What to Expect During a Clinical Trial

While numerous treatments are currently available for most types of medical conditions, a number of new approaches and drugs are currently under development. Each new treatment must pass a rigorous clinical trial before the Food and Drug Administration (FDA) approves it.

Each study is a little different, depending on the type of treatment. Some studies determine the effectiveness of oral medications, for example, while others may assess the benefits of an injectable. If you join a clinical trial, you can expect the study to include the following aspects.

Clinical Visits

Depending on the type of study, you’ll probably be asked to come into the clinic or hospital that is conducting the study once or twice a month for the duration of the study. The length of a study varies. A study must last long enough to gather good information, but it is in everyone’s interest to make the study as quick as possible.

Informed Consent

During your first visit, you will be asked to read some information about any medical interventions that will be used during the study, and how the study is conducted. Once you have read the form and asked any questions that you may have, you’ll be asked to sign the Informed Consent form to indicate that you understand its contents.

Medical History

During your first visit to the clinic, you’ll be asked to fill out a form on your medical history, including any health problems that you have or used to have, any medications that you are taking or have taken, and some questions about the health of your relatives.

Physical Exam

During your first and last visit the clinic will give you a complete body physical examination.

Pregnancy Test

If you are a woman of childbearing age, the clinic may give you a pregnancy test.

ElectroCardioGram (ECG)

During your last visit, you will probably be connected to a machine that will record how your heart is working. This is completely painless.

Vital Signs

Basic details of your current health, such as blood pressure, pulse rate, and temperature will be taken during your visits to the clinic.

Ongoing Assessment

You will probably be asked each visit about any adverse events that you have experienced. You may be asked to keep a diary and complete a questionnaire.

Samples and Lab Tests

You will be asked to provide a blood sample on some visits. Various tests will be performed on the samples as part of the monitoring of your physical condition

A Stipend

You’ll probably receive a monetary reward for your participation in the study. This will be given to you during each visit to the clinic. You may receive additional payments for special procedures that the doctor may require to check your health.