August 22, 1990

Ethical Implications of Rejecting Patients for Clinical Trials

Author Affiliations

Columbia University School of Public Health New York, NY

Columbia University School of Public Health New York, NY

JAMA. 1990;264(8):973-974. doi:10.1001/jama.1990.03450080059028

To the Editor.—  The excellent editorial by Dr Chalmers1 neglects to mention a critically important group generally excluded from clinical trials: the population of fertile women. The Food and Drug Administration specifies their categorical exclusion because of the possibility of inadvertent exposure of an embryo to an experimental medication.2This stance relies on assumptions with which we disagree and has serious adverse consequences. The implicit underlying assumption is that an adult woman is not competent to participate in the informed decision-making process that leads to enrollment in a clinical trial, one in which she understands the risks and benefits for her own health and the theoretical risks to an embryo, and agrees to contracept for the duration of the clinical trial. The second assumption is that if she then experiences a contraceptive failure and conceives, she cannot responsibly and intelligently weigh the available information and decide whether to