The 4 Clinical Research Phases

Students

May 18

Clinical researches are carried out in four phases to ensure consistency and accuracy.

Let's go through the four phases of clinical research.

Phase 1: Phase 1 starts with the first clinical trials performed on people. This phase immediately follows the preclinical research assessment of tests and treatments on animals. This shows how a drug is processed in the human body and its effects. A very small dose is administered to a group of 10 - 15 people. To learn more about the roles and responsibilities during this initial phase, consider enrolling in the Clinical Trials Assistant Training course.
Phase 2: This phase is tested out on a larger, yet still small group of 15 - 30 people. Low doses are given before they are increased till side effects become too severe or the desired effect is seen. Phase 2 tests the safety of the drugs before it can be moved to the next phase. For those interested in further exploring drug safety and its monitoring, the Pharmacovigilance Certification might be of interest.
Phase 3: This phase further assesses the safety and effectiveness of the drug. This time it is administered to 100 - 300 patients. New combination of treatment and drugs are tested and if found to effective, the new drugs are compared to the standard of care drug. They are compared to ascertain which drug works better. The trials are randomized. Patients are randomly placed into groups and tested with different treatments. This phase is quite important as it helps and provides the necessary information needed for the FDA to approve the new drug to be used in the general public. Aspiring Clinical Research Coordinators can deepen their understanding by taking the Clinical Research Coordinator course.
Phase 4: This final phase tests the newly FDA approved the drug in several hundred or thousands of patients. This enables better research and identification of short-lived and long-lasting side effects of the drugs. For professionals interested in leading clinical trials, the Advanced Clinical Research Project Manager Certification offers extensive training.

Generally, Phase 1 is the earliest phase of clinical research, but sometimes clinical researchers or clinical professionals might need you to join a phase 0 study. Phase 0 studies are aimed at finding out if a drug behaves the way it did in the laboratory studies. Phase 0 studies involve a small number of people (10 - 20) who are given a very small dose of the drug. The dose of the drug is so little that the chances of having any side effects are of the most minimal.

All these phrases are performed by clinical research scientists. They perform medical research for the main purpose of improving human health. They design studies on the investigation of particular diseases, the development of the medical device, and the evaluation of a drug's safety or effectiveness. They are also responsible for getting the funding for their experiments by periodically writing for grants and proposals for submission to governmental agencies and private organizations. Clinical research scientist can work anywhere, be it in the university, private organizations, hospitals, and research institutions. For physicians aiming to become principal investigators, the Advanced Principal Investigator Physician Certification and for those looking to specialize in medical monitoring, the Medical Monitor Certification are valuable resources.

Take courses from CCRPS and learn more on how to become a clinical research professional.

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