Before Participating in a Clinical Trial

Questions to Consider

 

Patients should know as much as possible about the clinical trial and feel comfortable asking questions. The following questions might be helpful for you to ask.

 

   General:

  • What is the purpose of the study?

  • How long will the trial last?

  • Who is going to be in the study?

  • Why do researchers believe this treatment may be effective? Has it been tested before?

  • Do the researchers have any conflicts of interest?

  • Does the referring health care provider receive any compensation?

  • What medical costs are covered? 

  • Will I be reimbursed for other expenses? 

  • How might this trial affect my daily life? 

 

   Treatment specific: 

  • What kinds of tests and treatments are involved?

  • How do the possible risks and benefits compare with my current treatment?

  • Will hospitalization be required?

  • Who will pay for the experimental treatment?

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

  • If the study treatment works, and is good for my health, may I continue receiving the study treatment after the trial is over?

  • How will I know that the experimental treatment is working?

  • Will results of the trials be provided to me? If so, when?

  • Who will be in charge of my care?

  • Is it possible that I will receive a placebo treatment? (A placebo, sometimes called a sugar tablet, contains no medication. Researchers compare the results of the experimental treatment to those of the placebo, to decide if the treatment is effective.)

 

 

Responsibilities of Participating in a Clinical Trial

 

Joining a clinical trial does come with certain responsibilities. You must comply with the prescribed treatment regimen and stay in contact with the research team. It is very important that you notify the research team if any of the following occur:

 

  Important Personal Changes:

 

  • You change doctors

 

  • You change insurance

 

  • You move or change your phone number

 

  • New medications are started

 

  • New treatments are ordered by another doctor

 

  • You consider taking herbs or vitamin supplements

 

 

  Medical Changes:

 

  • Your health changes

 

  • Any unusual side effects

 

  • You are not feeling well

 

  • Your cancer comes back or you develop a new cancer

 

 

What is Informed Consent?

 

Informed consent is the process of learning the important facts about a clinical trial before deciding to participate. The research team provides an informed consent document that includes details about the study, such as:

 

  • Purpose,

 

  • Duration, 

 

  • Required procedures, 

 

  • Important contact information, and 

 

  • Potential risks and benefits. 

 

 

Signing an informed consent document means you understand the possible risks and benefits and agree to participate in a clinical trial. Your level of involvement depends on the type of study. Some studies are as simple as filling out a questionnaire. Other studies may involve more tests and clinic visits than a standard treatment requires.

 

**Do not be scared to ask as many questions as you want.** You should feel completely comfortable with the treatment before signing the informed consent!

 

Patients who enroll in a clinical trial study are treated in the same facilities and seen by the same health-care providers as non-study patients. All patients receive the same high level of care, whether they are in a study or not.

 

Participation in a clinical trial is voluntary and patients may withdraw at any time.

 

 

 

Information used in the develop this page was sourced from the following institutions: The Huntsman Cancer Institute's Clinical Trials Office and the Mayo Clinic.