Study patients are the most important part of a trial.
Clinical trials must be conducted before a new drug can enter the market. Drugs that treat specific diseases are constantly being developed which means that there is an ever growing need for recruiting more patients for study participation.
During a clinical trial, study participants will have the chance to receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, known as Principal Investigators to conduct clinical trials to determine the benefits of investigational drugs.
Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must provide consent through the Informed Consent Form. Research sites are able to clarify any questions that a patient might have before beginning a study. The study doctor is also available for any questions and must be seen in order to determine if the patient can qualify for the study. The factors that allow volunteers to participate in a clinical trial are called "inclusion criteria" and the factors that disallow volunteers from participating are called "exclusion criteria." These criteria can include age, gender, the type and stage of a disease, previous treatment history, or other medical conditions.
How does a clinical trial work?
In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available. Each study is unique and will have its own set of procedures depending on the type of drug and the indication being treated.