Clinical trials are research studies that involve testing new treatments or interventions on human subjects to evaluate their safety, efficacy, and effectiveness. These trials typically follow a structured protocol, or plan, that outlines the objectives, methods, and guidelines for the study. Clinical trials involve testing new drugs, medical devices, procedures, or behavioral interventions, and involve healthy volunteers and patients with specific medical conditions. The goal of a clinical trial is to determine whether a treatment is safe and effective in treating a specific disease or medical condition, and to gather data to support regulatory approval.

There are typically four phases of clinical trials:

Phase I: This is the first phase of clinical trials where a small group of healthy volunteers (usually less than 100) are given the new drug or treatment to test its safety, dosage, and potential side effects.

Phase II: In this phase, a larger group of patients (usually a few hundred) with specific disease condition are given the new drug or treatment to evaluate its safety and efficiency.

Phase III: In this phase, a larger group of patients (usually several hundred or even thousands) with specific disease condition are given the new treatment and are compared against a control group to evaluate its safety, efficiency, and potential side effects in a larger population.

Phase IV: This phase happens after the drug is approved by regulatory agencies and is available in the market. It involves monitoring the effectiveness and safety of the drug in a large number of patients over a long period of time.

Flow cytometry technology is one of the commonly used tests to monitor biomarkers and/or profile immune system during a clinical trial. Flow cytometry-based assays are used at all stages of the drug development process, preclinical to Phase III. The advantage of using flow cytometry method is the ability to use multiparameter analysis allowing simultaneous detection of several functional characteristics of a cell. Flow cytometry is utilized in clinical trials to monitor changes in immune cell phenotype, and to monitor therapeutic cells (e.g., CART cells) and abnormal or cancerous cells in blood and/or bone marrow aspirate.

This presentation will detail the Phases of clinical trial and discuss one of the technologies used to monitor cellular biomarkers during all Phases of the clinical trial.