Improving protocol design feasibility to drive drug development economics and performance.
Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost of conducting less essential and unnecessary protocol procedures and of implementing amendments to protocol designs. Indirect costs including personnel time, work load and cycle time delays associated with complex protocol designs are also discussed. The author concludes with an overview of steps that research sponsors are taking to improve protocol design feasibility.
Center for the Study of Drug Development, School of Medicine, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA. Kenneth.Getz@tufts.edu.
Kenneth
K
Getz
D035843:Biomedical Research / Q000191:economics* / Q000379:methods*; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic; D006801:Humans