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Should I Enter a Clinical Trial?

ECRI Institute

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Should I Enter a Clinical Trial?

A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness

Who Should Use This Summary?

This Patient Reference Guide Summary highlights key issues covered in the full Guide, Should I Enter a Clinical Trial?, for adult patients who are thinking about enrolling in a clinical trial and their loved ones. Words that appear in bold are defined in the Glossary at the end. We provide checklists that may be useful during your discussions with physicians and loved ones about whether to enter a trial. A list of web resources shows where you can find information about clinical trials that are open for enrollment and more information about various issues related to clinical trials. The full Guide and Summary take no position on whether one should enter a trial — that is uniquely a persona 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.

You can access the full Guide on the web at www.ecri.org or www.aahp.org. If you cannot access it online or here, please contact the American Association of Health Plans (AAHP) to request a hard copy. We encourage readers to obtain the full-length Patient Reference Guide, which provides more detailed information about participation in clinical trials.


The knowledge gained through clinical research — trials that test the use of new drugs and medical devices in humans — is at the core of advances in patient care. The results of clinical trials bring us new diagnostic tests and new treatments that improve our health and prolong our lives. The amount of research being done has increased dramatically the past 10 years as researchers in the public and private sectors strive to develop and bring to the public more new diagnostic tests and treatments than ever. Thus, more patients than ever are needed to participate in trials.

In the press and on television, some institutions conducting clinical trials have come under public fire recently because of some serious adverse events and, rarely, unexpected deaths during trials. Although these situations represent a very small fraction of the current clinical research, they have shaken public trust. Patient safety and adequate explanations to patients about benefits and risks of trials have been key issues. At the heart of clinical research are individuals who, by volunteering to participate in a trial, benefit future patient care by helping researchers learn what works in medicine. Researchers cannot promise patients an immediate personal health benefit from participating in a trial, but patients have described to us other kinds of immediate benefits from trial participation.

As one cancer trial patient summed it up, “Tremendous support and benefit come from being a part of a group of patients who are just like you. You feel tremendous medical team support because the researchers are worried about your specific disease and are devoted to treating your disease. They know more than anyone else about it.” Another patient noted that even though she might not experience an immediate health benefit from the trial, she felt great satisfaction that her children or grandchildren might benefit from the knowledge gained from the trial.

This Summary offers some basic information to consider when deciding to enroll in a clinical trial. Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness provides more detailed information on these topics and other questions important to patients and their families. But the final decision about enrolling in a clinical trial rests with you and your loved ones. Being informed will enable you to make a decision that is right for you.

Among the key issues covered in the full guide are the following:

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

What Is a Clinical Trial?

The very purpose of trials is to gain new knowledge about new treatments that might benefit future patients. But in the trial, the new treatment is still under investigation to see how well it works. Although “new” often implies “better” in our culture, the fact is that until clinical research on a new treatment is complete, we do not know if it is better, the same as, or worse than standard treatments. Sometimes, treatments publicized as “promising” or “breakthrough” do not fulfill their promise. The only way to find out is through well-designed and well-conducted clinical trials.

Is participating in a trial different from receiving treatment outside of a clinical trial?

From the ECRI Institute. Used with permission. www.ecri.org.


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