And the patient enrollment phase of a trial is the most variable part of the process-that is, the spot where we could most reasonably expect to drive down costs.

Add in the costs of per-patient medical procedures, drug supplies, laboratory work, and sponsor’s personnel, and a median-sized clinical trial can cost upwards of $25 million, about $36,000 every single day.Ĭlearly clinical trials are extremely important to the pharmaceutical industry both as the source for clinical data and as an enormous cost center. Nowadays a single clinical trial can be capital intensive (up to $500 million), with massive geographic coverage (as many as 53 countries), long duration (five years or longer), and enroll a large number of patients (20,000- to 50,000-patient trials are no longer rare).Ī median Phase III clinical trial involves about 800 patients, 50 investigator sites, and two years (700 days) from First Subject First Visit (FSFV) to Last Subject Last Visit (LSLV). Nothing in any other industry quite compares to the pharmaceutical industry’s clinical development process.In 2007, $28 billion dollars were spent on drug development.

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