Clinical Development of Therapeutic Medicines: A Biopharmaceutical Versus Pharmaceutical Product Comparison

Abstract

The clinical development of therapeutic medicines is a time-consuming and resource intensive process. The published literature documents the length of clinical phases, but there are few published reports on the number of clinical studies and the number of human subjects involved in the development of therapeutic medicines. In this Tufts Center for the Study of Drug Development investigation, clinical study data for 12 new biophar-maceutical products approved in 1994 through 2000 were analyzed and compared to the results of published clinical study data for new molecular entities (NMEs) and new active substances (NASs) approved during the same time period. We found that, on average, development of the biopharmaceuticals involved significantly fewer studies per application compared with the studies of NASs (11.8 studies vs. 37 studies) and also fewer subjects per application compared with the studies of either NMEs or NASs (1014 subjects vs. 5697 subjects for NMEs approved in 1998, 4980 subjects for NMEs approved in 1999, or 4478 subjects for NASs). A possible reason for this finding is that many of the biopharmaceuticals included in the analysis were treatments for diseases that affect a potentially small number of subjects, that is, rare, serious, or life-threatening diseases.