The Research Process: Phase I – IV Clinical Trials
The primary purpose of the Phase I clinical trial is to evaluate what is the most effective plan of care and/or dosage of a drug for use in the treatment of a patient with a particular disease (such as diabetes) or medical disorder.
In a Phase II trial, a slightly larger group of patients with already existing or potential health problems is studied for a longer period of time to determine the safety and effectiveness of the investigational medication in the treatment or prevention of disease.
Phase III studies involve a large number of participants, and usually compares a standard FDA-approved medication to a new drug that is currently in the FDA-approval process.
The Phase IV clinical trial begins once a pharmaceutical or medical treatment has been approved for marketing to the public. This expanded study explores the effectiveness of a drug or treatment protocol over an extended period of time for any side effects with its long-term use.
Who Can Participate In A Clinical Trial?
All clinical trials have specific guidelines detailing who can participate in the program. These parameters include such factors as age, type of disease, medical history and current medications that the individual is taking. Before enrolling in any study, you must be qualified based on the study’s guidelines. Our medical coordinator will help answer any additional questions you may have regarding whether or not you are qualified to participate in one of our current or future study trials.
What Happens During A Clinical Trial?
The specific trial process is dependent upon the type of study undertaken. Throughout the investigative process, a team of health professionals will monitor your participation, carefully evaluating your progress during the study. We will remain in contact with you following your completion of the program.
Interested in Participating in a Clinical Research Trial?
Participants in clinical studies can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Contact our West Palm Beach office today to learn more.