and data managers. Professor Lister told us that "until we have those people and until we have a large infrastructure to go with it... we will be hampered in our ability to conduct excellent clinical research".[122] Professor Dalgleish of St. George's Hospital said that "the most important thing to correct in the British hospital system is the infrastructure to do clinical trials".[123] Professor Ponder of Cambridge University stated that "the main barrier [to research] is infrastructure".[124] Professor Kaye of Glasgow University argued that "inadequate numbers of staff, lack of funding for new agents, and inadequate investment in equipment means that UK clinical cancer research inevitably struggles to compete with activity elsewhere in Europe and the USA".[125] Similarly, Professor Kerr of Birmingham University told us that "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".[126] The Royal College of Radiologists told us that "what inhibits trial entry is inadequate infrastructure both for data collection and IT and too few medical staff who already have overwhelming clinical workloads".[127]

84. Such concerns regarding the inadequate state of the NHS infrastructure, and its impact on clinical research, have been acknowledged by the Department of Health. The Department's own review of strategic priorities in cancer R&D highlighted the infrastructure that is essential to research as the highest priority for NHS R&D investment.[128] The Minister agreed that the need for NHS infrastructure improvements was a barrier to increasing the number of patients entering clinical trials.[129]

The Supply of Oncologists

85. There are 134 consultant medical oncologists and about 350 consultant clinical oncologists working in the UK.[130] The National Cancer Director told us that there are sufficient numbers now in training to increase the total number of consultant oncologists by 40 per cent in the next four years. Within this total the number of medical oncologists is expected to double.[131] We welcome the planned increase in numbers of oncology consultants but note that, in comparison with other countries, British oncology specialists will continue to have a heavy clinical workload.[132] Reducing the patient workload of each consultant oncologist would improve cancer treatment and make it easier for consultants to find time for research. The reduction in patient workload and consequent increase in research can, however, only be achieved if the NHS and universities create the necessary numbers of permanent clinical and academic posts for the newly qualified consultants to occupy. Adequate numbers of junior medical and other support staff will also be needed. We recommend that the Government significantly increases the numbers of oncologists in training, setting a ten-year target to ensure that there are sufficient numbers of consultant oncologists to bring patient workload into line with that in comparable countries. We also recommend that the Government ensures that, as the new consultants qualify, new academic and clinical consultant posts are created.

86. Medical oncology is to a large extent a research led clinical specialty. More than half of the medical oncology consultants are employed by universities and almost all have research degrees, either an MD or a PhD. The problems of a clinical academic career are far from unique to medical oncology. While clinical academics are responsible for clinical research and teaching both at an undergraduate and postgraduate level, they also have heavy commitments in terms of treating patients. In addition, the majority of NHS-employed medical oncologists do a significant amount of clinical research. Building a career in medical oncology often includes some time spent doing research, including training for higher degrees. On our visits to cancer research centres around the UK we heard from young medical oncologists setting out on careers combining cancer research and cancer treatment that the research element of their work was holding back their clinical career progression. At present the clinical training in medical oncology includes 4 years as a specialist registrar after a number of years as a more junior doctor involved in general professional training and after obtaining membership of the Royal College of Physicians. This period of 4 years is extended considerably by the time spent doing research, usually three years. As in all other medical specialties, this is a serious disincentive for young doctors seeking to build a career in research. Since nearly all good quality medical oncology treatment is at the cutting edge of the latest developments in the field, it is highly desirable that the research culture in the discipline is maintained and enhanced. The current arrangements for career development and remuneration in academic medical oncology represent a real disincentive to bright young medical graduates following a career in medical oncology. We recommend that the level of remuneration for academic medical careers should be reviewed to ensure that they are competitive with NHS-based careers. We further recommend that, in addition to the specialist training requirement, oncologists should be encouraged to undertake a period of research.

Other Infrastructure Required for Research

87. Research nurses are a critical element in the delivery of safe, well-conducted clinical trials. Chemotherapy can be hazardous and needs to be delivered by highly trained nurses. New, less well-characterised, experimental cytotoxic agents that are commonly used in clinical trials amplify these hazards and the standard of the care and monitoring must therefore be the highest possible. Research nurses are also needed to counsel patients entering trials. Research work cannot be said to be part of the standard activities of cancer nurses. We have received extensive evidence regarding the importance of the provision of specialist cancer research nurses, and that the supply of such nurses is far too low to be able to carry out a desirable volume of clinical trials.[133]

88. Clinical trials require rigorous collection and recording of data gathered from patients and their health professionals. Large trials require the management of complex data sets, and the provision of high quality data to trial investigators. Such data management is best performed by trained professionals with the latest information technology (IT) equipment. Data managers for cancer clinical trials are also in short supply in the NHS, as is the necessary IT equipment. This matter has been brought to our attention on a number of occasions during our visits to UK cancer research centres.[134]

89. Pay and career structures for essentially non-medically qualified professionals, notably medical laboratory scientific officers and radiographers, are inadequate and enhanced training and recruitment programmes are required. Without such staff effective treatment is impossible.

