Innovative approaches in drug development.
This is the white paper on Innovative Approaches in Drug Development developed by the Biotechnology Industry Organization's (BIO) Clinical Trial Designs Workgroup. As recognized by the Food and Drug Administration's Critical Path Opportunities Report, the need to develop and apply innovative approaches to create new trial designs and clinical development programs is rapidly on the rise. Such novel approaches hold tremendous potential in the ability to refine mechanisms lying at the fundamental core of product safety and efficacy. The paper addresses the opportunities, challenges in pre-clinical and clinical trial design innovations; emphasizes the importance of safety database; and makes recommendations for carrying out the innovative approaches. The views expressed here in are solely those of the authors and do not reflect the official views of the Biotechnology Industry Organization.
Chang
Mark
M
Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts 02139, USA. mchang@mpi.com
Kenley
Susan
S
Bull
Jonca
J
Chiu
Yuan-Yuan
YY
Wang
Wenjin
W
Wakeford
Charles
C
McCarthy
Katherine
K
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data / Q000639:trends*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003627:Data Interpretation, Statistical; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D023381:Endpoint Determination; D006801:Humans; D010601:Pharmacology, Clinical / Q000639:trends*; D012107:Research Design / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration