Clinical Trials
A clinical trial is a carefully designed research study that investigates the effectiveness of a specific treatment for a particular group of people. Well-designed clinical trials are the fastest way to find effective treatments. Participants are closely monitored by knowledgeable, experienced physicians and healthcare professionals, including clinical research coordinators.
What Can I Expect from a Clinical Trial?
While each clinical trial is different, you generally will work with a healthcare team that includes a doctor and a research coordinator. This team will follow research protocols where all participants in an assigned group get the same tests and treatment. The team will check your health, carefully monitor you during the study, and follow up after the study. It’s important to take all prescribed treatments and keep all scheduled visits.
Be sure to have any questions about the study answered by your doctor or healthcare professional so that you can make an informed choice. If you’re eligible and wish to enroll, you will be asked to review and sign a consent form.
Participants may be assigned to a group that receives a placebo (an inactive treatment) or an existing treatment instead of the investigational treatment to help determine its effectiveness. In this situation, you will receive the same careful medical attention. To avoid bias, your doctor may not know which treatment you are receiving.
Enrolling in a trial is strictly voluntary and you may withdraw for any reason.
Clinical trials usually involve three phases. In Phase I, a small number of participants are tested to assess drug safety. Phase II tests the ideal drug dosage and Phase III is a larger study to assess both safety and efficacy.
To provide an added level of safety and oversight, all clinical trials are approved by an independent Institutional Review Board (IRB). Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Benefits of Clinical Trials
Participating in a clinical trial has many potential benefits. These include:
- Access to the latest treatments before they are widely available
- Possible compensation for your time and reimbursement for extra services
- Closer monitoring of your condition by expert medical professionals
- Improved medical knowledge that can benefit others
There are some potential drawbacks of clinical trials, as a new treatment may not benefit you even if it benefits others. In other cases, treatments may prove less beneficial than doctors hope and even less effective than an existing treatment. There is a possibility of unanticipated side effects that involve more frequent visits to your physician’s office.