Q&A About Clinical Trials
What is a Clinical Trial?
A clinical trial, also referred to as a research study, is a scientific study that evaluates the safety and effectiveness of an investigational medication. A clinical trial may show that the investigational medication is better than, as good as, or no better than the standard treatment or inactive placebo. Qualified doctors, nurses and other medical professional conduct the study itself.
It is only through the completion of clinical trials that investigational medications can be evaluated, and if proven safe and effective, approved for general use by the U. S. Food and Drug Administration (FDA). All prescription medications in use today were first proven safe and effective in clinical trials.
For more information about clinical studies or to find one that might be right for you, please visit www.clinicaltrials.gov
Who Oversees Research Studies?
To help ensure that a clinical research study is ethical and that volunteers' rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.
Who Can Participate in a Clinical Trial?
Only volunteers who meet all of the eligibility criteria for a study may take part. The medical research study team at a study office selected by a prospective participant reviews his or her medical history and current medical status against the eligibility criteria. They determine if the individual qualifies to participate in the study. Prospective study participants may also be asked to provide information from their medical records to help the medical research study team determine if they qualify.
What is a Placebo?
A placebo, also known as a "sugar pill", contains no active medication. A placebo is used in clinical trials to determine if the active medication being evaluated is safer and more effective than no treatment at all.
Can a Study Participant Withdraw From a Study After Having Started?
Participation in a study is entirely voluntary and a participant may withdraw at any time. If an individual decides to withdraw early from the study, he or she will be asked to notify the research staff before doing so, and will usually be asked to return to the study office at least once to complete a final visit and return any unused study medications.
Does One Have to Pay to Participate in Clinical Trials?
There is no charge for taking part. All examinations, physician visits, procedures and medications related to the study are provided at no charge.
Does a prospective study participant’s doctor have to give permission for someone to participate in a clinical trial?
A prospective study participant’s doctor does not have to give his/her permission for someone to take part. However, either the individual or the physician conducting the study, with his or her permission, may contact their personal physician to discuss participation in the study before beginning and to keep his or her doctor up-to-date about their progress.