A clinical research trial is a necessary step when pharmaceutical companies want to evaluate a new medication, device, or procedure. New medications, prescription or over the counter (OTC), must be tested thoroughly before being approved by the Federal Drug Administration (FDA). A clinical trial is designed to study the safety and effectiveness of a product, under the strict guidelines of the FDA.
Trials are conducted in four phases:
- Phase I is conducted on a small number (tens) of volunteers to test how the drug is absorbed, metabolized, and excreted in the human body.
- Phase II (few hundred) focus on how the drug compares to existing drugs or in general.
- Phase III (few thousand) continues to study the effectiveness of the drug over several years. After this phase, pharmaceuticals can submit the data to request FDA approval.
- Phase IV trials are conducted after the FDA has approved the medications for consumer sale. These studies focus on long-term effectiveness, cost effectiveness of the medicine, and can later be removed from the market, or safety warnings added to the labeling, based on study findings.
Each study follows a strict protocol that outlines who can participate, how much medication will be given, and how the effects will be measured. Each clinical trial is overseen by a Principal Investigator- a medical doctor trained in clinical research. At Urology Clinics of North Texas, all our Principal Investigators that work with us are Board Certified and have patients in their own practices.
People choose to participate in clinical research for a variety of reasons. Some people choose to participate to have access to new treatments if their current treatments are not working. Some people choose to participate to help advance medical knowledge. Participants also benefit from receiving a great level of medical care from diagnostic testing, free medications, and one-on-one physician consultations. Volunteers are also compensated for their travel and time, in the form of a stipend.
All volunteers are evaluated as part of a screening process, to determine study eligibility. Protocols have strict criteria as to who can be included in a study. The screening process may include: diagnostic testing, blood draws, questionnaires, vital signs, physical exams, etc. Participants are always given all the information they need to make a decision regarding a study and can choose to withdraw at any time. This is done through an informed consent process.
Before consenting to participate in a study, the FDA requires the patient to sign the Informed Consent document, stating that they understand the risks, expectations, time commitments, and compensations for a trial. An Informed Consent form is a step-by-step walk-through of everything that will happen over the course of the clinical trial. This is a one-on-one conversation where you may ask questions, and have anything that you are uncomfortable with explained. Before signing an Informed Consent document, make sure you feel fully informed about the study, and are willing to accept all the requirements. A participant can withdraw from a study at any time, but may not be fully compensated.
This process isn’t the only time to ask questions. Please feel free to keep asking questions. We are here to help you!
Your personal information is protected under HIPAA Privacy Rules, much in the same way as when you see your regular doctor. Researchers can obtain, create, and use your health information with your authorization, sharing it only with those involved in the clinical trial, and never disclosing enrollment in a study, or identifying participants in any reports of the research.
Texas Health Presbyterian Hospital of Dallas
(Formerly known as Presbyterian Hospital of Dallas)
Urology Clinics of North Texas Clinical Trials Office
8230 Walnut Hill Lane,
Professional Building 3,
Dallas, Texas 75231