文档介绍：Clinical Cancer Research
Theresa Higgins
Cancer Center
Beth Israel Deaconess Medical Center Boston, MA
Drugs through Pipeline (From Birth to Market)
How long does it take a drug to get to market?
Timeline for Drug Development
Preclinical Research
At Least 5 Years
File “Investigational New Drug” Application with FDA
Clinical Studies
7 Years
Phase I
Years
Phase II
2 Years
Phase III
Years
File “New Drug Application” with FDA
Review by FDA
PostmarketingSurveillance
Approval
Years
Ongoing
Preclinical Research
At Least 5 Years
Discovery and early screening pound
Large-scale synthesis
Animal Testing
File Investigational New Drug (IND) Application with FDA
Investigational New Drug
A new drug, antibiotic drug, or biological drug that is used in a clinical investigation
A biological product used in vitro (test tube or artificial environment) for diagnostic purposes
Phase I: Screening for Safety
10-100 people, typically healthy
Seeking to learn maximum safe dose of drug
Length: yrs
Cost: $10 Million
Phase II: Establishing Protocol
50-500 patients with the disease being studied
Define experimental conditions that will allow Phase III to give a definitive result
Find the efficacy of treatment in the disease being studied.
Length: 2 yrs
Cost: $20 Million +
Phase III: The Final Test
300-30,000 or more patients with the disease being studied
Determine efficacy and tolerability relative to standard therapy.
Length: years
Cost: $45 Million
File “New Drug Application” with FDA
Application submitted by the manufacturer of a drug to the FDA for a license to market the drug for a specified indication
Review By FDA
Length: Years
Labeling
Phase IV Trials