Guide to 4 Clinical Trial Phases/Stages

There are a series of steps involved in a clinical trial. Each stage is designed for answering different questions related to the research. In this blog, we have explained the four stages of a clinical trial.

Phase 1

In the first phase, researchers test a new treatment or drug on small groups of people. It is meant for evaluating the safety of the drug and to determine a safe dosage range along with identification of side effects.

Phase 2

In this clinical trial phase, interventions are studied on a larger group of people for determining the efficacy. This stage is also meant for evaluating the safety of the drug or treatment further.

Phase 3

This stage is meant for studying the efficacy of a drug or treatment in large groups of participants. It is done by comparing the drug to other standard drugs. Phase 3 studies are used for monitoring the adverse effects and for collecting information that allow the safe use of the drug or treatment being studied.

Phase 4

The fourth phase is conducted after the drug has been marketed. It is designed for monitoring the effectiveness of the approved intervention in the general population. In the fourth phase, information is also collected about its adverse effects related to its widespread use. The collected information can also be used for investigating the potential use of the drug or treatment in a different condition with other types of therapies.

Pharmacovigilance services are also important in clinical research studies. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects of the drug or treatment. It plays an important role in ensuring that doctors have sufficient information for making a decision as far as choosing a drug for treatment is concerned.