Clinical Research for Patient Care Products

Clinical research that is related to developing products for patient care is divided into two preclinical and four clinical phases, each addressing different questions. The knowledge gained at each phase is assessed before progressing to the next. The table below provides an overview of the process. Click each phase to learn more.
 
More about the Preclinical Phase
More about the Phase I
More about Phase II
More about Phase III
 More about Phase IV
Average
Time/Study		 2 weeks to
2 years		 1 week to
1 month		 Several months
to 2 years		 Several months
to 4 years

Several months
to several years
Average#
of Subjects 		  20 to 100 Several 100 Several 100
to thousands 		50 to
thousands
Types of
Subjects		 Test tubes
and animals

Healthy
volunteers or
patients with
the disease.

 Patients
with the
disease		 Patients
with the
disease		 Patients
with the
disease
Main
Purpose		 Develop safety
parameters 		Determine
safe dose		 Determine
safety and
efficacy at different
dose ranges		 Determine safety
& effectiveness
in varied large
population		 Study drug
as prescribed
in general
population