Clinical Trials

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Question

I am considering participating in a clinical trial for a new medication. What kind of information should I have before I agree?

Answer

A clinical trial is generally defined as a biomedical or health-related research study that follows a protocol that has been defined in advance of the start of the study.

Anyone considering clinical trial participation should get as much information as possible in order to make an informed decision. The National Institutes of Health recommends you ask these questions:

  • 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 my current treatment?

  • How might this trial affect my daily life?

  • How long will the trial last?

  • Will hospitalization be required?

  • Who will pay for the experimental treatment?

  • Will I be reimbursed for other expenses?

  • What type of long-term, follow-up care is part of this study?

  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?

  • Who will be in charge of my care?

For more information on clinical trials, visit www.clinicaltrials.gov, which is a registry of federally and privately supported clinical trials being held in the U.S. and worldwide. You can find out about a trial's purpose, potential participants, locations, and phone numbers for more details. Be sure to discuss this with your physician and family.

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