Participation Information

Who can participate in a clinical research study?

All clinical trials have guidelines about who can participate. The Inclusion/Exclusion criteria are a very important principle in a clinical trial. The inclusion criteria allow someone to participate and the exclusion criteria disallow someone to participate. These criteria is based on such factors as age, gender, the type and stage of the disease, previous treatment history, medications that a patient is currently on and other medical conditions. Before a person can join a clinical trial they must qualify for the study and have all medical conditions considered before being enrolled in the study.

Why should you participate in a research study?

There are many reasons why a person would want to participate in a clinical trial. Many people participate in phase II and III trials to gain access to promising drugs that are not available to the public. All patients receive excellent care from the physician and staff during their participation and it may be at no charge to them.

Research studies also include volunteers who want to advance the medical research process. Patients often want to contribute to their current treatment options. Through participation in a research study their opinions help shape medical options for years to come.

What are the risks involved in a research study?

There could be some unexpected or unwanted side effects to an investigational product and you may not receive the intended benefit for the investigational product. However, the U.S. Food and Drug Administration and the Institution Review Board monitor each research study closely. Studies that seem unsafe or unethical are not conducted. The physician and their staff closely monitor your health status and response to the study's drug throughout your participation. All benefits and risks are discussed and written out for you in what is called the 'Informed Consent Form.' This is a very detailed form that will answer all your questions about the research study.

What kind of preparatory questions should I ask the research team before participating in a research trial?

Ask a friend or relative to come along to the meeting for support and also to ask questions about the trial. Always bring a list of your current medications and previous medical history and treatments. Plan to write down any questions you might have before your meeting.

What is the purpose of the study?
Has the investigational product been tested on humans before?
How long will the trial last? How many visits are required?
Who will pay for the treatments?
Will I be reimbursed for my time and travel?

These are just a few examples of questions you should be asking. Bring a list of any doctors that you would like us to inform about your participation in the trial. (Please include addresses and phone numbers.

 

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