Patient Guide Helps Demystify Clinical Trials
Mon Apr 8, 1:16 PM ET
By Karen Pallarito

NEW YORK (Reuters Health) - The serious injury and even death of patients participating in clinical trials at several renowned US medical institutions has shaken public trust, leading to a broad re-examination of efforts to ensure patient safety and inform potential candidates of the risks of such experimental care.


Now a new reference guide has been developed to demystify the process. Written specifically for patients facing a serious or life-threatening illness, as well as their physicians and family members, the 113-page guidebook lays out the inherent risks, benefits and implications of participating in a clinical trial.

"We recognized that there has been little information to support patients and their families confronting the question, 'Should I enter a clinical trial,"' said Karen Ignagni, president of the American Association of Health Plans. AAHP commissioned ERCI, an independent nonprofit research organization, to produce the guide.

"Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness," was funded through an unrestricted educational grant to AAHP from Pfizer Inc.

A voluntary advisory panel consisting of patient advocates, physicians and researchers helped ECRI in preparing the guide. A separate, similarly comprised panel reviewed drafts of the report.

The guide is based on the latest published scientific and medical literature through June 2001. It is organized in sections that cover key issues, including discussions of the types of clinical trials, patient recruitment and eligibility, informed consent, coverage of costs incurred in a trial and ethical issues.

Patients will learn how to enter a clinical trial and what kind of care to expect during the trial.

The guide provides checklists of information patients need to know and questions they'll need to ask. A glossary in the back defines relevant terms in plain language. It also includes a list of organizations and Web sites for identifying ongoing clinical trials.

The guide refrains from taking a position on whether people should enter a trial. "That is a uniquely personal decision," it says.

However, it does deal head-on with sensitive consent issues, even acknowledging the untimely death of 17-year-old Jesse Gelsinger in a gene therapy trial. Gelsinger's highly publicized death marked a turning point in the nation's resolve to bolster patient protections.

It also makes it clear that the main purpose of a clinical trial is to advance medical knowledge for future patients. Individual patients may or may not benefit from a treatment.

Copies of the full guide or a companion summary are available online at www.ecri.org or www.aahp.org.