PHASES OF CLINICAL TRIALS

 

OBJECTIVES OF THE DISCUSSION:  By the end of this discussion, the learner/medical student will be able to;

1.  List the intentions of phase 1 clinical trials

2.  Continue with the description of following clinical phases

PHASE 1: Safety and dosage: In some of my previous discussions I was talking about a drug being able to cure the intended disease but also have minimal side effects or in simple terms, safer for the patient.  Phase I trials are the first tests of a drug with a lesser number of healthy human volunteers. In most cases, 20 to 80 healthy volunteers with the disease or a condition participate in Phase 1. Patients are generally only used if the mechanism of action of a drug also known as pharmacodynamics, indicates that it will not be tolerated in healthy people. Pharmacodynamics

However, if a new drug is proposed for use in Parkinsonism patients lets say, researchers conduct Phase 1 trials in patients with that Parkinson’s disease. Phase 1 studies are closely monitored and collect information about Pharmacodynamics in the human body.

Researchers adjust dosage regimen based on animal study data to find out what dose of a drug can tolerate the body and what are its acute side effects. As a Phase 1 trial continues, researchers find out research mechanism of action, the side effects accompanying with increase in dosage, and information about effectiveness. This is imperative to the design of Phase 2 studies. Almost 70% of drugs travel to the next phase.

RELATED;

1.  CLINICAL TRIALS PHASE 2  

2.  CLINICAL TRIALS PHASE 3  

3.  CLINICAL TRIALS PHASE 4  

4.  EXPERIMENTAL STUDY DESIGNS

5.  EXPERIMENTAL STUDY DESIGNS

REFERENCES