tufts csdd impact reports

Analysis and insight into critical drug development issues. Cutting edge information. Original research. Your most reliable guide to drug development.

Tufts CSDD Impact Reports are a bi-monthly subscription-based publication presenting original research, analysis, and insights on a broad variety of topics, ranging from Tufts CSDD’s current drug development metrics analyses, to global pharmaceutical reimbursement policies. Research presented in Tufts CSDD Impact Reports have been cited in the Boston Globe, Wall Street Journal, Forbes, Time magazine, and the New England Journal of Medicine, among others.

Tufts CSDD Impact Reports make critical information readily accessible.

  • Charts and tables present key points, letting you focus on major findings.
  • Clear, concise—and brief—bulleted items highlight key findings, saving you time deciphering extensive text.
  • Explanatory sidebars and definitions ensure a shared understanding of key concepts and terms.

    Single Issues

    All Tufts CSDD Impact Reports are available for single issue ordering. Single issues can be purchased at $125 per issue. If you would like to request more than two issues, please contact Tufts CSDD at 617-636-2170 or email csdd@tufts.edu.

    Annual subscriptions

    Annual Electronic subscriptions for single users includes six (6) bi-monthly issues of the Tufts CSDD Impact Report, sent via PDF. 

    Corporate Multi-Reader Subscriptions

    Tufts CSDD offers both individual and corporate subscriptions to Tufts CSDD Impact Reports. Corporate subscriptions provide everyone in your department or organization immediate access to these timely reports. Priced to be cost effective, corporate subscriptions offer a significant volume discount off the annual individual subscription fee. If you are interested in a multi-reader subscription, please contact us by phone at 617-636-2170 or by email.


    Tufts CSDD Impact Report Archives

    2018

    Rising Protocol Complexity is Hindering Study Performance, Cost, and Efficiency
    July/August, Vol. 20 No. 4
    SUMMARY
    Press Release

    Patent-to-launch Time for Orphan Drugs is 2.3 Years Longer vs. Other Drugs
    May/June, Vol. 20 No. 3
    SUMMARY
    Press Release

    Clinical Data Volume and Diversity Pose Increasing Challenges and Delays
    Jan/Feb, Vol. 20 No. 1
    SUMMARY
    Press Release

    Clinical Site Initiation Process Remains Lengthy and Highly Inefficient
    March/April, Vol. 20 No. 2
    SUMMARY
    Press Release


    2017

    Cardiovascular Drug Approval Rate in the U.S. Fell as Development Time Rose
    Sep/Oct, Vol. 19 No.5
    SUMMARY
    Press Release

    Real World Evidence Use in Clinical & Post-Approval Research Set to Expand
    Nov/Dec, Vol. 19 No.6
    SUMMARY
    Press Release

    Biotech Products Accounted for 35% of All New FDA Approvals in 2000-16
    May/Jun, Vol. 19 No. 3
    SUMMARY
    Press Release

    Abuse-Deterrent Opioid Development and Uptake Are Tied to Efficacy and Regulatory/Payer Policies
    Jul/Aug, Vol. 19 No. 4
    SUMMARY
    Press Release

    Poor Physician and Nurse Engagement Driving Low Patient Recruitment
    Jan/Feb, Vol. 19 No. 1
    SUMMARY
    Press Release

    Approval Time for 505(b)(2) Drugs is Nearly Five Months Longer Than for NMEs
    Mar/Apr, Vol. 19 No. 2
    SUMMARY
    Press Release


    2016

    Diabetes Drug Development is Riskier Compared to All Drug Development
    Sep/Oct, Vol. 18 No. 5
    SUMMARY
    Press Release

    Pediatric Regulatory Science, Clinical Trial Networks Hold Promise for Studies
    Nov/Dec, Vol. 18 No. 6
    SUMMARY
    Press Release

    Expected Growth in PBM Exclusion Lists Poses a Challenge to Drug Developers
    May/June, Vol. 18 No. 3
    SUMMARY
    Press Release

    Global Regenerative Medicine Market is Poised for Strong Growth
    Jul/Aug, Vol. 18 No. 4
    SUMMARY
    Press Release

    Amendments Reduce Number of Patients, But at High Cost, Longer Study Times
    January/February, Vol. 18 No. 1
    SUMMARY
    Press Release

    Promise of Immuno-Oncology Therapies is Boosting R&D Funding, Alliances
    March/April, Vol. 18 No. 2
    SUMMARY
    Press Release


