Every Florida orthopedic clinical trial has guidelines about who can participate. Some studies seek participants with specific illnesses or conditions to be researched in the clinical trial, while others may need healthy participants for comparison purposes. The guidelines that help to produce reliable results from these studies are called inclusion and exclusion criteria, respectively.
Inclusion criteria identify whether a clinical subject can be included in a clinical trial. The person may be required to be healthy, or suffering from the medical condition that the trial drug or treatment is designed to help. By comparison, exclusion criteria establish who will not be able to participate in the trial. For example, certain drugs can affect people who drink, smoke or exercise more than the average person, therefore individuals with these factors would become ineligible for the study. Inclusion/exclusion criteria may include the following:
• Age of the participant. Most studies require a minimum age of 18 years old.
• Gender and/or race. Certain studies may focus on members of one gender or race.
• Medical history. Factors such as the date of diagnosis of an illness, other therapies being used, and preexisting health conditions are important criteria.
• Type and stage of illness. Patients with very advanced illnesses will likely be excluded.
• Activity level. How active the participants are in their day-to-day routines may influence a study’s outcome.
Remember, the purpose of inclusion and exclusion criteria is not to judge or reject people personally. Instead, these guidelines identify appropriate participants, keep them safe, and ensure that researchers will be able to answer the questions they plan to study. Inclusion/exclusion criteria should always be explained to each potential participant in a clinical research trial before they are enrolled in the study.
Located in the same facilities as Ft. Lauderdale Orthopaedics & Sports Medicine, Shrock Orthopedic Research draws study participants from all over South Florida who wish to participate in FDA-approved, cutting-edge orthopedic research. We are currently recruiting patients for several studies. For more information about our current studies or to become a research hero, please call (954) 400-5544 or email us at firstname.lastname@example.org.