Understanding Clinical Research Trials
Well-conducted clinical trials are the fastest and safest way to reach early prevention, early diagnosis, and early treatment.
What is a Clinical Research Trial?
Although there are many definitions of clinical trials, it is a scientific investigation of a medication or treatment in human beings that follow a pre-defined protocol. Through clinical trials, doctors help find possible new ways to prevent, detect, diagnose, control, and treat illnesses. Before a new medication can be approved for the use by the public, it must be tested according to strict guidelines established by the U.S. Food and Drug Administration (FDA). Participation in clinical trials is completely voluntary and all information provided by a participant is kept strictly confidential and used only for the purposes of conducting the study as required.
What is Informed Consent?
Informed consent it the process of learning the key facts about a clinical trial before deciding whether or not one would like to participate in a clinical trial. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study provided. Then, the research team provides an informed consent document that includes details about the study such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in the informed consent document. The participant can then decide whether or not he or she wants to sign the document in agreement to the terms written. Informed consent documents are not contracts and the participant may withdraw from the trail at any time.
Things to Consider Before Participating in a Clinical Trial:
People should know as much as possible about the clinical trial and feel comfortable asking any member of the research team questions regarding the clinical trial including the care expected while in the trial and the cost of the trial. The following questions may be helpful for the participant to discuss with the research team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective?
- Has it been tested before?
- What kinds of tests are involved?
- How do the possible risks, side effects, and benefits in the study compare to my current treatment?
- How might the trial affect my daily life?
- How long will the trail last?
- Who will pay for the experimental treatment?
- What type of long-term follow up care is part of this study?