Publication Library & Research Findings

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585 Results
Impact Report
New Breakthrough Therapy Designation Program Aims to Cut Clinical Trial Time
January/February 2014
Research Article
New Governance Mechanisms to Optimize Protocol Design
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Kenneth Getz, Jennifer Kim
12/30/2013
Research Article
Impact of In-Pharmacy Education on Patients’ Knowledge and Attitudes About Clinical Trials
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2013
Whitepaper
A New Tool for Predicting Marketing Approval of Oncology Drugs
December 2013
Editorial
Drug Development Study Designs Have Reached the Danger Zone
Expert Review of Clinical Pharmacology
Kenneth Getz
11/14/2013
Impact Report
Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically
November/December 2013
Impact Report
Causes of Clinical Failures Vary Widely by Therapeutic Class, Phase of Study
September/October 2013
Research Article
Characterizing the Global Market for Contract R&D Services
Monographic supplement series CROs/CMOs: Chimica Oggi - Chemistry Today
Mary Jo Lamberti, Jennifer Kim, Kenneth Getz
7/1/2013
Impact Report
Annual Approvals For Neglected Diseases Rose From 2.6 in 2000-08 to 5 in 2009-12
July/August 2013
Research Article
Characterizing the Cost of Non-Clinical Development Activity
Contract Pharma
Jennifer Kim, Kenneth Getz
6/5/2013
Research Article
Clinical Approval Success Rates for Investigational Cancer Drugs
Clinical Pharmacology & Therapeutics
Joseph DiMasi
6/5/2013
Research Article
Tracking Trial Cost Drivers: The Impact of Comparator Drugs and Co-Therapies
Pharmaceutical Executive
Mary Jo Lamberti, Kenneth Getz
5/1/2013
Research Article
Unfulfilled Translation Opportunities in Industry Sponsored Clinical Trials
Contemporary Clinical Trials
Kenneth Getz
5/1/2013
Impact Report
Clinical Success Rates for New Cancer Drugs Double While More Enter Testing
May/June 2013
Whitepaper
The Adoption and Impact of Adaptive Trial Designs
May 2013
Impact Report
Global Site Landscape Remains Highly Fragmented With Variable Performance
March/April 2013
Research Article
Benchmarking the Study Initiation Process
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz
1/1/2013
Research Article
The Scoop on Drug Shortages
Pharmaceutical Executive
Mary Jo Lamberti, Kenneth Getz
1/1/2013
Research Article
Oncology Drug Development and Approval of Systemic Anticancer Therapy by the US Food and Drug Administration
Oncologist
Kenneth Kaitin, Kenneth Getz
1/1/2013
Impact Report
89% of Trials Meet Enrollment, But Times Slip, Half of Sites Under-Enroll
January/February 2013
Research Article
Mapping and Characterizing the Development Pathway from Non-Clinical through Early Clinical Drug Development
Pharmaceutical Medicine
Kenneth Getz
12/23/2012
Research Article
Research and Development Costs for New Drugs by Therapeutic Category
PharmacoEconomics
Joseph DiMasi
11/15/2012
Commentary
Weighing Access and Affordability
PharmTech
Kenneth Kaitin
11/2/2012
Impact Report
One in Five Procedures Generates Extraneous Clinical Trials Data
November/December 2012
Research Article
Translational Research and the Evolving Landscape for Biomedical Innovation
Journal of Investigative Medicine
Kenneth Kaitin
10/1/2012
Book Chapter
R&D Costs and Returns to New Drug Development: A Review of the Evidence
The Oxford Handbook of the Economics of the Biopharmaceutical Industry
Joseph DiMasi
9/18/2012
Research Article
The Economics of Follow-On Drug Research and Development
PharmacoEconomics
Joseph DiMasi
9/3/2012
Impact Report
Oncology Drugs Get Faster Approvals Than Non-Oncology Drugs in US
September/October 2012
Research Article
Microaggressions, Interrupted: The Experience and Effects of Gender Microaggressions for Women in STEM
Journal of Business Ethics
Jennifer Kim
8/5/2012
Research Article
Evaluating the Impact of Patient Recruitment and Retention Practices
Drug Information Journal
Mary Jo Lamberti, Kenneth Getz
7/13/2012
Impact Report
US Offers Patients Faster, Greater Access to Cancer Drugs Than Europe
July/August 2012
Research Article
Resizing the Global Contract R&D Services Market
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
5/30/2012
Impact Report
User Fee Era in US Currently Poses Mixed Regulatory Burden For Sponsors
May/June 2012
Whitepaper
Academic-Industry Partnerships for Biopharmaceutical Research & Development: Advancing Medical Science in the U.S.
April 2012
Impact Report
Pace of CNS Drug Development and FDA Approvals Lag Other Drug Classes
March/April 2012
Research Article
FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
2/15/2012
Research Article
Trends and Novel Approaches to Clinical Supply Outsourcing
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
1/23/2012
Impact Report
Study Monitor Workload High & Varied With Wide Disparity By Global Region
January/February 2012
Commentary
Creating Innovation Nodes to Meet Unmet Medical Needs
PharmTech
Kenneth Kaitin
12/2/2011
Impact Report
New mAbs Entering Clinical Study Rose Steadily From 1997 Through 2010
November/December 2011
Book Chapter
Clinical Research, Patient Care, and Learning That is Real-Time and Continuous: Enhancing the Culture of Patient Contributions to Learning in Health Care
Patients Charting the Course: Citizen Engagement in the Learning Health System
Kenneth Getz
10/21/2011
Commentary
Program Chair Reflects upon DIA 2011
Drug Information Journal
Kenneth Getz
9/1/2011
Impact Report
Nearly 60% of All Protocols Require Amendments; One-Third Are Avoidable
September/October 2011
Commentary
A Dearth of New Meds: Drugs to Treat Neuropsychiatric Disorders Have Become Too Risky for Big Pharma
Scientific American
Kenneth Kaitin
8/1/2011
Research Article
Variability in Protocol Design Complexity by Phase and Therapeutic Area
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Kenneth Getz
7/1/2011
Commentary
Transforming R&D Through Open Innovation
Applied Clinical Trials
Kenneth Kaitin, Kenneth Getz
7/1/2011
Research Article
Are Pharmacists a Viable Channel for Education about Clinical Trial Participation?
Drug Information Journal
Kenneth Getz
7/1/2011
Impact Report
Lack of Clinically Useful Diagnostics Hinder Growth in Personalized Medicines
July/August 2011
Commentary
21st Century Innovation
PharmTech
Kenneth Kaitin
6/2/2011
Research Article
Measuring the Incidence, Causes, and Repercussions of Protocol Amendments
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Kenneth Getz
5/1/2011