Role of the data monitoring Committee and sponsor in monitoring adaptive designs

American Pharmaceutical Outsourcing

Volumn 11, Issue 1, 2010, Pages 28-31

  Sashegyi, Andreas ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77955743753     PISSN: 15296318     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (8)

1. Gallo P and Krams M. PhRMA Working Group on Adaptive Designs: Introduction to the Full White Paper. Drug Information Journal 40(4), p.421-423 (2006).
2. Dragalin V. Adaptive Designs: Terminology and Classification. Drug Information Journal 40(4), p.425-436 (2006).
3. Quinlan J and Krams M. Implementing Adaptive Designs: Logistical and Operational Considerations. Drug Information Journal 40(4), p.437-444 (2006).
4. Gallo P. Confidentiality and Trial Integrity Issues for Adaptive Designs. Drug Information Journal 40(4), p.445-450 (2006).
5. Report on the EMEA-EFPIA Workshop on Adaptive Designs in Confirmatory Clinical Trials. http://www.emea.europa.eu/pdfs/ conferenceflyers/report_adaptivedesigns.pdf (2008).
6. Ellenberg S, Fleming T and DeMets D. Data Monitoring Committees in Clinical Trials: A Practical Perspective. Wiley, West Sussex, UK (2002).
7. CHMP Guideline on Data Monitoring Committees. http://www. emea.europa.eu/pdfs/human/ewp/587203en.pdf (2005).
8. FDA Guidance for Clinical Trial Sponsors: On the Establishment and Operation of Clinical Trial Data Monitoring Committees. http:// www.fda.gov/CBER/gdlns/clindatmon.htm (2002).