Event Information

Time：August 22, 2014 (Friday) 03:00-05:00 p.m.

Place：TRPMA Conference Room
（1F, No. 465-1, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei City 11557, Taiwan）

The TRPMA invited Dr Chen Chwen-Cheng of the US Pfizer Inc. to give a special talk on the interim analysis. Dr Chen explained the objectives, methodology and data interpretation from a scientific viewpoint. Dr Chen also shared his experiences of applying interim analysis to drug R&D.

Interim analysis is a common clinical trial design for drug development. According to international manufacturers’ experiences, the efficacy interim analysis has three major purposes: 1) to get preliminary information on the effectiveness of a drug so as to expedite the drug review process under special circumstances, such as severe diseases, unmet medical needs, etc.; 2) to terminate clinical trials earlier than scheduled so as to reduce unnecessary research spending if finding suggests unsatisfactory efficacy; 3) to use interim analysis results as reference for planning follow-up clinical trials and next stage drug development policy.

Generally speaking, there are three types of interim analysis results: 1) to continue as planned; 2) to modify protocol; and 3) to terminate trials. The decision of terminating a clinical trial could be based on the lack of robust efficacy, futility or safety issues.

Dr Chen incorporated news events into his talk, arousing a lively discussion with the audience. Refreshments and beers were served by the TRPMA after the talk to encourage the exchange of comments in a relaxed atmosphere.

The TRPMA invited Dr Chen Chwen-Cheng of the US Pfizer Inc. to give a special talk on the objectives, methodology and interpretation of interim analysis.