A clinical trial is a research study that involves human volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. A clinical trial is used to determine if an investigational drug or therapy is both safe and effective. Clinical trials also determine new ways of using existing drugs or therapies. Clinical trials are carefully designed and monitored to ensure the safety of patient volunteers. Clinical trials are required by the Food and Drug Administration (FDA) before any medication can be used by the general public.
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Study coordinators and physicians closely monitor the participants throughout the study via physical exams, laboratory tests and other medical procedures. Often, these procedures are described as an extension of what is traditionally done to manage the patient’s health and medical condition. Patients in research studies receive study-medication, tests and exams at no charge throughout the course of the study. Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits.
Participant safety is the number one priority of any study.
Each study candidate is given an informed consent form to read. The Informed consent form describes in detail what is involved if you participate in the study. It describes the most common risks for the medication being studied and the potential benefits of participating in the study. You will be able to discuss the informed consent and ask questions prior to signing up for the study. The study staff and physician will help you fully understand the risks and benefits and your rights as a research participant. Participation in a clinical trial is voluntary. Your medical condition will be closely monitored throughout the study by experienced research staff and physicians. There are established safety parameters for each study. You may withdraw from the study at any time.