Clinical research phases


Clinical research phases: The steps taken before a new treatment is licensed.

Clinical Research Phases

What are the phases involved in clinical research?

Clinical research phases are the steps or stages taking during the testing of new drugs, medicines, or treatments, as well as the testing of old treatments in a new manner. They are divided into four different phases to test out the safety and effectiveness of a new treatment or the side effects of the new treatment. They also aim to test the effectiveness of the new treatment with that of existing ones.

There are 3 vital phases of clinical research, but some drugs start at a more earlier stage at Phase 0 and end up in Phase 4, which is the stage after a drug has been licensed.

Phase 0

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, which is aimed at finding out the behavioral abilities of a drug to see if it behaves the way it did from 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 barest minimal.

Basically, Phase 0 finds out whether the drug reaches cancer or affected cells, the cell's response to the drug, the effect of the drug in the body, and the response of the body to the drugs.

Phase 1

Phase 1 as said earlier, is the earliest phase of clinical research studies. They are often small trials given to few patients (20 - 80) with any type of advanced cancer but also those who already have other available treatments. Phase 1 finds out the doses and side effects, as this is quite important before testing the new treatment to see if it works.

Blood tests will be taken by clinical researchers to look at how the body copes with the drug and gets rid of the drug, as well as any side effects that happened during the use of the drug and after the use of the drug.

Basically, Phase 1 finds out the side effects of the drug, the dose that is safest to give, how the body copes and gets rid of the drugs, as well as if the treatment is effective in the shrinking of cancer cells.

Phase 2

Phase 2 is the make or break for all phase 1 drugs as not all of the drugs tested in Phase 1 go on to make Phase 2. Phase 2 research deals with larger sets of patients with the same or different types of cancer. Possibly 80 - 100 patients are tested upon most times with a placebo or a new treatment as opposed to the treatment already in use. The treatments can affect patients in different ways, which is why this phase is very important.

Basically, Phase 2 finds out if the new treatment is effective enough to go on to be tested in a phase 3 research that is larger than a phase 2, the types of cancer the treatment is effective for, the side effects of the new treatment and how best to manage it, and finally, the quantity of dose that is best to be administered.

Phase 3

Phase 3 deals with comparing new treatments with the standard treatments available currently. It involves dealing with a much larger set of patients numbering thousands from different hospitals, clinical sites, and countries.

Basically, Phase 3 finds out the treatment that works best for a particular type of cancer, the side effects of the drug, the treatments behavioral changes to the patient's quality of life, new ways of administering standard treatments, the comparison of the standard treatment to the new treatment, as well as the different doses of treatment that is appropriate.

Phase 4

Phase 4 is the final stage of all clinical trials as it wraps up all the trials done once the drug has been proven to be effective and has been licensed by the Food and Drug Administration (FDA).

This phase finds out more side effects of the drug, the safety of the drug, the effectiveness of the drug on a wider scale, and the long term benefits and risks of the new drugs, medicines, or treatments.

It's all a process of producing effective, competent, and safe drugs to the general public.

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

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