Clinical Research phases

Clinical researches are carried out in four phases, and it is only completed when there is enough reason to believe that new tests or treatments can improve the healthcare of patients.

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

  • Phase 1: This phase immediately follows the preclinical research assessment of tests and treatments. Preclinical research is always done on the animal to assess test, drugs, and treatments, and make sure that they are effective and safe. Phase 1 starts with the first clinical trials performed on people. This shows how a drug is processed in the human body and its effects on it. A very small dose is administered to a group of 10 - 15 people.

  • Phase 2: This phase is tested out on an increased, yet a small group of 15 - 30 people. Low doses are given before they are increased the dose by dose 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.

  • Phase 3: This phase further assesses the safety and effectiveness of the new drug. This time it is administered to 100 - 300 patients. It tests out new combination of treatment and drugs. If found to work, the new drugs are compared to the standard of care drug, they are both compared to ascertain which drug works better. This phase is randomized, patients are randomly placed into groups and tested with the treatments to see the results. This enforces the fact that the results are due to the treatment and not due to the group differences. 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.

  • Phase 4: This final phase tests the newly FDA approved the drug in several hundred or thousands of patients. This enables better research, with short-lived and longlasting side effects and safety of the drugs.

All these are performed by clinical research scientists. A Clinical Research Scientist performs medical research for the main purpose of improving health in animals or humans. They designed studies they involved investigation of particular diseases the development of the medical device and the evaluation of a drug's safety or effectiveness. they get 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.

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

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course


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