Phase 3 Clinical Trials

Clinical trials are extensive tests performed in the world of medicine for the purpose of ensuring safety and efficacy before a certain drug, device, therapy protocols or diagnostics is brought up, used, and officially cascaded. Clinical trials are “sets of tests in medical research and drug development that generate safety and efficacy data for health interventions”.

An extensive process is being conducted to meet the requirements or needed development to prove that a drug or any device to be utilized for the sake of treatment of diseases will help the patient. There are different phases in the process of clinical trials.

  1. Pre-Clinical Trial (Theory): This is the formation of hypothesis and is considered a pre-clinical trial.
  2. Phase 1 (Modeling): This is phase 1 before bringing a pharmaceutical product to market where underlying mechanisms need to be identified and how the product can be developed or modified by an intervention.
  3. Phase 2 (Exploratory Trial): This is the first design for an intervention that is replicable. This trial applies protocol to compare alternatives and redo them to refine dosages, etc. This is Phase 2 of the clinical trial process.
  4. Phase 3 (Definitive Trial). This is where trials are being conducted mainly to make comparisons. This is Phase 3 of the clinical trial process. See below for more information on what happens in Phase 3 of a clinical trial.
  5. Phase 4 (Long Term Implementation): This is the last phase of the clinical trial process where it is essential to monitor routine or repetitive application of therapy by others. Collecting date to ensure safety is also part of this phase.

The phases outlined above are stages to find ample evidence for a process that would be useful as a medical treatment.

What Happens in Phase 3?

Phase 3 clinical trials are the most expensive and time-consuming. They are designed to assess how effective the new intervention is and its value to clinical practice.

Phase 3 studies typically involve a large group of patients, depending upon the medical condition being studied. This phase focuses on how effective the drug is compared with the current standard treatment. Aside from the fact that it is the most expensive and time consuming due to the size and comparatively long duration of study, trials conducted are complex especially in the area of therapies for chronic diseases or medical conditions.

A short follow-up period for assessment is done for Phase 3 trials of chronic conditions or diseases that are comparative to the duration of time the intervention may be used in practice. Phase 3 clinical trials are also sometimes refered to as the “pre-marketing phase” since it essentially measures the response of consumers to the drug.