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, or in trials for which survival is a major endpoint, a substantial risk of recurrence of the prior malignancy, as defined by the treating physician, may be an appropriate reason for exclusion. However, an individual who has undergone potentially curative therapy for a prior malignancy, who has had no evidence of that disease for five years, and who 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.

Individuals known to be HIV-positive should not be arbitrarily excluded from participation in clinical cancer treatment trials. 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 immune deficiencies, or if 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 known HIV-positive status for whom the probability of death due to underlying HIV-infection is high over the likely time course of the study. Patients with AIDS-defining cancers, such as non-Hodgkin’s lymphoma, Kaposi’s sarcoma, and cervical cancer, should be enrolled on disease-specific trials for HIV-positive individuals.

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.