April 2002 -- ECRI and the American Association of Health Plans (AAHP) today announced publication of ``Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness.'' The new guide (available electronically at no cost at http://www.ecri.org and http://www.aahp.org ) is the first comprehensive reference designed for patients and their physicians to use to answer patient questions about the risks, benefits, and implications of entering a clinical trial. It provides a detailed road map for patients to navigate the decision-making process.

According to a new edition of the Harris Poll®, most Americans believe that clinical trials contribute significantly to medical knowledge. The poll also suggested that there is a need for better information for patients.

``Should I Enter a Clinical Trial?'' was envisioned with that goal in mind. It was produced with guidance from advisory and review committees, two panels that included representatives of patient advocacy groups, patients and their families, researchers and federal agencies conducting research, and practicing physicians.

Among the key issues covered in the full reference and companion summary guides are:

• What is a clinical trial?
• What are the different types of trials, and why should patients take the time to understand those differences before making a decision?
• Where can patients find out about clinical trials that are recruiting patients?
• How can patients find out if they are eligible for a trial?
• Who should a patient talk to about a trial before deciding to enroll?
• How might different trials affect patients' quality of life?
• Who shares responsibility for protecting patients in clinical trials?
• How can patients make sure they receive adequate information about the risks of a trial when deciding whether to enroll?
• Can patients receive a treatment under investigation even if they are not eligible for the trial?
• What potential conflicts of interest exist among trial sponsors, researchers, and institutions carrying out the trial?

``Sorting through complex issues and presenting reliable information in a form that is easy for patients to understand is critical,'' said Jeffrey C. Lerner, Ph.D., president and CEO of ECRI. ``Developing evidence-based information for patients is at the core of ECRI's mission,'' Lerner emphasized.

``Should I Enter a Clinical Trial?'' is the latest addition to ECRI's online consumer and patient information library. The library currently includes a guide on the use of high-dose chemotherapy to treat metastatic breast cancer and a Web site devoted to technologies used to diagnose and treat diabetes.

``We recognized that there has been little information to support patients and families confronting the question 'Should I enter a clinical trial?''' said AAHP President Karen Ignagni. ``Partnering with ECRI allows AAHP to provide a resource that we hope will be valuable to patients and their doctors,'' she said.

The guide was funded through an unrestricted educational grant from Pfizer, Inc., to AAHP. The patient reference guide is a complement to AAHP's ``Health Plan Guide to Clinical Trials'' published in June 2001.

The guide also addresses ethical issues that have emerged in clinical research and the potential implications of these issues for patients in trials. It includes a glossary, resources for locating clinical trials currently seeking to enroll patients, and checklists to work through during the decision-making process. In addition, the guide includes information on regulations, laws, and principles that govern trials.

The patient reference guide has been made available to physician groups, consumer groups, and health plans and is being well received throughout these communities. To contact a bioethicist, clinical researcher, patient, Institutional Review Board member, or patient advocate now using the guide, contact Diane Robertson at 610-825-6000, ext. 5381, or Karen Sherwood at 202-778-8471.

ECRI (formerly the Emergency Care Research Institute) is an independent, nonprofit health services research organization dedicated to improving the safety, efficacy, and cost-effectiveness of health technology. ECRI is a Collaborating Center of the World Health Organization and is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. As such, ECRI provides authoritative guidance and decision support in a variety of healthcare arenas and is often referred to as the ``Consumer Reports for medical devices.''

The American Association of Health Plans (AAHP) is the largest national trade organization representing more than 1,000 health maintenance organizations (HMOs), preferred provider organizations (PPOs), and other similar health plans that provide health care coverage to more than 170 million Americans.

SOURCE: ECRI; American Association of Health Plans