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Phoenix Clinical Research, LLC: Frequently Asked Questions

What is a clinical research trial?

A clinical research trial, sometimes also known as a clinical research study, is research that is designed to determine whether a new medication or device is safe and effective for people to use. Once the medication or device is found to be safe and effective, it may become available for doctors to prescribe.

Why should I volunteer to be a subject in one of these studies?

Clinical trials are the safest and quickest way we have of determining what new products are safe and effective; trials are carefully designed, strictly controlled, and constantly overseen. Study volunteers help themselves and others by participating in medical research which, in turn, advances medical science. Without volunteers, new products cannot be approved for general use.

Are clinical trials safe?

Rules for clinical research studies and the researchers performing studies are set by the Federal Drug Administration (FDA) and were created to protect study participants and ensure that they are treated as safely as possible. Additionally, medical ethics groups oversee clinical trials from the time they are first proposed through completion.

What kinds of questions should I be asking about a study before deciding whether I want to be a volunteer?

You should ask the following types of questions:

• the purpose of the study
• how long you will be in the study
• the kinds of procedures that will be performed
• whether there is a chance you will receive a placebo (a sugar pill without medicinal value) rather than the study drug
• what possible benefits, risks and side effects you might experience
• what other treatment options are available to you
• confidentiality of your medical records
• whether your medical expenses will be covered if you are injured as a result of participation in the study

How does a clinical trial work?

Clinical trials are overseen by doctors and researchers who work with other health care professionals as a team to conduct the study. Volunteers generally meet with a member of the research team who will explain the study. If you wish to participate, you will be given an informed consent form to read and sign. This form describes the study, what your participation will entail, any procedures to be performed and any potential risks and benefits of participating as a volunteer. Once the informed consent has been signed, you will be asked for information to determine if you meet the requirements for study participants. Once it has been determined that you meet the eligibility criteria, you can be enrolled in the study.

What benefits do I get by enrolling as a volunteer in a clinical trial?

Aside from knowing that you are advancing medical science, volunteers may also benefit in various ways ranging from having access to new medications and/or devices before those products become widely available and obtaining study materials and medical care during the trial.

What risks might I run by enrolling as a volunteer in a clinical trial?

Depending on the product being studied, some of the risks with clinical research may include:

• additional treatments
• additional time and/or visits to your physician
• longer hospital stays
• the chance that you may be in a study group which does not receive the medication or product being studied
• possible unpleasant, annoying, serious or life-threatening conditions or side effects from the product being studied and/or procedures used to study it
• ineffectiveness of the product being studied

This list is a list of possibilities and is not intended to be exclusive or exhaustive.

If I volunteer and then later change my mind, can I leave the clinical trial once it has started?

Yes. Volunteers can decide to terminate their participation in a clinical trial at any time. If a volunteer decides to leave a study, they are asked to advise the researcher and provide their reason for terminating their participation. It may be necessary to perform early termination procedures to ensure that a volunteer leaves the study in a safe manner.

Who pays for clinical research studies to be conducted?

Clinical trials are generally sponsored by pharmaceutical manufacturers, various medical organizations, and various government agencies.

How can I learn more about clinical trials?

The following are some of the organizations that you can contact for more information on clinical research trials:

ClincalTrials.gov–This is an online database managed by the National Library of Medicine where you can find information about federal and private clinical research trials. It provides information such as the purpose of a trial, eligibility, research locations, and contact information.

CenterWatch–This website provides clinical research information for both patients and researchers. Patients can find information on clinical trials and drugs, among other topics.

Center for Information and Study on Clinical Research Participation– The CISCRP is a non-profit organization that has a purpose of educating the public about participation in clinical research. Their website address is www.ciscrp.org. They can also be contacted by phone at 1.888.247.2773.