Academic journal article The Hastings Center Report

Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research

Academic journal article The Hastings Center Report

Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research

Article excerpt

In recent years, a number of events have raised concerns about the adequacy of safeguards to protect people who volunteer for medical research. Individuals without a serious illness, like Jesse Gelsinger and Ellen Roche, have died unexpectedly while participating in clinical trials. (1) The federal Office for Human Research Protections temporarily halted studies at several major academic centers for their failure to observe research guidelines. (2) Overseas trials of HIV-therapy during pregnancy have been criticized for including a placebo control arm. (3) For some studies, we must worry whether research subjects are placed at too great a risk by physicians seeking to advance medical knowledge.

At the same time, we must also question whether research safeguards are sometimes overly protective of people who might enter clinical trials. Progress in treating trauma patients, for example, was hampered for many years by the requirements of informed consent--seriously injured patients often lack the decision-making capacity necessary to agree to enrollment in a research trial, and family members may not be available to consent to the trial on their behalf. These difficulties in enrolling patients slowed the development of promising therapies--including more effective methods for cardiac resuscitation and substitutes for blood to transfuse patients who have suffered major blood loss. (4) To address this problem, federal guidelines for informed consent were modified in 1996 to permit valuable research in the emergency setting. (5)

This article argues that just as there was a need to relax the requirements of informed consent for trauma research, there is a need to relax the precautions taken to ensure voluntary participation of subjects in another kind of research trial--studies involving the comparison of two or more established therapies to see whether one is superior to the alternative(s). For many medical problems, physicians can choose among multiple therapeutic options, and the choice is typically based more on hunch than on data. Patients would benefit greatly from studies that clarify the relative benefits and risks of different options for their illnesses.

However, these studies can be delayed--and medical progress impeded--by difficulties in securing the participation of enough individuals. (6) In the AFFIRM study comparing the two leading therapies for chronic atrial fibrillation, for example, only fifty-five percent of patients invited to enroll in the study chose to do so. (7) In a study of alternative therapies for some chronic lung diseases (including asthma and emphysema), more than half of the patients invited to participate in the study declined the invitation, with total recruitment taking twice as long as expected (sixteen months instead of eight months). (8)

Patients decline invitations to enroll for a number of reasons. Some people are uncomfortable with the idea of being part of a testing process, or with the possibility that which treatment they will receive will be decided randomly. (9) Many of these patients are concerned that the physicians are more interested in the research study than in the patient's care. (10) Patients also cite concerns about the burden of extra tests and appointments and the uncertainty of the consequences for their health from participation. (11)

Researchers and trial sponsors have employed a number of approaches to address the difficulties in recruiting patients for clinical trials. Some have employed more intensive recruitment practices, including notices on radio and television. (12) Others have taken their trials overseas, where recruitment is often easier. (13) But these alternatives are either insufficiently effective (14) or raise their own ethical concerns. (15)

This article argues on behalf of another way to increase patient enrollment in clinical trials: It should be permissible for a physician to condition a patient's access to treatment on the patient's willingness to enter a clinical trial when the trial compares two or more accepted therapies to find out whether they are equivalent or whether one is better than the others. …

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