    2015

     

    Adverse Drug Event Reporting in U.S. Beset by Incompleteness and Inaccuracy
    September/October, Vol. 17 No.5
    SUMMARY
    Press Release

    First-in-Class Drugs in Competitive Development Races With Later Entrants
    November/December, Vol. 17 No. 6
    SUMMARY
    Press Release

    Personalized Medicine Gains Traction But Still Faces Multiple Challenges
    May/June 2015, Vol. 17 No. 3
    SUMMARY
    Press Release

    Vaccine Products in the R&D Pipeline Have More Than Tripled Since 2005
    July/August 2015, Vol. 17 No. 4
    SUMMARY
    Press Release

    High Turnover, Protocol Noncompliance Plague the Global Site Landscape
    January/February 2015, Vol. 17 No. 1
    SUMMARY
    Press Release

    Biosimilars Entering the U.S. Market Are Likely to Face Multiple Challenges
    March/April 2015, Vol. 17 No. 2
    SUMMARY
    Press Release


    2014

    Protocol Design Optimization Starting to Improve Study Performance
    September/October 2014, Vol. 16 No. 5
    SUMMARY
    Press Release

    CNS Drugs Take Longer to Develop, Have Lower Success Rates, Than Other Drugs
    November/December 2014, Vol. 16 No. 6
    SUMMARY
    Press Release

    Collaboration & Risk-Sharing Programs Experience Longer Development Times
    May/June 2014, Vol. 16 No. 3
    SUMMARY
    Press Release

    Patients Face New Challenges Accessing a Growing Number of Orphan Drugs
    July/August 2014, Vol. 16 No. 4
    SUMMARY
    Press Release

    New Breakthrough Therapy Designation Program Aims to Cut Clinical Trial Time
    January/February 2014, Vol. 16 No. 1
    SUMMARY
    Press Release

    Drug Sponsors Tread Cautiously Using Social Media to Aid Clinical Research
    March/April 2014, Vol. 16 No. 2
    SUMMARY
    Press Release


    2013

    Causes of Clinical Failures Vary Widely by Therapeutic, Phase of Study
    September/October 2013, Vol. 15 No. 5
    SUMMARY
    Press Release

    Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically
    November/December 2013, Vol. 15 No. 6
    SUMMARY
    Press Release

    Clinical Success Rates for New Cancer Drugs Double While More Enter Testing
    May/June 2013, Vol. 15 No. 3
    SUMMARY
    Press Release

    Annual Approvals for Neglected Diseases Rose from 2.6 in 2000-08 to 5 in 2009-12
    July/August 2013, Vol. 15 No. 4
    SUMMARY
    Press Release

    89% of Trials Meet Enrollment, but Timelines Slip, Half of Sites Under-Enroll
    January/February 2013, Vol. 15 No. 1
    SUMMARY
    Press Release

    Global Site Landscape Remains Highly Fragmented with Variable Performance
    March/April 2013, Vol. 15 No. 2
    SUMMARY
    Press Release


    2012

    Oncology Drugs Get Faster Approvals Than Non-Oncology Drugs in U.S.
    September/October 2012, Vol. 14 No. 5
    SUMMARY
    Press Release

    One in Five Procedures Generates Extraneous Clinical Trials Data
    November/December 2012, Vol. 14 No. 6
    SUMMARY
    Press Release

    User Fee Era in U.S. Currently Poses Mixed Regulatory Burden for Sponsors
    May/June 2012, Vol. 14 No. 3
    SUMMARY
    Press Release

    U.S. Offers Patients Faster, Greater Access to Cancer Drugs Than Europe
    July/August 2012, Vol. 14 No. 4
    SUMMARY
    Press Release

    Study Monitor Workload High & Varied with Wide Disparity by Global Region
    January/February 2012, Vol. 14 No. 1
    SUMMARY
    Press Release

    Pace of CNS Drug Development and FDA Approvals Lags Other Drug Classes
    March/April 2012, Vol. 14 No. 2
    SUMMARY
    Press Release


    2011

    Nearly 60% of All Protocols Require Amendments; One-Third Are Avoidable
    September/October 2011, Vol. 13 No. 5
    SUMMARY
    Press Release

    New mAbs Entering Clinical Study Rose Steadily from 1997 Through 2010
    November/December 2011, Vol. 13 No. 6
    SUMMARY
    Press Release

