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Biotech / Medical : COMPUTERIZED THERMAL IMAGING (COII)- research only -- Ignore unavailable to you. Want to Upgrade?

To: chirodoc who wrote (88)	3/2/1999 9:44:00 AM
From: chirodoc	Respond to of 256

how many scans needed for FDA It is my understanding that for the FDA submittal they need a total of 600 patients which include 300 benign and 300 cancerous lesions. Since mammography has a 75% to 80% false postive rate, the 300 benign lesions will be reached very quickly. For the trials to see 300 malignant lestions they will have to examine approproximately 1500 patients (300/20%). Since COII is also, as they said, monitoring the process of this blind study by taking some samples seperate from the blind study, it is not surprising to hear that they need to study the results from 2000 to 3000 patients. If they were not montitoring the study themselves then 1500 to 2000 patients should be more than enough to get 300 benign and 300 malignant lesions. Jim