What to Expect During a Clinical Trial

If you are unfamiliar with a clinical trial, this page describes the players and process of a clinical trial.

The People

A clinical trial is designed by a sponsor. A sponsor is typically a pharmaceutical company with a new product or an existing product that they would like to test. The sponsor contracts with a physician investigator who is a doctor that actually runs the clinical trial. An investigator will have help from various people, including a project manager that manages the trial and clinicians who are medical personnel that perform the study procedures.

Subjects are people who volunteer to undergo the procedures in the trial. The rights of the subjects are protected by an independent review board (IRB). The IRB makes sure the clinical trial and the physician investigator are acting ethically and that the subjects are properly protected.

Finally, the Food and Drug Administration (FDA) is a government agency that reviews each clinical trial before and after it is run to make sure the trial is run according to the guidelines and laws developed by the government.

The Medical Procedures

Each clinical study is described by a document called a protocol. Protocols describe what type of subjects can and can't be enrolled into the study. The protocol also includes information like the study schedule, a list of the procedures to perform, and any laboratory tests to be run. Each protocol is different. Before you enter a trial, the physician investigator will describe to you the procedures, risks and benefits during the informed consent process.

Even though every trial is different, you can expect to have some blood draws and urine specimens taken. Depending on the trial, sometimes the meals you are served will also be determined by the protocol. How often this happens depends on the study or visit schedule. The physician investigator will explain the visit schedule to you during the informed consent process. Most of our healthy trials require that you stay one or more nights in our research facility.

About the Research Facility

A clinical trial takes place in research facility. At Healthcare Discoveries, our volunteers have semi-private rooms equipped with cable television and a video player. Additionally, there are patient recreation areas that include such items as:

"Nintendo-style" gaming system
pool table
ping-pong
foosball
books
board games

24x7 high-speed Internet access is available to all participants. Study-compliant meals are prepared at area restaurants and served in our dedicated dining room.