Clinical trials harmed by lack of informed consent

The mention of clinical trials often triggers a silence between physician and patient, usually because neither one knows much about the subject. Nearly 80% of physicians admit they would like to know more about clinical trials so they can help their patients make an informed decision before volunteering to participate.

"Most subjects enrolled in clinical studies have a meager understanding of what they have gotten into," says Alan Sugar, MD, chairman, New England Institutional Review Board and professor of medicine at Boston University School of Medicine. "Informed consent has largely focused around the signed form and has not practically become the continuous process that it needs to be. As a result, a subject’s misunderstandings largely go unchallenged."

Properly informing patients is not only ethically necessary, say clinical trials experts, but it also ensures better trials and data. Last year, more than 17 million people thought seriously about participating, but only a few million actually completed their trials. And even among them, many gave their consent without a thorough knowledge of the facts. Indeed, patients can be so daunted by questions and lack of information that they simply decide not to volunteer.

"There’s a simple ethical mandate that you don’t ordinarily do dangerous things to people without their knowledge and consent," says Dale E. Hammerschmidt, MD, FACP, associate professor of medicine and director of Education in Human Subjects’ Protection for the University of Minnesota Medical School in Minneapolis. "From a more pragmatic perspective, a well-informed subject is likely to cooperate better with the trial and is more likely to report potential problems. The quality of the data and the safety of the trial are both enhanced when the subjects really know what’s going on."

A new resource, written for doctors and clinical trial participants, can help answer some of these tough questions. Boston-based CenterWatch, the leading publisher of clinical trial news and information, now offers Informed Consent, a guide to the risks and benefits of volunteering for clinical trials.

Informed Consent is a step-by-step guide that begins with a history of the clinical trials industry, explores the drug development process, and how a new drug makes its way to the marketplace. It also details why people decide to participate, how to find clinical trials, how to research clinical trials and evaluate their risks, how to ensure proper informed consent, what the vulnerable populations are, and what to do when things go wrong. Cost is $16.95, and can be ordered from CenterWatch at (800) 765-9647, or by faxing (617) 856-5901. It also can be ordered through www.centerwatch.com, www.amazon.com, and www.barnesandnoble.com