Enrolling Ineligible Patients in Trials

I was not aware that physicians violate clinical trial enrollment criteria by allowing unsuitable patients to participate in trials.

In the 10/29/09 New York Times, Pauline Chen, MD writes about her ethical concerns that arose from wanting to enroll a very sick patient in a clinical trial. Dr. Chen explains that her patient, who was diagnosed with liver cancer and only had 3 months to live, just wanted to live long enough to see her first grandchild be born. Dr. Chen begins to think about enrolling the patient in a clinical trial for an experimental drug.

The article goes on to explain that many physicians are faced with this ethical decision: to maintain study enrollment criteria and protocol and therefore obtain information that can be generalized for all patients or to violate study rules by focusing on improving the health of one patient. If physicians do allow patients to be enrolled in clinical trials by not disclosing how sick the patient really is, not only are patients harmed, but the trials can be as well. In a survey of 700 physicians published in an bioethics journal, 90% responded that they are alright with violating trial enrollment criteria if a patient could benefit from the trial. Also surprising is that more than 60% of physicians said that they would break study rules to help a patient.

Findings indicate that the value of the relationship between the patient and physician is still high; physicians are willing to violate medical ethics to retain the patient-physician bond and help patients live longer, even if they may ultimately die from an uncured illness. Dr. Chen's patient was provided with the study drug without enrolling in the trial and she lived long enough to become a grandmother, dying a few days later.

This article and study further call into question clinical study results and medical ethics. Link to article: http://www.nytimes.com/2009/10/29/health/29chen.html