How Clinical Trials Work
Clinical trials are an important part of making sure the drugs and medical treatments we all use are safe and effective. We conduct trials to predict how well a medication or therapy will perform in the general population when used to treat a certain condition.
Every FDA approved medication or treatment available today has at some time been tested in a clinical trial. Sometimes medications or treatments already being used may be tested again for treating additional illnesses.
Our clinical trials measure the safety and effectiveness of a proposed medication or treatment, compared to a placebo or to existing therapies. While most of our trials compare single medications, others compare combinations of different medications, or various dosage levels.
Depending on the stage of a drug or treatment’s development, trials usually start as small pilot studies. As safety and effectiveness data are established, trials can be much larger, sometimes involving many thousands of volunteers in different locations, or sites.
All clinical trials involve three steps:
1. Recruiting volunteers: Our first job is to recruit volunteers to join a study and to retain them for the entire length of the trial (usually several months, but sometimes longer). We carefully screen all volunteers to make sure they are generally healthy, and/or have the characteristics desired by the study sponsor.
2. Conducting the trial: Each trial is conducted according to precise methods called protocols, as determined by the trial’s sponsor (usually a drug company). Since many trials involve conducting studies in different sites at the same time, a protocol insures that the studies are all performed in the same way at each site. If one site cannot recruit enough trial volunteers, the sponsor may engage multiple sites.
3. Collecting information: We collect detailed medical information on the changes volunteers experience while using a medication or treatment. We verify the information for accuracy and then report it to the trial Sponsor. We report only medical information (blood pressure, lab values, etc.) for each volunteer, not their personal information (name, address, etc.). Once the sponsor has gathered the trial information from all sites, the information is combined and carefully analyzed before being submitted to the FDA for review and approval. If approved by the FDA, the drug or therapy may be released for general use.
We carefully measure the safety of investigational medications or treatments. By regularly and thoroughly monitoring study participants, we keep a very close watch for any unusual or unexpected side effects that may arise during the trial.
Any side effects, even minor ones, are recorded and included in the Sponsor’s analysis. When a treatment is approved by the FDA, all observed side effects are listed in the package insert (patient information sheet) that is included with the treatment. You receive this information each time you purchase a prescription medication at your pharmacy.