CFEF

 Center for Emotional Fitness

FAQs – FREQUENTLY ASKED QUESTIONS…

What Are Clinical Trials?

How do I Know If I'm Eligible for a Clinical Trial?

Who Decides What Drug I Will Get During a Clinical Study?

Do Researchers Protect My Confidential Medical Information?

How Are Clinical Trials Financed?

What Happens If I Want to Leave a Clinical Trial?

 

1.  What Are Clinical Trials?

Clinical trials are research studies that investigate new or existing pharmaceutical treatments. Most commonly, clinical trials are used to determine whether a new drug is safe and effective, as this type of testing is required by the US Food and Drug Administration (FDA) prior to gaining approval for sale of new drugs within the United States.

Although participation in clinical trials is not suitable for all individuals, many individuals find that clinical trials offer a cost-free opportunity to treat medical problems using leading-edge treatments not otherwise available.

Prior to entering a clinical study, you will be fully informed of all study procedures, possible risks and benefits of treatment, and the availability of alternative treatments, so that you can make an informed choice about the suitability of a clinical study for your particular condition.

In most clinical trials, the main researcher (often called the Principal Investigator) is a physician, although psychologists, nurses, laboratory technicians, and clinical research coordinators and associates also provide important study functions.

2.  How do I Know If I'm Eligible for a Clinical Trial?

Some research programs enroll only healthy people, while others enroll only patients with particular problems or diseases. The researchers who conduct the clinical trials establish these and other guidelines at the outset of the study in order to ensure that they will gather useful and valid results. If you meet the study's guidelines for inclusion in the study, and do not meet any of the studies reasons for exclusion, you are eligible to join.

4. Do Researchers Protect My Confidential Medical Information?

As a participant in a clinical trial, you will never be identified by name in any paper published about the clinical trial. Although the FDA can inspect the medical records of participants who participate in clinical trials, federal law protects that information from being used elsewhere.

During the "informed consent" process, which occurs prior to any study-related procedure, researchers will tell you how your research materials will be handled and safeguarded. In written documents, researchers always identify patients by their initials and assigned study numbers rather than by names.

5. How Are Clinical Trials Financed?

In the United States, most clinical trials that involve pharmaceutical agents are sponsored by drug manufacturers. Such sponsors pay teams of investigators to conduct and oversee the clinical trials. Researchers and sponsors negotiate many kinds of financial arrangements, and in many cases, researchers also pay patients who participate in a clinical trial.

3. Who Decides What Drug I Will Get During a Clinical Study?

Many clinical trials test a new drug against a placebo (sometimes called a "sugar pill"), which looks just like the real drug but doesn't contain any active ingredients. Other clinical trials test two different drugs to see how they compare. Many clinical studies are randomized, which means that participants are randomly assigned to one treatment or the other (for example, to take either the active drug or the placebo). Other clinical trials compare different doses of the same drug to learn which dose is the most effective.

 

6. What Happens If I Want to Leave a Clinical Trial?

You are always free to leave a clinical trial for any reason. The informed consent document that you sign does not force you to remain in a trial. If you do leave a clinical trial, it is usually helpful to let the researchers know why you are leaving, although this is not required.

7. Can I Be Forced to Leave a Clinical Trial?

Although researchers make great efforts to help you complete clinical trials, there are some occasions that require a patient to be withdrawn from a study. For example, if a participant violates the requirements of the clinical study by intentionally taking a restricted medication, that participant would be removed from the study.

In addition, researchers may end your participation in a clinical trial for other reasons, including (a) changes in your health that disqualify you based upon the study's inclusion and exclusion criteria, (b) a sponsor's decision to end the clinical trial because enough data has been collected, or (c) the acquisition of new information that makes the research study unnecessary or risky.