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Palliative care and cancer trials
  1. S M Brown1,
  2. K Sikora2,
  3. A Levin3
  1. 1Section of Palliative Care, Department of Oncology, King Faisal Specialist Hospital and Research Centre, Riyadh, MBC 64, Department of Oncology, PO Box 3354, Riyadh 11211, Kingdom of Saudi Arabia;
  2. 2Department of Cancer Medicine, Imperial College, Hammersmith Hospital, London W12 0NN, UK and Global Clinical Development AstraZeneca, Macclesfield SK10 4TG, UK
  3. 3East Africa Research Project, Department of Virology, St Bartholomew’s and the Royal London School of Medicine and Dentistry, 38 Little Britain Street, London EC1A 7BE, UK

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    Two of the most important concepts in medicine are “curing” and “caring”. Patients should enter clinical trials with the understanding that they benefit from the treatment or that there may be some benefit to others. In many cancer trials, for example, the best that can be hoped for is a prolongation of life. Whether or not life is prolonged, we argue that there exists an obligation which can be termed a “bond of responsibility” to provide appropriate palliative care within the patient’s own cultural context.

    The Declaration of Helsinki,1 the principal code governing the conduct of medical research, shows this “bond of responsibility” to be at its core. A number of statements stand out: “the health of my patient will be my first consideration”2 and “a physician shall only act in a patient’s best interest when providing medical care which might have the effect of weakening the physical and mental health of the patient”.3 Article 10 reads: “It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject”. These three statements formulate in broad but very strong terms the intrinsic duty of medical researchers to act in much more than a neutral or disengaged manner. They cannot be concerned only with limiting harm from the trial itself; they imply a role of beneficence rather than mere non-maleficence.

    Finally, article 30 in the Declaration of Helsinki states that “at the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study”. Although this refers specifically to benefits from the study in question, we feel there is undoubtedly a strong ethic of commitment to non-abandonment of the patient, which essentially represents the action of beneficence over a longer period. It does not, however, deal in specific terms with participants who may eventually become terminally ill. How then can researchers maintain this “bond of responsibility” when they investigate patients with life limiting diseases?

    The last 40 years have seen the worldwide development of the discipline of palliative care with the ethos of non-abandonment at its core. Patients with cancer are known to suffer considerably, with many studies pointing to measurable burdens of pain and other symptoms.4 For instance, around 60% of patients with advanced cancer have severe pain requiring opioids and 25% have dyspnoea. Palliative care has been shown in many settings to be very effective in minimising the suffering not only from late stage cancer but also from other terminal diseases.

    Most clinical trial protocols address the problem of patient follow up in the context of collecting data for statistical analysis. Loss to follow up is an accepted aspect of protocol design. It is possible that advancing disease prevents many subjects from attending follow up appointments. Patient follow up is therefore an ethical issue as well as a research problem.

    We suggest there is a strong link, a “bond of responsibility”, between researcher and participants in clinical trials, especially in the situation where the participant faces a potentially terminal illness. We feel there should be consideration of an amendment to the Declaration of Helsinki that would address the question of care for patients with potentially life limiting diseases who are recruited into clinical trials.

    Where the option of appropriate palliative care is not already available, the researchers and their funding agencies should ensure that such a service is provided (and incorporated into the budget) before recruiting patients. This is particularly important in emerging countries where for many patients palliative care is the only treatment option for their more advanced cancers. We are aware that the provision of palliative care, especially in these developing countries, can be difficult.5 There have, however, been many successes in the past as well as recent initiatives.6,7 We are also aware that there is the potential problem of researchers undertaking an open ended commitment for supporting patients and providing services that could be prohibitively expensive. What we advocate is that practicable provision of palliative care be a component for those clinical trials where the participants are likely to enter the terminal stage of their disease. The people who are subjects of such trials would not be abandoned and the benefits of medical intervention would persist.8,9 Then the “bond of responsibility” that binds researcher and patient will be preserved.


    We wish to thank Chris Palmer, Alan Gray, Alison Brown, and Nellie van Bruggen for their comments and assistance with this letter.