Clinical research phases

Phases of clinical trials

Clinical trials, particularly related to pharmaceutical research, is essential to the process of drug development. Since the development of a new drug involves several steps, this process usually is segmented into four phases. You should know that clinical trials are aimed at two types of volunteers: Volunteers that are sick and healthy volunteers, allowing them to create a control group that has no diseases that could influence the results of the clinical trial. Studies of phases 2 to 4 (II, III and IV) are devoted solely to volunteers with a disease or disorder related to the study referred to.

Drugs on the market have all been the subject of clinical trials, even aspirin!

Phase 1 : The first phase of a clinical trial aims to test the safety of the new drug. Phase I studies are aimed at healthy volunteers, usually based on a small number of participants and the new drug is administered at low doses.

Phase 2 : The second phase of a clinical trial is to assess more thoroughly the safety of new drug and its effectiveness. This phase usually involves several hundred volunteers with the target disease.

Phase 3 : The third phase of a clinical trial is designed to validate the effectiveness of the new drug. This phase also includes determining its adverse effects. Phase 3 trials may involve the participation of 1,000 or more subjects. We do the randomization into 2 groups: new drug and reference drug (or placebo). If we get significant results, we can proceed with the drafting of an application for marketing.

Phase 4 : The fourth and final phase of a clinical trial is an oversight. This is when the business use of the new drug is approved by health agencies and regulators. It is also at this stage that other information is collected about the risks and benefits of the drug and the best manuals. Also called "post-marketing or post-marketing" because the drug is usually already on the market.