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HUMAN CLINICAL TRIALS
Human clinical trials are an important component of the research process. ans used most often in
developing prescription drugs. There are three major phases of clinical trials that begin after a
pharmaceutical firm files an IND or investigational new drug application with the FDA. The
IDN shows the results of laboratory testing and explains how the drug is made.
Phase I Researchers determine the drug’s interaction with the human system, including how it is
absorbed, distributed, metabolized and excreted as well as the duration of its effect. This phase
involves a SMALL number of health volunteers and takes approximately One Year
Phase II Uses controlled tests that help determine the drug’s effectiveness. these tests usually
involve 100-300 volunteers. Simultaneous animal and human tests are also conducted at this
stage. This phase takes approximately Two years
Phase III Trials are conducted to confirm the results of earlier tests and further identify any
adverse reactions. Clinical testing is extensive and involves 1,000-3,000 volunteer patients in
medical clinics and hospitals. This phase take s approximately Three years
After human clinical trials are completed, pharmaceutical firms file a NDA or New Drug
Application with the FDA. This is a comprehensive statement of information on: drug structure,
scientific rationale and purpose of the drug, pre-clinical animal and other laboratory study results,
all human clinical testing results, drug formulation and production details, and the company’s
proposed labeling. This takes approximately 2 ½ years
Currently it takes 12 years from initiation of animal and lab studies through all phases of
clinical trials and submission of data to the FDA for approval
FDA Approval
12 years
FDA Reviews (NDA filed)
2 ½ years
Clinical Studies
Phase Three Extensive Clinical Testing 3 years
100-3000
Clinical Studies
Phase Two Effectiveness
100-300
.
Clinical Studies
Phase One: Safety Studies
<100
L
Laboratory and
Animal Studies
2 years
1 year
3 ½ years