Clinical Trials

When you join a clinical trial, you are volunteering to test a new treatment, often a new drug or new combination of drugs. You are also agreeing to follow the rules set out by trial researchers. These rules are called protocols and may include how the treatments are to be administered, risks and benefits, how data will be collected, and the goals of the study. The trial will have a specific start and end date.

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The Food and Drug Administration regulates clinical trials in the U.S., and these trials are required before a new treatment can be approved and marketed to consumers.

Each clinical trial is different and will have different eligibility criteria that must be met by participants. In general, you must have the condition the treatment aims to address, and you must be willing to undergo the treatments exactly as designated by the trial protocol. Other common eligibility criteria often include age and gender.

If the research study you join includes the use of a placebo – a sugar or “dummy” pill – you will not be told whether you are getting the drug being tested or a placebo. In many cases, the trial may be
“double-blind,” meaning the doctor also will not know whether you received the real drug or a dummy. Often, participants are not informed about whether they received a placebo until after the trial is completed.

Depending on the drug being tested, a research trial may require that you stop taking certain medications during the course of the trial. You should consult your family doctor before joining any clinical trial to ensure it is medically safe for you to do so.

If you participate in a clinical trial, the treatment being tested may improve your condition, worsen your condition, have no effect on you at all, or result in unanticipated side effects.

If you are considering participating in a clinical trial, be sure to talk it over with your family doctor to make sure it is safe and appropriate for you. The trial protocol should provide information about any expected side effects as a result of participation.

Clinical trials are used to study the effects of a new treatment.

When you join a clinical trial, your health, safety, and well-being are protected in a number of ways, including:

• Your family doctor can identify whether you might qualify for and benefit from a particular clinical trial. You should always consult a doctor familiar with you and your medical history before you decide to participate in any type of medical research study. Your doctor will also closely monitor your health before, during, and after your participation in a clinical trial.
• Trial protocol should identify possible risks or adverse events to patient participants. Be sure you understand the protocol before joining a trial.
• The informed consent process assures that you are aware of potential risks of a clinical trial and have had the opportunity to ask questions.
• There are people and processes in place to regularly monitor your health and well-being during and after a clinical trial. In addition to your family doctor, these include:
• Clinical investigators are a part of the trial team and are required to monitor each and every participant to ensure their safety.
• The principal investigator (head researcher for a study) is responsible for ensuring strict safety rules are followed throughout the course of the trial.
• The Institutional Review Board (IRB) consists of doctors, scientists, and lay persons who must approve a clinical trial before it can be performed. The IRB is dedicated to ensuring participants are not exposed to unnecessary risks.
• A Data and Safety Monitoring Committee may supervise your clinical trial. When this is the case, its members – experts in the condition being treated – will periodically review the progress of an ongoing trial. If the drug being tested is either not working or causing harm to participants, the trial will be immediately stopped.

Yes, you have the right to opt out of a clinical trial, for any reason, at any time.

Each clinical trial is different. You will be informed before the trial begins whether continuing on the treatment being tested is an option available to you after the trial is over. The informed consent process should outline this, and state exactly how it may be done.

In some cases, the drug manufacturer may allow trial participants to continue testing the drug. In others, you may be prescribed something similar that is already FDA approved until the pharmaceutical being tested receives FDA approval. Keep in mind that FDA approval is not guaranteed; some clinical trial treatments never receive FDA approval for a variety of reasons.

What do I get out of participating?

The most immediate benefit to you is access to a treatment that isn’t yet available in the marketplace. Your North Texas Family Medicine doctor will continue to monitor your progress throughout your participation in the trial. The cost of the medication is typically waived for patient participants – and sometimes a stipend may even be available to clinical trial participants.

In the broadest sense, you are helping to save future lives by contributing to the effort to better identify, prevent, or treat the condition under study.

The most immediate benefit to you is access to a treatment that isn’t yet available in the marketplace. Your North Texas Family Medicine doctor will continue to monitor your progress throughout your participation in the trial. The cost of the medication is typically waived for patient participants – and sometimes a stipend may even be available to clinical trial participants.

In the broadest sense, you are helping to save future lives by contributing to the effort to better identify, prevent, or treat the condition under study.