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SFBC International Inc. Data Table III

Table 3: FDA IND Drug Studies Conducted at SFBC International Inc., Miami and Approved by the Southern Institutional Review Board Inc. ( 1 )

Source: FDA Bioresearch Monitoring Information System (BMIS) File (current through 2005-09-30). U.S. Food and Drug Administration Division of Scientific Investigations. Available from (External) http://www.fda.gov/cder/foi/special/bmis/index.htm . Accessed 2005-11-15. An asterisk (*) indicates a blank field in the FDA Bioresearch Monitoring Information System (BMIS) File. The BMIS file includes information on drug studies conducted under FDA Investigational New Drug (IND) applications only. Bioequivalency studies conducted for generic drug marketing approvals are not included.

Key: FDA Bioresearch Monitoring Information System (BMIS) File fields

Table 4: Combined Data Part 1 – FDA IND Studies Conducted by SFBC International Inc. and Approved by the LeeCoast Research Center Institutional Review Board and Independent IRB Inc.

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Notes

1. There are 108 entries in Table 3. If you aren't familiar with databases it's helpful to think of an entry as one row of information in a table. The names of the columns (the first row in the table) correspond to the names of the database fields in the FDA Bioresearch Monitoring Information System (BMIS) File. Therefore a single row in Table 3 contains one piece of information for each field in the FDA Bioresearch Monitoring Information System (BMIS) File.

Most of the data for the entries in the FDA Bioresearch Monitoring Information System (BMIS) File come from Form FDA 1572, Statement of Investigator. Form FDA 1572 is available on the FDA web site at (External) http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.pdf

According to FDA regulations at 21 CFR 312.53(c), no investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator. The study sponsor in turn sends it to FDA. Source: U.S. Food and Drug Administration. 21 CFR 312 Investigational New Drug Applications. Available from (External) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312&showFR=1 . Accessed 2005-11-29.

When FDA receives a 1572, staff create two entries in the BMIS file database from each Form FDA 1572 : one for the investigator (indicated by DEM in the Type field), and one for the institutional review board (indicated by IRB in the Type field) identified in the Form FDA 1572. The date in Receipt Date field is date the source document (1572, etc.) was received by FDA. Source: FDA Bioresearch Monitoring Information System (BMIS) File. U.S. Food and Drug Administration Division of Scientific Investigations. Available from (External) http://www.fda.gov/cder/foi/special/bmis/index.htm . Accessed 2005-11-15.

The two entries from a single Form FDA 1572 have the same Receipt Date fields, so it's likely that each pair of entries in Table 3 of principal investigator and IRB with the same Receipt Date field represent an IND drug study conducted by SFBC International Inc. investigator Kenneth Lasseter M.D. and which was reviewed and approved by Southern Institutional Review Board Inc. Matching pairs of entries are highlighted in orange. The attributions are not, however, 100% certain. Because there are more than one (or many) entries in the FDA Bioresearch Monitoring Information System (BMIS) File with the same Receipt Date fields, only the investigator and sponsor (or institutional review board) know for certain which institutional review board reviewed and approved a specific study or who conducted it.

Southern Institutional Review Board Inc. is owned by Alison Shamblen, wife of E. Cooper Shamblen, former principal of Clinical Pharmacology Associates and currently vice president of clinical operations at SFBC International Inc. in Miami. Sources: SFBC International Inc. Management Team (Phase I/IIA Services) Miami. SFBC International Inc. web site. Available from (External) http://www.sfbci.com/sfbc/SFBC/client/en/AboutUs/Management.asp?id=7 . Florida Department of State, Florida Division of Corporations. Available from (External) http://www.sunbiz.org/corpweb/inquiry/search.html . Accessed on 2005-11-25.

It's often possible to rule out all other institutional review boards (because of jurisdiction etc.) and in the case of SFBC International Inc., since we know Southern Institutional Review Board Inc. reviewed and approved the vast majority of Dr. Lasseter's IND drug studies at the Clinical Pharmacology Associates site (where Dr. Lasseter formerly worked), it's reasonable to conclude this continued after SFBC International Inc. acquired Clinical Pharmacology Associates on 2003-08-13.

This information is intended to be read with the Bloomberg News story titled Big Pharma's shameful secret (With interviews and updates). David Evans, Michael Smith, and Liz Willen. Bloomberg News Special Report. 2005-11-08. Available from (External) http://www.bloomberg.com/specialreport/bigpharma.html , or in PDF from (External) http://www.bloomberg.com/specialreport/pharma.pdf . Accessibility verified 2006-03-28.

Last Updated: 2006-03-28

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