The Impact Of Globalization On The Statistical Services

Jorgen Seldrup was a discussant in a session on "The Impact of Globalization on the Statistical Services" at the ISBS/EMA/IBS-DR Joint Conference in Berlin on March 1, 2011.

"Some Considerations on Regional/Ethnic Differences and Similarities in Multiregional Clinical Trials"

• Japan: domestic (< E5/1998) Bridging (< MRCT-J/2007) MRCT
• 5 studies 'showing' regional differences (from PMDA Review Report) - "Not too convincing!"
• Differences: chance, PK, study specific ("combination?")
• Chance: Slide 22 (Marschner) Prob(≥ R have a treatment effect favouring the control arm) Region
• 2 ‘Japanese guidance' Sample size methods – "What is the basis?«
• PK (ADME); (obvious) candidates: Food, BM, genetics, clearence
• Study specific: population, prior Rx, medical environment, operational, etc
• How to avoid: Adjust for ‘relevant' factors, choose similar sites