Select Committee on Health Minutes of Evidence

Memorandum by Cancer Research UK (PI 59)


  1.1  Cancer Research UK[3] is the world's largest independent cancer research organisation, with an annual research spend of over £213 million. Cancer Research UK funds research into all aspects of cancer from exploratory biology to clinical trials of novel and existing drugs as well as population-based studies and prevention research.

  1.2  Cancer Research UK recognises the high level of capability and expertise within the pharmaceutical industry, particularly in taking novel diagnostics and drugs to market. Cancer Research UK works with the pharmaceutical industry where such collaborations help us achieve our aims.

  1.3  Cancer Research Technology Ltd is the technology transfer arm of Cancer Research UK and is responsible for most direct interactions with industry. Cancer Research Technology's principal function is to facilitate the development of cancer discoveries which could form the basis of new diagnostics, therapeutics, or enabling technologies. Cancer Research Technology handles all licensing and contractual relationships with pharmaceutical companies arising from research funded by Cancer Research UK. All drugs, diagnostics or research tools licensed to pharmaceutical companies by Cancer Research Technology are issued on the condition that the eventual marketed product is aimed at maximising patient benefit.

  1.4  Cancer Research UK is Europe's major non-commercial funder of research into drug innovation. We support this research through project-based and long term funding. The latter provision underpins our funding of specific clinical trials by supporting areas such as exploratory biology and the development of predictive biomarkers for drug efficacy and toxicity.

  1.5  Cancer Research UK supports drug innovation work through two main mechanisms.

  1.5.1  Firstly, our in-house Drug Development Office takes new drugs first into man[4]. The Drug Development Office and key Cancer Research UK clinical centres have taken over 100 drugs into man for the first time. Cancer Research UK has traditionally only taken these drugs to a phase in development where they can be licensed out to the pharmaceutical industry. Because of the cost and regulatory requirements we do not conduct clinical trials aimed at gaining marketing authorisation.

  1.5.2  Cancer Research UK has stringent procedures to ensure the quality and clinical relevance of our early drug development. Around 30-50% of the drugs that our Drug Development Office takes into man for the first time are provided by biotechnology companies. All proposals to take these drugs into clinical trials are required to have detailed protocols, developed by the investigators in collaboration with our Drug Development Office. These protocols are then subject to international expert peer review and internal review by Cancer Research UK's New Agents Committee. All trials conducted in the UK are required to be scrutinised by independent Research Ethics Committees. Cancer Research UK requires that all results from trials are published. If the drug being tested has been provided by industry then they will bear the full development cost. In these instances Cancer Research Technology and Cancer Research UK's Drug Development Office will ensure that appropriate intellectual property rights are negotiated for the charity. In return the company will benefit by having access to considerable intellectual expertise across a wide range of disciplines (eg clinical imaging) during the development process and the clinical trials will be conducted in Cancer Research UK centres.

  1.5.3  Our second mechanism for supporting innovative drug research focuses on existing licensed drugs being applied in novel ways, or on different types of cancer from the one in which the drug was originally licensed. To support this, Cancer Research UK and the Medical Research Council have created the Clinical Trials Awards and Advisory Committee to peer-review and fund trials that are then run through the National Cancer Research Network. This body only considers trials for which the primary aim is benefit to patients. All results from these trials are scrutinised by an Independent Data Monitoring Committee, who are the only body to see unblinded data. All results emerging from trials approved by the Clinical Trials Awards and Advisory Committee are published.

  1.5.4  Pharmaceutical companies may support the above trials in a number of different ways, from providing free drugs, to fully funding some clinical trials. The key issue for Cancer Research UK, irrespective of whether clinical trials do or do not have any industry support, is that trials are all judged by the same transparent mechanism including extensive international peer-review, to judge the quality of the science and public benefit of the proposed trial. Importantly, Cancer Research UK retains control over the trial and the protocol as well as the data generated to which there is unrestricted access for analysis.


  2.1  Pharmaceutical companies play a key role in bringing innovative cancer drugs and diagnostics to market. However, advances in oncology should not only be considered in the context of individual drugs, but also the use of these drugs in combination with other drugs, surgical techniques or radiotherapy. We appreciate that for commercial or legal reasons it is often difficult for the pharmaceutical industry to make drugs available for clinical trials evaluating combinations of novel treatments. Nevertheless, it is essential that the UK finds a way to overcome this barrier for the best patient outcomes from both commercially and publicly-funded research. The academic sector has a critical role to play in evaluating novel treatment combinations, but may require funding support from Government or the pharmaceutical industry in order to do so.