90. Beyond the dedicated research-specific staff required, clinical research also places greater demands on services that should routinely be available in NHS cancer treatment centres. These include radiology and other diagnostic imaging technologies (eg. CT, ultrasound , PET and MRI scans), histopathology, pharmacy, radiotherapy and secretarial support. Unless these services are significantly boosted over and above that which is needed for routine cancer care, clinical trials cannot take place. Again, we have received evidence that these treatment support services are not widely available at a level sufficient to support the needs of clinical research over and above the routine NHS service load.

91. The Department of Health told us that it is "working to improve the infrastructure for cancer clinical trials in the UK" and that "detailed proposals are being worked up and will be pursued through the Cancer Research Funders' Forum" to improve the infrastructure for cancer clinical trials.[135] There is widespread agreement that the poor state of the infrastructure for cancer treatment and research in the NHS is a serious barrier to clinical research. The Government must act quickly to address this through investment in the necessary staff, training, equipment and buildings.

ETHICAL APPROVAL

92. All clinical trials must be ethically approved. This means that the protocols and objectives of the trial must be examined by a local research ethics committee (LREC) to ensure that patients participating in trials are not subject to unnecessary procedures or risks and are given a high standard of treatment. This is a widely accepted critical safeguard for the rights of patient volunteers where failure to provide the best possible treatment could risk the life of the patient and unnecessary procedures could be associated with unpleasant, even life-threatening side-effects. Ethical approval is also needed for the location of the institution performing the trial, the investigator and the appropriate use of patient information.

93. While there is no doubt about the need for rigorous ethical approval, we do have evidence that the bureaucracy involved is seriously holding up clinical trials. Pharmaceutical companies testing new drugs are very keen, for commercial reasons, to make rapid progress in clinical trials. As we have discussed earlier (see para 75), we consider it desirable that the number of patients recruited into clinical trials should be increased. If the procedures for ethical approval are discouraging pharmaceutical companies from doing trials in this country then new procedures must be found which accelerate approval while retaining proper ethical scrutiny. The ABPI told us that the UK was "one of the slowest places in Europe to begin a clinical trial".[136] It suggested that one of the reasons for this was the recent creation of Multi-Centre Research Ethics Committees (MRECs) in each NHS Region, which, far from meeting their purpose of accelerating review and approval procedures, had in many cases resulted in delay. MRECs were intended to review the trial protocol but then approval was also required at a local level from an LREC, which would only consider the local site, staff and the use of patient information. The ABPI told us that the MREC system has, in reality, increased the minimum time necessary to obtain ethical approval, by a minimum of a month and on one occasion by as much as a year.[137] The CRC agrees with this assessment.[138] Part of the problem seems to be that the MRECs and the LRECs are managed by different and geographically separate NHS departments. Professor Sir Richard Peto of Oxford University told us that a recent study in Scotland "finished up having to send something like 5,700 separate pages of detailed text on the ethics of some study or other... just within the different centres in Scotland".[139]

94. Further approvals, such as a Clinical Trials Exemption Certificate (CTX) in the case of companies, are required from the Medicines Control Agency (MCA) before starting a clinical trial. The MCA must approve the trial drug for safety. The Local NHS Trust R&D committees, which check that the local finances are in place, can present another hurdle. The ABPI is content with the efficiency of the MCA's procedures but expressed concern about the lack of regulation for the local R&D committees which, it is argued, introduce further unnecessary delays.[140] As a result, the ABPI told us that "some companies who are doing multi-centre clinical trials are not putting clinical trials in the United Kingdom involving more than four centres in order to bypass some of the approval process".[141]

95. We recommend that the Government ensures that ethical, safety and financial approvals for clinical trials are administered more effectively so that trials can proceed as quickly as possible after the submission of protocols. We believe that for multi-centre trials ethical approval from one of the MRECs should be sufficient. The Government should benchmark its performance in this area against other European countries.

83 Q. 427. Back

84 Q. 312. Back

85 See, for example, QQ. 166, 296, 312 & 472. Back

86 See Annex 2. Back

87 QQ. 309 & 473. Back

88 See Ev. pp. 2 & 48; QQ. 240, 309 & 462. Back

89 See, for example, Ev. pp. 87, 156, 250 & 339; Q. 318. Back

90 Ev. p. 98; See also QQ. 51 & 78. Back

91 See Annex 1. Back

92 See Annex 1. Back

93 Q. 306. Back

94 Ev. p. 86. Back