The Phases of Clinical Trials

Once a drug has been approved for human testing by the FDA, volunteers are asked to participate in a clinical trial. To ensure compliance, some drug makers offer monetary incentives to participants. If you are considering participating in a clinical trial, it is important you understand how they work. Below, we outline the major phases of clinical trials:

Phase I

This first round of testing generally lasts for months. A small group of healthy volunteers is given the drug and they are tested to see its impact on their bodies. The absorption rate, how the drug is metabolized, and how it is excreted. Side effects are also monitored for varying dosages.

Phase II

This phase tests the efficacy of the drug. It lasts for up to 2 years and involves more volunteers than in the previous phase. During phase II, a set of volunteers are given the real drug and others, a placebo. Data from this phase is used to show how safe and effective the drug is. About 33% of drugs pass phase I and II.

Phase III

Phase III involves blind testing; where even the researchers do not know which participants have the real drug or the placebo. It includes thousands of volunteers and can last for several years. It provides better information on the safety and effectiveness of the drug and up to 90% of phase III drugs pass the round.

Phase IV

This phase is conducted after the drug has already been approved for sale. The aim here is to compare the drug to similar ones in the market, track its effectiveness and how it affects quality of life, and determine how cost-effective it is in comparison to other therapies.

DM Clinical Research connects drug makers to volunteers looking to partake in clinical trials and advance healthcare and drug development. Contact us today to take part in one of our trials; call 281-517-0550 for any inquiries.

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