This is Part One of a two-part series focusing on the clinician’s role in clinical trials. Part Two will explore the ethics of recruiting patients for Phase 1 trials.
In July of 2007, trials for a gene-based intervention for arthritis were temporarily suspended following the death of Jolee Mohr, a participant. Although investigations by both the Food and Drug Administration and the company resulted in findings that the investigational treatment was not at fault and the trial has been restarted, some questions were raised about the nature of the informed consent and the role the patient’s community-based physician played in her recruitment.
At one time, clinical trials in the United States were almost entirely within the purview of the academic medical center (AMC). In 1991, 80% of industry money for clinical trials went to AMCs.1 By 2007, the community physician was getting nearly 77% of the spending for clinical investigations.2
In both instances, in the United States, the Institutional Review Board (IRB) takes the lead in approving the outlines of a protocol and making sure these meet the various legal, ethical, and regulatory requirements.
“The IRB serves as an arm of the Office for Human Research Protection [OHRP], of [the Department of Health and Human Services] and is charged with local oversight in institutions involved in human subject research,” says Elan Czeisler, director of the IRB for New York University Medical Center in New York City. “They are charged with both the review and oversight of research and ensure that they comport with safeguards enacted by legislation and regulations in place to protect research subjects.”
One major concern for physicians thinking about participating in a clinical trial is in the area of informed consent.
“According to federal statute, informed consent has to be an educational process and not just a form people sign,” says Eric Matteson, MD, chair of the division of rheumatology at the Mayo Clinic in Rochester, Minn. “Research subjects have to voluntarily decide to participate in research and it is important that they clearly understand everything about the trial, including the very substantial risk that is sometimes involved.”
The most meaningless question an investigator can ask is, ‘Do you understand?’ That isn’t really a question, but rather a statement designed to get a yes.
—Eric Matteson, MD
Informed Consent in Clinical Trials Different from Regular Practice
Informed consent in a clinical trial differs greatly from the informed consent obtained before surgery. One of the aspects least understood by both subject and investigator is the focus of the interventions.