New paradigm for drug developments—From emerging market statistical perspective

• Published in: Contemporary clinical trials Vol. 36; no. 2; pp. 697 - 703
• Main Authors: Quan, Hui, Chen, Xun, Zhang, Ji, Zhao, Peng-Liang
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2013
• Subjects: Biostatistics talent; Cardiovascular; China; Clinical trial; Data Interpretation, Statistical; Developing Countries; Drug Approval - methods; Drug Industry - manpower; Drug Industry - methods; Drug Industry - organization & administration; Health authority; Hematology, Oncology and Palliative Medicine; Humans; International Cooperation; PDUFA; Pharmaceutical industry; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - standards; China; Clinical trial; Biostatistics talent; PDUFA; Pharmaceutical industry; Health authority
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2013.06.009

Abstract Paradigm for new drug development has changed dramatically over the last decade. Even though new technology increases efficiency in many aspects, partially due to much more stringent regulatory requirements, it actually now takes longer and costs more to develop a new drug. To deal with challenge, some initiatives are taken by the pharmaceutical industry. These initiatives include exploring emerging markets, conducting global trials and building research and development centers in emerging markets to curb spending. It is particularly the current trend that major pharmaceutical companies offshore a part of their biostatistical support to China. In this paper, we first discuss the skill set for trial statisticians in the new era. We then elaborate on some of the approaches for acquiring statistical talent and capacity in general, particularly in emerging markets. We also make some recommendations on the use of the PDUFA strategy and collaborations among industry, health authority and academia from emerging market statistical perspective.