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


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


This guide is for adults with a serious or life-threatening illness who may seek treatment in a clinical trial. It is also for their loved ones and the health care professionals who support them during their decisionmaking process and treatment.

This guide offers carefully researched, objective information about the world of clinical research today–the study of new (also called experimental or investigational) treatments in humans. The guide explains how and why clinical research is conducted. It answers questions about many of the issues that affect patient participation. It discusses the roles and responsibilities of Federal agencies such as the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and Office for Human Research Protections in protecting patients.

Questions addressed in the guide include:

  • Who should use this guide?
  • How do we know what works in medicine?
  • What is a clinical trial?
  • What are the differences in the phases of trials?
  • What is randomization in a controlled trial?
  • How do I find out about available clinical trials?
  • How do I enter a clinical trial?
  • Do patients treated in clinical trials have better outcomes than similar patients treated outside clinical trials?
  • What kind of care can I expect during a clinical trial?
  • What is “informed” consent?
  • Is there patient confidentiality in a clinical trial?
  • What is an institutional review board?
  • What reasons do patients give for participating and not participating in clinical trials?
  • Will the kind of health care facility conducting the trial affect my care?
  • What if I need other medical care while I’m in a trial?
  • What costs will I incur in a clinical trial? Will my health insurer pay?
  • Are patients ever paid for being in a trial?
  • What are the ethical issues in clinical research?



Funding Sources:

American Association of Health Plans


Release Date: 2002
Original Summary: October 2003
Last Updated: 05/19/08

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