What are the medical benefits of the clinical trial?
The clinical trial is also known as clinical research conduct these clinical trial in Miami Florida research center on humans by the approval of health authority or the ethics committee of the country where these clinical trial process will be comprehensive. As these authorities are the responsible for the ratio of risk or benefit factor, therefore, they gave the authority for the therapy of clinical trial that not means the therapy is successful or effective the benefit /risk ratio only depends on the outcome from the clinical trial conducted.
The goal of the clinical trial in Miami Florida is to be designed to ensure the scientific validity or reproducibility of the result. These clinical trial depend on the product or the stage of development firstly investigator start the small study on the human participant after the progress of the development stage they applied the large scale of research as per the studies. This clinical trial differs in size and cost of these trial may involve single or the multiple research center and it’s possible these trial has to be done in one country or may be used multiple countries and the cost of these trial based on the cost per drug sponsor by the government organizational, pharmaceutical, biotechnology and medicine company and the functions of these trial monitoring on the lab, managed by outsource partner such as central laboratories or contract research organization.
Here new drugs of the clinical trial are classified into five phases.
Phase 0: This phase is the optional trial first in humans or not. The single dose of study drug is given to the small number of people (10-15) the outcome what the drug does to the body “pharmacodynamics” and what the body does to the drug “pharmacokinetics”.
Phase 1: These phase for screening the safety or identify the side effects given to the safe dose of the drug for the small group of people (20-80) to test for the side effect is suitable or long-term or maybe these effects only for few peoples.
Phase 2: This phase also testing for the safety or side effects so given to the safe dose of the drug allows to a large number of people (100-300) as of trial phase 1 is clear.
Phase3: This is the final phase of confirmation of safety and efficiency so the given drug to the large group of people (1000-3000) to monitor the side effects and confirm the efficiency after that the data will allow it to be used safely.
Phase4: In this phase, the clinical trial drug is safe for the treatment risk, benefit, and optimal use.