Publication Library & Research Findings

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Research Article
Obstacles and Opportunities in New Drug Development
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
12/19/2007
Impact Report
Notable Gender & Racial Disparities Exist Among Clinical Investigators
November/December 2007
Commentary
Should the Patent System for New Medicines Be Abolished?
Clinical Pharmacology & Therapeutics
Joseph DiMasi
9/26/2007
Research Article
Global Clinical Trials Activity in the Details
Applied Clinical Trials
Kenneth Getz
9/1/2007
Impact Report
Despite More Cancer Drugs in R&D, Overall US Approval Rate is 8%
September/October 2007
Research Article
The Cost of Biopharmaceutical R&D: Is Biotech Different?
Managerial and Decision Economics
Joseph DiMasi
8/17/2007
Impact Report
Follow-On Drugs and Indications Play Key Role for World Health Organization
July/August 2007
Commentary
Commentary [on Scherer (2007), Berndt et al (2007), and Reiffen and Ward (2007)]
Managerial and Decision Economics
Joseph DiMasi
6/1/2007
Commentary
Mandatory Comparator Trials for Therapeutically Similar Drugs: An Assessment of the Facts
American Journal of Therapeutics
Kenneth Kaitin, Joseph DiMasi
5/1/2007
Research Article
CRO Shifts in the Outsourcing Market
Applied Clinical Trials
Kenneth Getz
5/1/2007
Impact Report
Challenges Loom For Postmarketing Study Commitments; Benefits Unclear
May/June 2007
Research Article
Determining the Costs of Institutional Review Boards
IRB: Ethics & Human Research
Kenneth Getz
3/1/2007
Impact Report
Pediatric Study Costs Increased 8-Fold Since 200 As Complexity Level Grew
March/April 2007
Research Article
Economics of New Oncology Drug Development
Journal of Clinical Oncology
Joseph DiMasi
1/10/2007
Impact Report
EMEA Meets Performance Goals, But Lags US FDA In Drug Approvals
January/February 2007
Commentary
Just Another Day at the Office?
The Scientist
Kenneth Kaitin
12/1/2006
Impact Report
Cost to Develop New Biotech Products is Estimated to Average $1.2 Billion
November/December 2006
Impact Report
Fastest Drug Developers Consistently Best Peers on Key Performance Metrics
September/October 2006
Research Article
Variability in the Costs of Institutional Review Board Oversight
Academic Medicine
Kenneth Getz
8/1/2006
Impact Report
Number of Vaccines Entering Clinical Study Rose Only Modestly Since 1990s
July/August 2006
Impact Report
New Drugs Entering Clinical Testing in Top 100 Firms Jumped 52% in 2003-05
May/June 2006
Impact Report
Fast Track Program Firmly Established in US Drug Development Landscape
March/April 2006
Book Chapter
Public and Patient Usage and Expectations for Clinical Trial Registries
Clinical Trial Registries
Kenneth Getz
1/1/2006
Impact Report
Longer Clinical Times Are Extending Time to Market For New Drugs in US
November/December 2005
Impact Report
Drug Safety Withdrawals in the US Not Linked to Speed of FDA Approval
September/October 2005
Commentary
Down the Critical Path: Who Should Lead?
Applied Clinical Trials
Kenneth Kaitin
8/1/2005
Letter from the Editor
Letter from the Editor
Contemporary Clinical Trials
Kenneth Getz
8/1/2005
Impact Report
US Pediatric Studies Incentive Led to New Labelling For Nearly 100 Drugs
July/August 2005
Research Article
Cooperative Research Ethics Review Boards: A Win-Win Solution?
IRB: Ethics & Human Research
Kenneth Getz
5/1/2005
Impact Report
Numbers of Active Investigators in FDA-Regulated Clinical Trials Drop
May/June 2005
Research Article
The Cost of Institutional Review Boards in Academic Medical Centers
The New England Journal of Medicine
Kenneth Getz
4/28/2005
Impact Report
Protein Therapeutic Success Rates Increase With Biotech Advances
March/April 2005
Research Article
Setting the Record Straight: Response to the Light and Warburton Rejoinder
Joseph DiMasi
1/1/2005
Impact Report
Decline in Drug Approvals is Driving Industry, FDA to Enhance Efficiency
January/February 2005
Impact Report
CRO Contribution to Drug Development is Substantial and Growing Globally
January/February 2006
Research Article
The Regulation and Approval of New Drugs in China
Drug Information Journal
Kenneth Kaitin
12/30/2004
Report
Assessing Claims About the Cost of New Drug Development: A Critique of the Public Citizen and TB Alliance Reports
Journal of Health Economics
Joseph DiMasi
11/1/2004
Impact Report
Incremental R&D Creates Safer, More Effectives Drugs & Fosters Competition
November/December 2004
Commentary
Looking Back, Looking Forward
Drug Information Journal
Kenneth Kaitin
10/1/2004
Impact Report
Cost Issues Increasingly Drive US Formulary and Clinical Guidelines
September/October 2004
Research Article
Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals
Annals of Internal Medicine
Kenneth Getz
8/17/2004
Research Article
R&D Costs and Returns by Therapeutic Category
Drug Information Journal
Joseph DiMasi
7/1/2004
Impact Report
FDA Requested Postmarketing Studies in 73% of Recent New Drug Approvals
July/August 2004
Commentary
Patents and R&D Incentives: Comments on the Hubbard and Love Trade Framework for Financing Pharmaceutical R&D
"W.H.O. Commision on Intellectual Property Rights, Innovation, and Public Health (CIPIH)"
Joseph DiMasi
6/25/2004
Research Article
Going Global
Applied Clinical Trials
Mary Jo Lamberti
6/1/2004
Impact Report
Therapeutic Class a Critical Determinant of Drug Development Time & Cost
May/June 2004
Impact Report
Faster Review, Longer Response Time Mark New EU Biopharmaceuticals
March/April 2004
Research Article
The Economics of Follow-On Drug Research and Development
Pharmacoeconomics
Joseph DiMasi
1/1/2004
Impact Report
High Cost of Drug Development Spurs New Ways to Assess and Manage Risk
January/February 2004
Impact Report
FDA's Fast Track Initiative Cut Total Drug Development Times By 3 Years
November/December 2003