Patient guide helps demystify clinical trials

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Patient guide helps demystify clinical trials

By Pallarito

NEW YORK, Apr 08 (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 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 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.