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Questions to Ask Before You Participate in a Clinical Trial

These Questions Will Help You Decide if Participation is Right for You

By

Updated February 20, 2011

When considering participation in a clinical trial, you'll want to ask questions to help you determine whether you want to participate and whether you can commit to the terms of the trial.

Before you participate in a clinical trial, you'll be asked to sign an Informed Consent document. Knowing the answers to the questions will help you feel truly informed.

Here are some of the questions you may want to ask of either your primary care physician, the specialist you work with or the investigators hosting the trial:

What is the purpose of the trial?

What do investigators hope to prove?

What is the profile of the participants?

What characteristics will include or exclude a participant? These may be features such as age, gender, race, diagnosis, previous treatment, even location. Do you fit the profile? If not, then you will not be considered as a possible participant.

Has the protocol, drug, device or therapy been tested before?

This answer will depend on the phase (I, II, III or IV) of the trial.

What are the possible risks and side effects?

And, what are the contraindications? You may have bad reactions. Other reactions may not bother you at all. You'll want to assess the possibilities.

What are the benefits of participating in this particular trial?

Some benefits will be universal to all clinical trials. Others will be based on your personal situation.

Will your participation remain confidential and private?

You will want to know that information about your participation, especially any results or outcomes, will follow all HIPAA privacy laws.

How will this trial affect your daily activities?

How much time will it take each day, week or month, and will you have to change any of your routines to accommodate the trial?

How long will the trial last?

Some trials are finished in an afternoon. Others take years. You'll want to have an idea of the depth of your time commitment to the trial.

Will you need to be hospitalized?

Spending time in the hospital will, of course, remove you from your daily routine, including time away from work if you are employed. This will have an impact on many aspects of your life, possibly including your income, and could be a major aspect of your decision-making about participation in a trial.

How will the costs of the protocol, drugs or devices be handled?

And what about other costs, such as transportation?

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