Should I Take Part in a Clinical Trial?

CURE, Summer 2007, Volume 6, Issue 4

Questions to ask yourself before enrolling in a clinical trial.

Why do I want to take part in a clinical trial?

What are my goals and expectations if I decide to participate? How realistic are these?

How sure are my doctors about what my future holds if I decide to participate? If I decide not to participate?

Have I considered the chance of benefit versus risk? Other possible factors, such as time and money? My other possible options?

What are my clinical trial options regarding access? Do members of my health care team participate in clinical trials? If so, what type of trials are they involved in?

Who is running this study and what is its purpose? Is the purpose to determine the safest dosage of a new drug or to determine the most effective treatment for my cancer?

Who is sponsoring the study? Has it been reviewed by an institutional review board?

How does this trial treatment compare to other treatments?

What results could I reasonably expect from the trial treatment?

What treatment plan would I pursue if I didn’t join the study?

How would being in the study affect my daily life? Would I be able to continue work? Would I feel like pursuing social activities?

Would I have to be hospitalized? How often and for how long?

What kinds of additional tests, such as blood tests or biopsies, would I undergo for the specific purpose of the study? Do any of these have side effects or risks that are of particular concern to me?How long will these extra visits take?

How long would my active participation in the study last?

What are the potential short-term and long-term side effects of the treatments being tested? Are any of them likely to be permanent or life threatening? Would I be allowed to take medications to alleviate side effects?

How and where would my response to the trial treatment be evaluated?

Where would I be treated and evaluated? Would I have to travel? How frequently?

How would I know if the treatment was working properly or if I was responding? How would I determine whether I should receive a different treatment plan from the one being studied?

Who would look out for my care?

What type of follow-up care would I receive after the study is completed?

How much would my personal physician be involved in my care?

Who would be professionally responsible for my health care while I am in the trial?

Would any or all of the costs be covered? If not, are there other sources I can turn to for financial help?

Will I be informed of any findings from the study that might affect my willingness to stay on the study, such as side effects that are discovered?

What factors will determine how long I participate in the study?

Will I be given the results of the overall study, and if so, when?

Reprinted with permission from the American Cancer Society