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

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 cha...