TABLE 2.
Investigative collaborations among academic investigators, epoetin manufacturers, and national regulatory authorities
| Principal investigators | French investigators: Casadevall, Rosert5 | Canadian investigators: Cournoyer, Messner18 | United States investigators: Bennett, Tallman, Nissenson6 |
|---|---|---|---|
| Date of first publication (number of PRCA patients) | February 14, 2002 (n = 13) | September 30, 2004 (n = 172) | September 30, 2004 (n = 191) |
| Primary collaborative work-group (funding source) | European PRCA Work Group (grants, Amgen, Johnson & Johnson) | Canadian PRCA Focus Group (Johnson & Johnson) | Research on Adverse Drug Events and Reports (grants) |
| Primary focus | Clinical, basic science | Epidemiology | Clinical, epidemiology |
| Participation in additional work groups (sponsor) | Ad Hoc Working Group for Diagnostic Criteria (Johnson & Johnson) | Ad Hoc Working Group for Diagnostic Criteria (Johnson & Johnson) | None |
| Participation in manufacturers’ advisory boards | Global Safety Advisory Board (Amgen), Immunology Advisory Board (Johnson & Johnson) | None | Global Safety Advisory Board (Amgen) |
| Primary data sources | Samples and clinical details sent from clinicians in England, France, Germany, and other European countries | Epoetin manufacturers data—worldwide experience | Epoetin manufacturers data and the FDA—worldwide experience |
| Countries where coinvestigators reside | France, Germany, United Kingdom, Italy | Canada | United States, Italy, Canada, France, Singapore |
| Presentation to regulatory authorities and manufacturers | 1999 | 2004 | 2004 |
| Collaboration with the other investigative groups | 2003 | 2004 | 2003 |