Guide addresses questions on clinical trials

Patients need to know what their participation could mean for them, as well as for the researchers, before enrolling.

By Susan J. Landers, amednews staff. May 27, 2002.

Washington -- A new guide designed to answer patients' questions about the pros and cons of participating in clinical trials has been published as the number of clinical trials increases along with the concerns of the potential enrollees.

There are about 80,000 clinical trials being conducted in the nation, and finding enough volunteers to enroll in them consumes up to a quarter of a researcher's time, said Diana L. Anderson, PhD, president and CEO of a private clinical research company in Dallas.

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The awareness of clinical trials in the country is very low, said Dr. Anderson, who is also the vice chair of the 16,000-member Assn. of Clinical Research Professionals. "Somewhere around 4% of people who would be eligible to participate in a trial have ever been in a trial," she said. "And we've had a lot of negative press lately."

While the death of a participant in a gene therapy trial at the University of Pennsylvania, Philadelphia, was a great tragedy, Dr. Anderson noted that there are many more instances in which trials go very well.

A recent Harris Interactive survey revealed why researchers face a tough recruitment job. The vast majority of those queried said they were nervous about participating in clinical trials, and many expressed some doubt that they would receive very good medical care if they volunteered. Only about 25% of the 2,031 adults surveyed online last February said they were confident that new treatments are tested on human subjects only after there is valid scientific evidence that the treatments are likely to be effective and safe.

On the other hand, Harris respondents overwhelmingly endorsed the need for clinical trials. More than 80% of those questioned said it was either "essential" or "very important" that "all new prescription drugs or other new treatments should be tested on human beings in clinical trials before they are approved for general use."

80,000 clinical trials are being conducted in the U.S.

The new guide is intended to address this mismatch of fear and priorities. "We recognize that there has been little information to support patients and families confronting the question, 'Should I enter a clinical trial?' " said American Assn. of Health Plans President Karen Ignani.

AAHP commissioned the guide, "Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness." The guide was written by ECRI, the nonprofit health services research organization formerly known as the Emergency Care Research Institute, and funded by a grant from Pfizer Inc.

The publication won the praise of Marjorie Speers, PhD, executive director of the Assn. for the Accreditation of Human Research Protection Programs. "Any individual who wants to learn more about clinical trials research or is considering participating in a clinical trial should read this publication," she said.

"Creating an informed public, particularly among patients, about clinical research is critical to conducting research ethically," she said. "Knowing what types of questions to ask their physicians and investigators will help to ensure that research subjects are truly informed and give their voluntary consent to participate."

Among the issues covered in the guide:

The experimental nature of a clinical trial.
How to find trials that are recruiting patients.
Explanations of the four general phases of trials.
The meaning and importance of the informed consent process.
Risks to the participants.

The guide also recommends that patients ask their physician or the researchers about potential conflicts of interest. Questions such as the researchers' reasons for doing the trial and their relationship with the company whose products are being tested in the trial are fair game.

Potential participants also should discuss costs associated with the trial and who will pay those costs. Patients will need to check with their insurers about possible coverage. More information is available from an ECRI document, Should I Enter a Clinical Trial? (http://www.ecri.org/documents/bctoc2.html).