What to Expect When Participating in a Clinical Trial

The experience of a clinical participant will vary greatly depending upon the type of research being conducted in the relevant clinical trial. There may also be regional differences. For example, a clinical trial in Birmingham may be different that a trial in Anaheim.

The number of diagnostic tests and doctor visits required may vary depending on the type of clinical trial being conducted. It can also vary depending on what the research staff deems necessary. These tests are a very important part of clinical trial participation and ensuring each participant’s health and safety.

As the role of the site staff is to safeguard the volunteers’ health throughout the trial, guide the volunteers with specific instructions and make sure that the study protocol is carefully followed, the requirements the site staff places on the participant will vary from trial to trial.

Types of clinical trials include:

• Treatment trials: test trial treatments, new mixtures of drugs or new methods for surgery or therapy; typically run for 3-7 years.
• Prevention trials: test for improved ways to prevent a disease from reoccurring; typically run for 10-20 years in order to evaluate the long-term implications of lifestyle changes such as exercise or diet.
• Diagnostic trials: search for more useful medical tests or procedures for diagnosing specific medical conditions.
• Screening trials: test for the ideal method of identifying certain diseases or medical conditions.
• Quality of life trials: search for ways to maximize comfort and the quality of life for people with chronic illnesses.

Before a volunteer can join a trial, a screening process is performed to check his weight, blood pressure and temperature. Further, the site staff will likely perform a blood test, urinalysis, electrocardiogram, and other medical tests as required by the study protocol to ensure that his enrollment is safe and suitable.

If all of the volunteer’s test results meet the requirements for the clinical trial, the site staff will contact him to schedule trial-related clinic visits and discuss participation requirements in more detail. As enrollment in a clinical trial is completely voluntary, a participant may leave the trial at any time, and for any reason. Before joining the trial, every volunteer must sign a consent form.

It is important to note that most clinical trials are “randomized”, meaning that while 60-70% of the volunteers are given the trial drug, some of the volunteers will be given a placebo drug and others may be given the FDA approved standard course of treatment. The randomized nature of clinical trials allows for an accurate comparative study of the control group relative to the success and side effects of the group being given the new product.

Clinical trials conducted for new drugs have four phases; beginning with a small group, the trial progresses to bigger trials and post-approval follow-up trials to test side effects and refine dosages. Not all tested drugs and medical devices make it through the entire protocol due to complications that often arise as the trials progress. If a serious problem should arise, the trial in question may be permanently ended or tentatively arrested until the issue is resolved.