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Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness

This Guide provides checklists that may be useful during your discussions with physicians and loved ones about whether to enter a clinical trial. Resources for patients considering participating in clinical trials include:

The full Guide and Summary take no position on whether one should enter a trial—that is a uniquely personal decision. Our hope is that patients consult the full Guide to support their decision making about enrolling in a trial so they can feel as confident as possible about their decision. We dedicate this Guide to the patients and their loved ones who are facing this important decision and to those who benefit us all by participating in a trial.

Patient Reference Guide Technical Report
Patients' reasons for participation in clinical trials and effect of trial participation on patient outcomes is the technical report (also called a health technology assessment report or evidence report) that underpins the analysis and findings presented in two chapters of this guide: Chapter 8 "Do patients treated in clinical trials have better outcomes than similar patients treated outside clinical trials?" and Chapter 13 "What reasons do patients give for participating or not participating in clinical trials?"

To answer these questions, ECRI Institute performed a comprehensive search for published studies that address these issues. A research analyst then reviewed and analyzed the data contained in the published studies we identified and wrote this technical report. The findings from this technical report were adapted for inclusion in Chapters 8 and 13 of the Guide.

Policy Statement
Institute is solely responsible for the content of this Patient Reference Guide. The information in this Guide—including the conclusions—should be interpreted judiciously. This information is provided with the understanding that ECRI Institute is not rendering any medical or legal advice or decisions on healthcare coverage or the provision of care to individual patients.

This Patient Reference Guide includes a summary of ECRI Institute's technical report that evaluated the available research evidence about (1) why patients enter clinical trials and (2) how well patients who receive medical care in a clinical trial do compared to patients treated for the same health condition outside a clinical trial.

The information in this Guide is based on the available published scientific and medical literature as of June 2001. Scientific and medical knowledge evolves and may change over time as new research is published. You are urged to discuss the material in this Guide and the issues it raises with your medical doctors. This Guide does not include a complete description of the analytical methods ECRI Institute uses to reach its conclusions on a particular topic. Those methods are fully described in ECRI Institute's technical report.

The Guide is also available online at Additional hard copies are available in limited quantity through the American Association of Health Plans (AAHP).

Note: This Patient Reference Guide was funded by an unrestricted educational grant from Pfizer, Inc. to the American Association of Health Plans.

Learn More
For more information about this resource, feel free to call us at 610-825-6000 or e-mail us at