False Data and Last Hopes: Enrolling Ineligible Patients in Clinical Trials

Despite the 1966 US Public Health Service's Directive on Human Experimentation, many unresolved issues remain surrounding the use of human Ss in research & potential conflicts between the principles of scientific methodology & those of patients' best interests. The emotional & social context of cancer research make it extremely tempting for MDs to lie or manipulate data on some patients regarding their eligibility to enter into clinical trials of investigational drugs. The issue of whether such deception is justified for the sake of possibly prolonging a patient's life is explored. It is concluded that allowing ineligible candidates into such research may render the results misleading or meaningless. Some suggestions are provided to relieve researchers' ethical tensions regarding these patients, eg, providing treatment outside the clinical research setting. Modified HA