Improving Pharmaceutical Innovation By Building A More Comprehensive Database On Drug Development And Use

被引:12
作者
Daniel, Gregory W. [1 ]
Caze, Alexis [2 ]
Romine, Morgan H. [3 ]
Audibert, Celine [4 ]
Leff, Jonathan S. [2 ,5 ]
McClellan, Mark B. [6 ]
机构
[1] Engelberg Ctr Hlth Care Reform Brookings, Evidence Dev & Innovat, Washington, DC 20036 USA
[2] Deerfield Inst, Epalinges, Switzerland
[3] Engelberg Ctr Hlth Care Reform Brookings, Washington, DC USA
[4] Deerfield Inst, European Market Res, Epalinges, Switzerland
[5] Deerfield Management, New York, NY USA
[6] Engelberg Ctr Hlth Care Reform Brookings, Hlth Care Innovat & Value Initiat, Washington, DC USA
关键词
RATES; DISCOVERY; FDA;
D O I
10.1377/hlthaff.2014.1019
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
New drugs and biologics have had a tremendous impact on the treatment of many diseases. However, available measures suggest that pharmaceutical innovation has remained relatively flat, despite substantial growth in research and development spending. We review recent literature on pharmaceutical innovation to identify limitations in measuring and assessing innovation, and we describe the framework and collaborative approach we are using to develop more comprehensive, publicly available metrics for innovation. Our research teams at the Brookings Institution and Deerfield Institute are collaborating with experts from multiple areas of drug development and regulatory review to identify and collect comprehensive data elements related to key development and regulatory characteristics for each new molecular entity approved over the past several decades in the United States and the European Union. Subsequent phases of our effort will add data on downstream product use and patient outcomes and will also include drugs that have failed or been abandoned in development. Such a database will enable researchers to better analyze the drivers of drug innovation, trends in the output of new medicines, and the effect of policy efforts designed to improve innovation.
引用
收藏
页码:319 / 327
页数:9
相关论文
共 17 条
[1]  
[Anonymous], 2012, REP PRES PROP INN DR
[2]   Industry funding of the FDA: Effects of PDUFA on approval times and withdrawal rates [J].
Berndt, ER ;
Gottschalk, AHB ;
Philipson, TJ ;
Strobeck, MW .
NATURE REVIEWS DRUG DISCOVERY, 2005, 4 (07) :545-554
[3]  
Citeline, 2015, CIT PHARM CLIN TRIAL
[4]   The price of innovation: new estimates of drug development costs [J].
DiMasi, JA ;
Hansen, RW ;
Grabowski, HG .
JOURNAL OF HEALTH ECONOMICS, 2003, 22 (02) :151-185
[5]   From HIV to Tuberculosis and Back Again: A Tale of Activism in 2 Pandemics [J].
Harrington, Mark .
CLINICAL INFECTIOUS DISEASES, 2010, 50 :S260-S266
[6]   Clinical development success rates for investigational drugs [J].
Hay, Michael ;
Thomas, David W. ;
Craighead, John L. ;
Economides, Celia ;
Rosenthal, Jesse .
NATURE BIOTECHNOLOGY, 2014, 32 (01) :40-51
[7]  
Herbst R., CLIN CANC R IN PRESS
[8]  
Infinata, 2014, BIOPHARM SOL SUIT
[9]   Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade, 2000-2009 [J].
Kaitin, K. I. ;
DiMasi, J. A. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2011, 89 (02) :183-188
[10]   The importance of new companies for drug discovery: origins of a decade of new drugs [J].
Kneller, Robert .
NATURE REVIEWS DRUG DISCOVERY, 2010, 9 (11) :867-882