Phases of Clinical Trials:
When clinical research is used to evaluate the medications and medicinal devices, Clinical trials are kind of clinical research design to evaluate and test new interventions such as psychotherapy or medications.
Types of Clinical Trial Phases:
Phase I - safety and safe dose range (Tolerance determination)
Phase II- Safety and Efficacy
Phase III- Safety, Efficacy and Toxicity
Phase IV- Post market surveillance
Types of Clinical Research:
Treatment research generally involves intervention such as psychotherapy, medications, new medicinal devices, new approaches to sergery or radiation therapy.
Prevention research looks for better ways to prevent disorders from developing and returning. Different types of prevention main study medicines, vitamins, vaccines, minerals or lifestyle changes.
Diagnostic research refers to practice of looking for better to identify a particular disorder or condition .
Screening research aims to find best way to detect specific disorder or health condition
Let's explain in short each clinical phase:
Phase I: in this phase of clinical study small group (10 subjects) of healthy volunteers will be used for determination of safety and the dose range for new drugs for development.
Phase II: in this phase of clinical study small group (50-100) of patients will be used for determination of safety and efficacy for new drugs for development which will be used for specific disease or disorder.
Phase III: in this phase of clinical study more patients (300-1000) will be used for determination of safety and efficacy and Toxicity levels (adverse side effects) for new drugs for development which will be used for specific disease or disorder.
Phase IV: Find more information about long-term side effects.
In Phase IV trials, doctors study treatments that the FDA has already approved. The goal of Phase IV trials is to continue studying side effects of a new treatment.
Clinical research
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