Participation and Expectations

Who Can Participate in Clinical Trials?

Each clinical trial is designed to study a specific sub-group of the population and includes eligibility criteria to ensure the trial comprises the patients for whom the investigational treatment is designed. Sometimes, the eligibility criteria focus on patients who are generally healthier, in case there are unexpected side-effects associated with treatment. To determine if you are eligible for a trial, the principal investigator (the doctor conducting the clinical trial) will “screen” you to see if you meet the eligibility requirements. The screening may include a review of your medical records; a verbal discussion about your health, previous treatments, and symptoms; bloodwork; and additional tests and scans. If you are eligible for the trial, then it is time for you to make a decision about participating. Participation in clinical trials is 100 percent voluntary, and you may withdraw from a trial at any time for any reason.

What Can Patients Expect in a Clinical Trial?

Researchers rely on medical organizations, such as cancer centers, hospitals and medical centers, to find clinical trial participants.

If you join a trial, you will continue to receive care from your primary physician. But not all clinical trials are available everywhere, so you may need to travel and/or you may need to be seen at the center where the trial of interest is being conducted. Because researchers need to monitor the effects of a treatment to assess it, you may have to undergo additional blood tests, biopsies or checkups.

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Questions to Ask

Choosing a treatment direction, including whether or not to enter into a clinical trial, is a big decision. By being more informed about the options you are considering you will be empowered to make the best decision possible for yourself.

The National Cancer Institute recommends asking the following questions as you are deciding to participate in a clinical trial:

Questions about the Trial

  • What is the purpose of the trial?
  • Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
  • How long will I be in the trial?
  • What kinds of tests and treatments are involved?
  • How will the doctor know if the treatment is working?
  • How will I be told about the trial’s results?
  • How long do I have to make up my mind about joining this trial?
  • Who can I speak with about questions I have during and after the trial?
  • Who will be in charge of my care?
  • Is there someone I can talk to who has been in the trial?

Questions about Risks and Benefits

  • What are the possible side effects or risks of the new treatment?
  • What are the possible benefits?
  • How do the possible risks and benefits of this trial compare to those of the standard treatment?

Questions about Your Rights

  • How will my health information be kept private?
  • What happens if I decide to leave the trial?

Questions about Costs

  • Will I have to pay for any of the treatments or tests?
  • What costs will my health insurance cover?
  • Who pays if I’m injured in the trial?
  • Who can help answer any questions from my insurance company?

Questions about Daily Life

  • How could the trial affect my daily life?
  • How often will I have to come to the hospital or clinic?
  • Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
  • Will I have to travel long distances?
  • Will I have check-ups after the trial?

Questions about Comparing Choices

  • What are my other treatment choices, including standard treatments?
  • How does the treatment I would receive in this trial compare with the other treatment choices?
  • What will happen to my cancer without treatment?
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