FAQ: What is a Clinical Trial?
What is a Clinical Trial?
A Clinical Trial (also called clinical study or clinical investigation) is a planned experiment designed to evaluate the efficacy of a treatment in humans by comparing the outcomes in a group of
subjects
treated with the test treatment (medications or medical devices) with those observed in a comparable group of
subjects
receiving a control treatment (no treatment, comparable treatment to the test group, better treatment than the test group).
Subjects
in both groups are enrolled, treated, and followed over the same period of time.
Clinical Trials also evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on research subjects and make determinations if they should be approved for the general public.
Why do we need volunteers to perform Clinical Trials? How do I benefit by becoming a volunteer?
Volunteers who engage in Clinical Trials can play an active role in the way they approach their own health, gain access to new research treatments before they are available to the public, and can potentially help other people by contributing to medical research.
Who can join a Clinical Trial?
All clinical trials have strict guidelines about who can participate. The guidelines 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 variables that include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a
subjects
must qualify for the study. It is important to understand that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate
subjects
and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
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