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More Related Information

Why participate in a clinical trial?

(HealthDay News) -- Though participants may have their own personal reasons for taking part in a clinical trial, common ones, according to the U.S. National Institutes of Health, include:

  • Playing a more active role in their own health care.
  • Gaining access to new research treatments before they are widely available.
  • Obtaining expert medical care at leading health-care facilities during the trial.
  • Helping others by contributing to medical research.

For women considering whether a breast cancer trial might be right for them, NIH offers answers to several commonly asked questions:

Just what is a clinical trial?

Definitions abound, but clinical trials generally are considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Some are known as interventional studies; participants in these are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Others are observational studies, in which individuals are observed and their outcomes are measured by the investigators.

Who can participate?

All clinical trials have guidelines about who can participate. Using what's known as inclusion and exclusion criteria -- factors that allow people to participate or bar them from doing so -- help produce reliable results. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the trial, and others need healthy participants. The criteria are not used to reject people personally but rather to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What are the risks of participating in a clinical trial?

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The study protocol may require more time and attention than would other treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
  • What should you consider before participating in a trial?

Learn as much as possible about the specific trial, including the care you can expect while in the trial and the cost of the trial. A discussion with the trial's health-care team should include such questions as:

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects and benefits in the study compare with your current treatment?
  • How might this trial affect your daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment? Will you be reimbursed for other expenses?
  • What type of long-term follow-up care is part of the study?
  • How will you know that the experimental treatment is working? Will you be given the results of the trial?
  • Who will be in charge of your care?

Where is more information available?

NIH has details on the different types of clinical trials, an explanation of the phases of clinical trials and answers to many frequently asked questions at a website devoted to clinical trials,




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