Publication Library & Research Findings

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Impact Report
Large Pharma Success Rate For Drugs Entering Clinical Trials in 1993-04: 16%
July/August 2009
Research Article
Successful Outsourcing: Tracking Global CRO Usage
Applied Clinical Trials
Kenneth Getz
6/1/2009
Impact Report
Therapeutic Peptides in Clinical Study in 2000-07 Nearly Doubled 1990s Rate
May/June 2009
Research Article
Subjects' View of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results from the Experiences of Participants in Clinical Trials (EPIC) Study
Journal of Medical Ethics
Kenneth Getz
3/1/2009
Impact Report
75% of US Health Plans Reimburse Off-Label Uses of Prescription Drugs
March/April 2009
Impact Report
Current Investigator Landscape Poses a Growing Challenge For Sponsors
January/February 2009
Impact Report
While Total Approvals Decline, US is Preferred Market for First Launch
November/December 2008
Research Article
Assessing the Impact of Protocol Design Changes on Clinical Trial Performance
American Journal of Therapeutics
Kenneth Kaitin, Kenneth Getz
9/1/2008
Impact Report
Fast Track Designations More Than Doubled During the Last Five Years
September/October 2008
Impact Report
Postmarketing Studies Are Becoming the Norm in US, Europe, and Japan
July/August 2008
Research Article
The Truth About Drug Innovation: Thirty-Five Summary Case Histories on Private Sector Contributions to Pharmaceutical Science
Manhattan Institute for Policy Research
Joseph DiMasi
6/1/2008
Impact Report
Drug Plans Non-Compliant With Medicare Regulations in Six Therapeutic Classes
May/June 2008
Commentary
Misleading Congress About Drug Development: Reply
"Journal of Health Politics, Policy and Law"
Joseph DiMasi
4/1/2008
Book Chapter
Investigator/Institution
Wiley Encyclopedia of Clinical Trials
Kenneth Getz
3/14/2008
Impact Report
Number of mAbs Entering Clinical Study Nearly Tripled in Last Decade
March/April 2008
Research Article
Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
1/1/2008
Commentary
Follow On Drugs and Indications: the Importance of Incremental Innovation to Medical Practice
American Journal of Therapeutics
Kenneth Kaitin
1/1/2008
Research Article
Racial Disparities Among Clinical Research Investigators
American Journal of Therapeutics
Kenneth Getz
1/1/2008
Commentary
Offshoring: Cost-Effective Clinical Research
Pharma Focus Asia
Kenneth Kaitin
1/1/2008
Impact Report
Growing Protocol Design Complexity Stresses Investigators, Volunteers
January/February 2008
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