Ethical and design issues of phase I clinical trials in cancer patients.

Therapeutic clinical trials are an absolute necessity to enhance the therapy of serious illnesses, and Phase I trials are the only way to introduce new therapeutic modalities into use in human beings. However, since the first obligation a physician has is to the individual patient's well-being and avoidance of doing harm, offering such patients an unproven therapy with low probability of benefit to him/herself and significant potential toxicities poses major ethical problems. These ethical problems can only be solved by full disclosure of all facts to the patient, a detailed explanation that the primary goal of the trial is to improve medical care (altruistic motivation), and by making sure that in addition to the trial mandated treatment the patient receives optimal palliative care, including hospice care when needed.