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About Us We are the Clinical Research Associates Connection (CRACONNECTION) In a nutshel, we attempt to help novice CRAs get around the catch 22 in clinical research as well as empower experienced CRAs to continue to pursue their dream career.

 

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Clinical Trials

Phase IV Clinical Trials: What's at Stake?

After phase III clinical trials, if you you thought drug development was complete, think again. Remember in phase 3, at least two big trials was conducted in order to get marketing approval. It is wise to say the drug is approved after phase III clinical trials, provided there was substantial evidence of safety and efficacy. Phase IV clinical trials is a "follow-up" of the drug in the general intented population. Let's talk about phase IV clinical trials. Are you ready?

home1 Phase IV Clinical Studies in a Nutshel: It's not Over!

Clinical trial phase IV is a means of trying out ways to improve the drug after marketing approval has already been granted. Maybe the sponsor is trying to come out with ways to improve dosage or new formulations or routes of administration. In this phase, researchers are also looking at and monitoring the drug's safety in the larger patient population. One reason these types of studies are conducted may be a means to fullfil requirement for marketing approval.

During a phase III clinical trials, the regulary body (FDA, for example) may request the drug sponsor perform phase IV studies, also called post marketing surveillance studies, on the drug as a condition for obtaining market approval for the drug. I think regardless of a requirement by regulatory bodies, a sponsor should always conduct phase IV trials if the sponsor is truly serious about assessing safety and efficacy of the drug. After all, the drug was tested in still a relatively small number of population even in phase III trials. What better ways to really get safety and efficacy data than in a more general and diverse population? Another reason a sponsor should always conduct phase IV trials is to add to or improve its product pipeline. The new drug might lead to studies for new treatment conditions. In phase IV trials, the sponsor also collect data to compare the newly approved drug with other drug therapies and products that are already on the market for the same indication. So, think of phase IV clinical studies as a very important step in the drug development process.

Photo courtesy of Rusland Clinical Research


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