Guidelines Regarding the Inclusion of Cancer Survivors and HIV-Positive Individuals on Clinical Trials

Individuals with a history of a prior malignancy may not be arbitrarily excluded from participation in clinical cancer treatment trials. Exclusion of individuals with a prior malignancy from a particular trial must be based on clear and compelling scientific grounds that show that exclusion is necessary for the conduct of the research, or that the individual does not meet essential eligibility requirements of the trial. For example, prior chemotherapy or radiation therapy may be an appropriate reason for exclusion if, for example, the prior treatment makes administration of protocol-defined therapy inadvisable. If overall survival is a major study endpoint, and there is substantial risk of recurrence of the prior malignancy, then the prior malignancy may be an appropriate reason for exclusion. However, an individual who has undergone potentially curative therapy for a prior malignancy and is deemed at low risk for recurrence by her/his treating physician, should be presumed to be eligible for a cancer treatment trial for a second malignancy. Patients receiving chronic therapy with expectations of long-term survival, for example, in some cases of breast or prostate cancer, should not be arbitrarily excluded from clinical trials.

Individuals known to be HIV-positive should not be arbitrarily excluded from participation in clinical cancer treatment trials. With effective antiretroviral therapy, individuals with undetectable HIV viral loads by standard clinical assays should generally be considered eligible for a study should they meet all the other eligibility criteria of the trial. Exclusion of HIV-positive individuals from a particular trial must be based on clear and compelling scientific grounds that show that exclusion is necessary for the conduct of the research, or that the individual does not meet essential eligibility requirements of the trial. Such grounds for exclusion may include laboratory, animal or clinical evidence suggesting that a treatment may be associated with increased adverse effects for individuals with well controlled HIV infection, or that HIV-associated symptoms may preclude accurate assessment of toxicity or response to the treatment. If survival is a primary endpoint, it may be appropriate to exclude patients with HIV-positive status who have AIDS-related complications and for whom the probability of death due to underlying HIV-disease is high over the likely time course of the study. Otherwise, HIV-infection should be considered as any other co-morbid condition that should be managed as per standards of care while a given patient is participating in clinical research.

Arbitrary exclusion of individuals with a prior malignancy or individuals known to be HIV-positive from extramural research potentially violates the Americans with Disabilities Act (ADA) and the Rehabilitation Act of 1973.