Clinical Trials

About Clinical Trials: Questions to Consider

  • What is the purpose of the trial and what do they expect to learn?
  • What are the reasons why it might make sense for me to be part of this trial?
  • What phase is the trial?
  • Who is going to be in the trial?
  • How big is the trial?
  • How many will be in the trial?
  • Is it being conducted in one place or in many places?
  • Who is sponsoring or paying for the study? Do any of the members of the research team:
    - Have a financial interest in the outcome of the study
    - Own stock in the company testing the drug or medical device?
    - Receive money for any reason from the company making the medicine or medical device?
  • What conflict of interest policies are in place at this location?
  • What kinds of tests and treatments are involved?
  • Why do researchers believe the treatment being tested may be effective? How likely is it that I will experience a benefit?
  • Have there been similar studies that used the same type of drugs, devices, etc? What happened in those studies?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • Will everyone in the trial receive the same drugs, devices, procedures or will there be different groups that are treated differently? If so:
    - Is it possible that I won't receive the experimental treatment even if I'm in the study?
    - Will the research team know what group I'm in?
    - In an emergency, can someone find out what group I've been in and share the information with my doctor?
  • How will they monitor my safety during the trial?
  • What are the risks and how likely is it that I'll experience a problem? What happens then?
  • Will any of the procedures or tests that are part of the study hurt or cause me discomfort? If so, how much and for how long?
  • Will being in the study mean that there are drugs or treatments I won't be able to have?
  • Could my condition get worse during the study? What will happen if it does?
  • Will hospitalization be required?
  • How many times will I have to visit the hospital or doctor's office during the study? How long would each visit be?
  • Will I have to fill out any paperwork during the study? How much?
  • Who will be in charge of my care?
    - Will I continue to see my current medical team during the study?
    - How will the study staff work with my primary physician to keep him or her informed about my care?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • What type of long-term follow up care is part of this study?
  • Who will pay for the treatment?
  • Will I be paid for participation or reimbursed for out-of-pocket expenses?
  • Who would be able to look at the records of my participation in the research?
  • Will results of the trials be provided to me? If so, when?
  • How much time do I have before I must decide?
  • If I enroll in a study, can I change my mind?
  • What other options are available if I don't participate in the study?

Reprinted with permission.  To see full article, visit http://secondopinion-tv.org/episode/clinical-trials-parkinsons-disease.

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