What are Clinical Trials?
Clinical trials are voluntary research studies of human beings that are designed to answer specific health questions and necessary for the approval of new treatments.
Individuals volunteer to participate in clinical trials for a variety of reasons. Participation allows access to new treatments that are not available to the general public. Clinical trials are monitored very carefully, with additional testing with no additional cost. Finally, some volunteers take pleasure in helping others by contributing to medical research and potentially benefiting many patients with similar conditions in the future.
What is a Research Coordinator?
NCRVA Research Clinical Coordinators have extensive experience in coordinating clinical studies and would be the patient’s point of contact once your physician has established you as a potential subject. They help answer questions regarding the logistics of the study and coordinate your care. They are well versed with each study protocol to advocate for the safety and well-being of each participant.
What are the Phases in a Clinical Trial?
Phase 1 Trials: A small number of participants are used to test an investigational drug or treatment. The main focus is to determine the safety of the drug in humans. They evaluate the safe dose range and identify possible side effects from the drug/treatment.
Phase 2 Trials: After completing the Phase I trials, the information is used to treat a slightly larger limited number of participants. Phase II uses the information gathered from Phase I to further evaluate the safety and effectiveness of the drug/treatment.
Phase 3 Trials: The experimental treatment is given to a large group of participants in a variety of clinical settings to evaluate its safety, effectiveness and to monitor the side effects.
Phase 4 Trials: Once the drug has been approved by the FDA, this is when post marketing studies are conducted to continue to gain more information about the benefits and safety of the drug.