  2.2  The pharmaceutical industry has the capacity to make a huge difference in drug innovation by further investment in novel approaches to early drug development. This could be achieved by greater partnership with not-for-profit research organisations. The future success of the pharmaceutical industry depends on taking new discoveries to the clinic, and we believe a more flexible partnership with the academic community would further enable such innovation[5]. Failure rates in taking cancer drugs to market are high (around 95%), due mainly to difficulties in demonstrating efficacy or for safety reasons. This clearly demonstrates the need for better experimental models, and for proof-of-principle trials to be performed earlier in the development process to prove that the drug will work according to expectation. These are both areas in which academia has particular expertise.

  2.3  As failure rates in drug development are so high, and the costs of development so enormous, Government needs to be careful not to further constrain useful drug development with an increasingly stringent and rigid regulatory regime. An example of such constraint is the requirement for primate research for certain types of pre-clinical assessment. If the costs and barriers for drug development continue to increase, fewer new drugs will comes to market, thus stifling innovation and, more importantly, potential patient benefit.

  2.4  The increasingly high costs of drug development also mean that pharmaceutical companies are less willing to take risks in developing drugs. This is particularly the case when developing drugs for small patient populations, such as some cancers.

  2.5  We welcome the European Commission call that support is needed for further research on rare and orphan disease[6] areas, given their current neglect by the pharmaceutical industry[7]. The majority of clinical research in this area is funded by the non-commercial sector. Cancer Research UK, for example, funds clinical trials conducted by the United Kingdom Children's Cancer Study Group. There is little incentive for industry to conduct research aimed at small patient populations.

  2.6  It is important that studies are carried out which identify which subgroups will benefit from particular therapies. There is currently a lack of pharmaceutical industry funding for these studies, which will, in effect, reduce market size for their products. However in the long term such studies can reduce the drug costs for the NHS by only treating those that will benefit. It is the responsibility of Government, possibly through the academic sector, to ensure that such studies are carried out, and the cost of the resulting diagnostic approaches is met.


  3.1  Cancer Research UK undertakes certain projects in collaboration with pharmaceutical companies. However, there are many areas of our work in which pharmaceutical companies do not have a strategic interest. Examples of these include the development of drugs aimed at cancer in children and orphan conditions, or radiotherapy and preventative research.

  3.2  Currently there is no obligation on pharmaceutical companies to publish the results of all trials. Whilst studies have shown that pharmaceutical support does not affect publication of late phase clinical trials[8], studies comparing all clinical trials have indicated overall that pharmaceutically sponsored trials are less likely to be published[9],[10]. This is of concern as a failure to publish can lead to overestimation of treatment effects, which has the potential to lead to inappropriate treatment decisions. We welcome recent decisions from some pharmaceutical companies (most recently Eli Lilly and GlaxoSmithKline) to publish all research results on the web, and would encourage other companies to follow suit. Ideally these results would be best placed on a comprehensive database for registration of all trials and their results.

  3.3  It is important that the pharmaceutical industry is not only focused on specific endpoints in medical trials, but investigates the wider effects of drugs. This information would not only be useful in the drug development process, but also to the wider clinical community when the drug comes to be used in practice or in future research.

  3.4  Increasingly research and development conducted on behalf of the pharmaceutical industry is relocating away from the UK to countries presenting larger markets for pharmaceutical products. As long as the UK National Health Service lags behind in adopting new treatments, the pharmaceutical industry will increasingly look elsewhere for future research and development investment. Research and development conducted for the pharmaceutical industry underpins non-commercial medical research in the UK, and the loss of such research activity would present a risk to UK medical research capability as a whole.


  4.1  The provision of accurate information to patients, through our CancerHelp UK website and a team of information nurses, is integral to Cancer Research UK's mission. On occasion, Cancer Research UK does attend briefings on specific drugs by pharmaceutical companies. However before any information is passed on to patients, we take independent advice, and we will not promote the prescribing of any one drug.

