Before Entering a Clinical Trial

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Participating in Research

Participating in a research study at the University Hospital is always voluntary. You as the patient must decide on your own if the study is right for you. The three most common reasons people decide to take part in research are:

  1. Hope of some personal therapeutic benefit
  2. Confidence in their physician's recommendation to enter a trial
  3. Hope of benefiting others

The three most common reasons people decide not take part in research are:

  1. Fear of placebo or randomization
  2. To far to travel
  3. Desire to have the physician choose the treatment rather than accept a process that uses randomization to assign patients to a treatment group

OTHER THINGS TO CONSIDER WHEN PARTICIPATING IN A RESEARCH STUDY:

Possible Benefits

  • Participants have access to promising new approaches that are often not available outside the clinical trial setting.
  • The approach being studied may be more effective than the standard approach.
  • Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
  • Participants may be the first to benefit from the new method under study.
  • Results from the study may help others the future.

Possible Risks

  • New drugs or procedures under study are not always better than the standard care to which they are being compared.
  • New treatments may have side effects or risks that doctors do not expect or that are worse than standard care.
  • Participants in randomized trials will not be able to choose the approach they receive.
  • Health insurance and managed care providers may not cover all patient care costs in a study.
  • Participants may be required to make more visits to the doctor than they would if they were not in the clinical trial.

Questions to Ask

In order to decide if the study is right for you, you need to know as much information about the study and its components. Here are some questions you should ask before consenting to participate in the study.

  • What is the purpose of the study?
  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
  • What is the researcher's reason for doing the trial? Is he/she receiving payment for each research subject's participation?
  • How long will the trial last?
  • Where will information from the study go?
  • What other options or choices do I have if I decide not to participate?
  • What is likely to happen to me with or without this treatment?
  • What tests and treatments does the study involve? Will I be hospitalized?
  • What are the short-term and long-term risks and benefits of this trial? What are the possible side effects? How do these compare to my current treatments? How will the trial affect my daily life?
  • Could my condition become worse during the study? What will happen if it does?
  • If I am harmed as a result of the research, what treatment would I receive?
  • What do you do to monitor patient safety throughout the trial?
  • What type of long-term follow up care is part of the study?
  • Who will pay for the treatment and all other expenses related to the study?
  • How can I end my participation in the study if I change my mind?
  • Whom do I contact for questions and information about the study?