Phases of Clinical Drug Trials

Doctor holding medical injection syringe

Before drugs are sold to the public, they first undergo a number of processes to determine their effectiveness. One of these is tests involving humans, which are known as clinical trials.

Clinilabs, Inc. explains the goals of these trials are to determine whether the drug works, how effective it is, and how humans respond to it, among others. Drug trials generally come in phases 1, 2 and 3, but some tests also include phase 0 and 4. Knowing the phases of clinical trials can help you understand how drugs are evaluated.

Phase 0

Phase 0 serves as the first step in some drug trials to determine whether the drug will work. A low dosage of the drug is used in a small number of people to see how their bodies respond. In most cases, people who volunteer to be part of phase 0 testings will not experience any significant changes and benefits, as the drugs are administered in small amounts.

Phase 1

This phase aims to determine whether the treatment is safe. This phase allows researchers to know the right amount of dosage, the side effects of the drugs as well as the body’s reaction to it. Like Phase 0, volunteers for Phase 1 are not a lot and therefore, rare side effects might not be discovered until later.

Phase 2

Phase 2 further determines the effectiveness of the drug. A larger group of patients is tested, usually ranging from 25 to 100. The goal of this phase is to determine how well the drug works and whether or not it can proceed to the next trial phase.

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Phase 3

This phase aims to compare the new drug and the standard treatment. Therefore, the number of patients tested is larger than the previous phases to see the effects better. This phase determines whether the public can safely use the drug.

Phase 4

Once the drug has a license and is shown to work, Phase 4 is carried out to further determine possible side effects, long-term risks, and benefits, as well as the effects of the drug if it is used on a wider scale.

Drug testing is an important part of the search for cure for conditions like cancer, diabetes, and Alzheimer’s disease, among others. Thus, the success of every phase is imperative for future patients.