  4.2  Cancer Research UK supports the current regulations prohibiting direct-to-consumer advertising, and does not believe that they should be relaxed.[11]

  4.3  The increased emphasis on the development of lobbying groups by pharmaceutical companies to raise interest in the adoption of drugs or techniques is of concern. This can result in groups or individuals pushing for action in a particular area, without adequate consideration of the relevant evidence base.

  4.4  The funding of researchers by pharmaceutical companies to publish papers in journals to promote particular drugs in the absence of any new data should be discouraged.


  5.1  Cancer Research UK provides information on cancer prevention to General Practitioners and other health care professionals.

  5.2  Clinicians and researchers are offered a great deal of unsolicited information and invitations from pharmaceutical companies. It is therefore important, in the interests of transparency, that there is a greater emphasis on declaration of interests for all those involved in research, both in the not-for-profit and pharmaceutical industries.

  5.3  The European Medicines Agency reports that patients are now actively looking for information on diseases and medicines, and therefore providers of information should take account of this trend.[12] There is a need for clear, objective information for patients. Whilst pharmaceutical companies offer information to patients on treatments, this information will usually be linked to one particular drug or service and may therefore not provide a full picture of all the treatment options available. In this context the work of NHS Information Partners service is welcomed.


  6.1  Cancer Research UK is not actively involved in the regulatory review of drug safety and efficacy.


  7.1  Cancer Research UK responds to consultations from NICE on the basis of the knowledge of experts in the field and feeds their comments on draft guidance back to NICE on their behalf.

  7.2  Pharmaceutical companies have an important role to play in providing information on drugs as they undergo the process by which drugs achieve approval by the National Institute of Clinical Excellence (NICE). During the appraisal of a given drug, Cancer Research UK will therefore on occasion attend briefings by manufacturers, as well as seeking independent advice.

  7.3  The World Health Organisation (WHO) review of the NICE Technology Appraisal Process referred specifically to the influence the pharmaceutical companies have in this process. The WHO recommended that NICE address the inconsistency that commercial-in-confidence data will be accepted from pharmaceutical companies, whereas data that are unpublished or in abstract form will not be accepted from other sources.

  7.4  In addition, the WHO recommended that NICE should reduce duplication of effort in the assessment phase of technology appraisal development as both manufacturers and the appointed appraisal team produce separate reports to the NICE Appraisal Committee for evaluation. The WHO recommended that the appraisal team produce a single set of analyses incorporating consultation with and input from the manufacturer. All analyses carried out by the pharmaceutical industry should be subject to careful scrutiny.

  7.5  There is also some concern over the influence that manufacturers have on the topics considered by NICE for appraisal. Cancer Research UK has asked that more transparent processes be put in place to define the process by which drugs are referred for appraisal or not. We have also asked that a rationale be provided for the process of prioritisation of drugs for appraisal by NICE.

3   Registered charity no 1089464. Back

4   Newell DR, Searle KM, Westwood NB, Burtles SS. Professor Tom Connors and the development of novel cancer therapies by the phase I/II clinical trials committee of Cancer Research UK. British Journal of Cancer. 2003;89:437-54. Back

5   Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery, 2004;3:711-15. Back

6   An orphan disease is a disease for which no treatment has been developed because of its rarity. Back

7   Commission of the European Communities. A stronger European-based pharmaceutical industry for the benefit of the patient-a call to action. 2003;35. Back

8   Krzyanowska MK, Pintilie M, Tannock Ian F Factors associated with failure to publish large randomised trials presented at an oncology meeting. Journal of the American Medical Association. 2003;290:495-501. Back

9   Dickersin K, Chan S, Chalmers TC, Sacks HS, Smith H Jr. Publication bias and clinical trials. Control Clinical Trials. 1987; 8:343-353. Back

10   Easterbrook PJ, Berlin JA, Gopalan R, Matthew DR. Publication bias in clinical research. Lancet. 1991;337:867-872. Back

11   Sullivan R. Direct-to-consumer advertising: the future in Europe. Journal of the Royal Society of Medicine. 2000:93;400-401. Back

12   The European Agency for the Evaluation of Medicinal Products. Discussion paper, the European Medicines Agency Road Map to 2010: Preparing the Ground for the future. 2004;21. Back

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Prepared 26 April 2005