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Questions to Ask About a Clinical Trial

BY Paul Engstrom
PUBLISHED June 16, 2012

Asking the right questions about a clinical trial sheds light on whether it is the most appropriate one for a particular patient and what will be expected of participants. This helps avoid surprises in the future, such as out-of-pocket treatment costs and unanticipated impacts on daily life.

Ideally, patients learn everything they need to know about a study upfront, as part of informed consent. “But as a practical matter,” says Richard Schilsky, MD, section chief of hematology/oncology at The University of Chicago Medicine, “sometimes the details don’t become obvious until after the patient chooses to participate. Then it’s, ‘Oh, my God. I didn’t know I would have to do that!’”

In fact, studies have shown that many participants don’t always understand the setup of clinical trials, the risks and benefits associated with the trial or the purpose of the trial. The National Cancer Institute and the American Society of Clinical Oncology suggest asking key questions, such as: 

> Why does the research team think the experimental treatment will work?

> Who has reviewed and approved this study?

> Who is sponsoring and funding the trial?

> Will some of the trial participants receive a placebo rather than active treatment?

> What are the treatments, scans and other procedures participants can expect to undergo? Which ones are experimental (specific to the trial) and which are part of normal care?

> What are the short- and long-term benefits and the short- and long-term risks of the treatment?

> Who will supervise the participant’s therapy?

> What expenses, if any, will the insurance provider or the participant have to pay?  

> Where is the study site, and how often will participants have to visit it? 

> How long will the study last?

> How will it affect the participant’s daily life?

It’s OK to contact the research team directly; a phone number should be listed in the clinical trial summary. Ask to speak with the trial, referral or research coordinator, or with the protocol assistant. Research coordinators, who are typically nurses, determine whether willing patients meet the study’s eligibility criteria, make sure the study protocol is followed for each patient and often serve as the link between participants and their physicians.

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