An in-depth analysis of Phase 3 and 4 clinical trials:
Phase 3 and 4 clinical trials:
As you can imagine, clinical trials must be conducted before an entity can obtain the necessary authorizations to bring its products to market. Therefore, clinical trials are a fundamental and systematic step in the development of a drug or a product intended to replace an existing treatment.
Before reaching the clinical trial stage, a multitude of preclinical development steps must be completed, and only then can a company hope to begin patient trials. These trials have several critical roles, including focusing on treatment effects and judging its effectiveness.
Phase 1 and 2:
Phase 1 clinical trials consist of estimating the habituation to a drug, establishing the different doses to be administered and detecting possible side effects.
Phase 2 clinical trials are conducted on patients with the necessary conditions to advance the study. In addition, they aim to accurately determine the efficacy and safety of the drug. Click here to learn more
Phase 3 and 4 of a clinical trial on patients:
Phase 3 clinical trials are conducted on a large sample of people from the patient population for which the treatment is intended. In phase 3, the objective of the trials is to compare the drug being tested and evaluate its properties to judge its effectiveness compared to the drug already on the market or to a placebo.
Phase 4 trials are undertaken after the drug is marketed. It is intended to be tested on a larger number of people and in a context of real use. Phase 4 therefore makes it possible to evaluate its efficacy, tolerance and any (rare) side effects that were not highlighted in phase 1, 2 and 3.
The table below is a summary of the different phases of a clinical trial :
Nevertheless, it is essential to know that more than half of the phase 3 studies concerning new drugs fail. This failure is notably linked to a lack of efficacy or obvious safety problems. To this effect , a study by JAMA internal Medecine shows that out of 640 drugs in phase 3, only 46% succeed. However, it should also be noted that some failures can also be linked to purely commercial or strategic reasons.
Are you interested in participating in a clinical trial? Do you have questions about clinical trials?
We invite you to contact us : info@gengepartners.com