What is a Clinical Trial?
Promoting Health Through Comprehensive Research
Any pharmaceutical agents whether over-the-counter (OTC) or prescription must be tested to ensure that it is safe for human consumption and also treats, ameliorates or cures a medical condition that the agent is indicated for and does not pose a significant risk of harming those who take the agent. New medications which are in the “pre-clinical” stage are usually tested on animals. Once it is determined safe in animals, the medication enters the “clinical trial” stage.
Clinical Trials are overseen by the Food and Drug Administration (FDA) which ensures the safety and efficacy of the investigational drug and an Institutional Review Board (IRB) which ensures that the rights of research subjects are protected.
Those who are interested in participating in a particular clinical research study must meet certain, very specific criteria. Not all prospective study volunteers will be the criteria to participate in the study and it is the job of the Principal Investigator and the clinical research team to screen all prospective study participants and determine in they are eligible according to the study protocol.
Once a prospective study volunteer meets the stringent criteria to participate in a clinical research study, they go through a process called “Informed Consent” where the study volunteer is explained what the clinical trial they are interested in participating is all about, what they are going to encounter and receive in the clinical study as well as the possible risks and benefits of study participation. Study Participants are required to attend numerous study related visits where the participants will receive study related medical examinations, diagnostic testing, questionnaires, lab work, study related medications and more. Participation in a clinical study is completely voluntary and participants are informed of and made aware of the procedures they will be asked to complete prior to entering the study. Study participants are compensated for their time and travel in return for their participation.