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August 22, 1990

Ethical Implications of Rejecting Patients for Clinical Trials

Author Affiliations

Henry Ford Hospital Detroit, Mich

Henry Ford Hospital Detroit, Mich

JAMA. 1990;264(8):973. doi:10.1001/jama.1990.03450080059027

To the Editor.—  I take strong exception to certain editorial comments of Dr Chalmers1 on the ethics of exclusion of patients from clinical trials. He seems to misunderstand the fundamental purpose of the clinical trial, which is to evaluate therapy, not to provide it to all and sundry. No patient has a right to be included in a clinical trial. The investigator's principal obligation is to answer the questions at hand; otherwise, no trial should be conducted. The inclusion of subjects who cannot properly be evaluated because of confounding variables may obscure important results and require an excessive number of subjects to be exposed to a treatment to overcome the "noise." The exposure of the subjects to a potentially harmful treatment thus may be "wasted." This is a real ethical error. If the trial is necessary in the first place, it is essential that it be conducted in the