By the Numbers Did you know… It takes, on average, 13 person years for the Food and Drug Administration (FDA) to review all the clinical studies (clinical trials) data for one new drug application for approval. That is the equivalent of 13 people working full time for a year doing nothing but reviewing clinical study data from a single application. Did you know… FDA spends two person years working with companies during the multi-year drug development program for each new drug. This involves reviewing data and the design of the critical clinical studies the company conducts. Did you know… It takes tens of thousands of pages of data and analysis to convey all the results from one clinical study. Did you know… • Phase I clinical studies generally only include between 30 and 100 participants to evaluate safety, determine a safe dosage range, and identify potential side effects of an investigational medicine. • Phase II clinical studies only include between 50 and 300 participants to see if a medicine shows some evidence of effectiveness and to further evaluate its safety. • Phase III clinical studies include a larger group of participants — on average 3,000 but as many as 10,000 — to confirm its effectiveness, monitor side effects, and collect information that will allow the drug to be used safely. • Phase IV clinical studies consist of post-marketing studies to delineate additional information including the drug's risks, benefits and optimal use. Did you know… In 2002, more than 71,000 people in the United States worked directly in the clinical- study process in the search for cures to new and existing diseases. Did you know… It takes seven to eight years to complete phase I through phase III of the clinical study process. Did you know… Of the 250 drugs that enter preclinical (animal) testing, only five enter clinical testing, and only one gets final approval from the FDA. Did you know… Many clinical studies are underway today searching for cures for: • Cancer – 402 (almost a 50% increase in seven years; 215 was the previous number) • Heart disease and stroke – 123 (20% increase in four years) • HIV/AIDS - 83 • Neurological diseases – 176 • Older Americans – 780 • Children – 200 • Diabetes – 23 • Asthma – 13 • Osteoporosis – 15 • Infectious Diseases – 185 • Women – 371 • Hispanic-Americans – 258 • African-Americans – 249