    Biopharmaceutical Product Approvals in the U.S. Rose Dramatically in 2000s 
    May/June 2011, Vol. 13 No. 3
    SUMMARY
    Press Release

    Lack of Clinically Useful Diagnostics Hinder Growth in Personalized Medicines
    July/August 2011, Vol. 13 No. 4
    SUMMARY
    Press Release

    U.S. Healthcare Stakeholders Uncertain on Benefits of Risk Evaluation Strategy
    January/February 2011, Vol. 13 No. 1
    SUMMARY
    Press Release

    New or Modified Indications for Existing Drugs Have Steadily Increased in U.S.
    March/April 2011, Vol. 13 No. 2
    SUMMARY
    Press Release


    2010

    Clinical Approval Success Highest for Smallest Firms Among the Top 50
    September/October 2010, Vol. 12 No. 5
    SUMMARY
    Press Release

    Personalized Medicine is Playing a Growing Role in Development Pipelines
    November/December 2010, Vol. 12 No. 6
    SUMMARY
    Press Release

    Rising Protocol Complexity, Execution Burden Varies Widely by Phase and TA  
    May/June 2010, Vol. 12 No. 3
    SUMMARY
    Press Release

    Comparative Effectiveness Research Impacts Patient Access to Cancer Drugs
    July/August 2010, Vol. 12 No. 4
    SUMMARY
    Press Release

    Rising Demand is Expanding Scope and Workload of Regulatory Affairs Function
    March/April 2010, Vol. 12 No. 2
    SUMMARY
    Press Release

    U.S. Orphan Product Designations More Than Doubled from 2000-02 to 2006-08
    January/February 2010, Vol. 12 No. 1
    SUMMARY
    Press Release


    2009

    Marketing Exclusivity for First–in–Class Drugs has Shortened to 2.5 years
    September/October 2009, Vol. 11, No. 5
    SUMMARY
    Press Release

    Drug Approvals for Neglected Diseases Increase Along with More R&D Funding
    November/December 2009, Vol. 11 No. 6
    SUMMARY
    Press Release

    Therapeutic Peptides in Clinical Study in 2000–07 Nearly Doubled 1990s Rate
    May/June 2009, Vol. 11, No. 3
    SUMMARY
    Press Release

    Large Pharma Success Rate for Drugs Entering Clinical Trials in 1993–04: 16%
    July/August 2009 Vol. 11, No. 4
    SUMMARY
    Press Release

    Current Investigator Landscape Poses a Growing Challenge for Sponsors
    January/February 2009, Vol.11, No.1
    SUMMARY
    Press Release

    75% of U.S. Health Plans Reimburse Off–Label Uses of Prescription Drugs
    March/April 2009, Vol. 11, No. 2
    SUMMARY
    Press Release


    2008

    Fast Track Designations More Than Doubled During the Last Five Years
    September/October 2008, Vol.10, No.5
    SUMMARY
    Press Release

    While Total Approvals Decline, U.S. is Preferred Market for First Launch
    November/December 2008, Vol.10, No.6
    SUMMARY
    Press Release

    Drug Plans Non–Compliant with Medicare
    May/June 2008, Vol.10, No.3
    SUMMARY
    Press Release

    Postmarketing Studies are Becoming the Norm in U.S., Europe, and Japan
    July/August 2008 Vol.10 No.4
    SUMMARY
    Press Release

    Growing Protocol Design Complexity Stresses Investigators, Volunteers
    January/February 2008, Vol.10, No.1
    SUMMARY
    Press Release

    Number of mAbs Entering Clinical Study Nearly Tripled in Last Decade
    March/April 2008, Vol.10, No.2
    SUMMARY
    Press Release 


    2007

    Despite More Cancer Drugs in R&D, Overall U.S. Approval Rate is 8%
    September/October 2007, Vol.9, No.5
    SUMMARY
    Press Release 

    Notable Gender & Racial Disparities Exist Among Clinical Investigators
    November/December 2007, Vol.9, No.6
    SUMMARY
    Press Release 

    Challenges Loom for Postmarketing Study Commitments; Benefits Unclear
    May/June 2007, Vol. 9, No. 3
    SUMMARY
    Press Release 

    Follow-On Drugs and Indications Play Key Role for World Health Organization
    July/August 2007, Vol. 9, No. 4
    SUMMARY
    Press Release 

    EMEA Meets Performance Goals, but Lags U.S. FDA in Drug Approvals
    January/February 2007 Vol.9 No.1
    SUMMARY
    Press Release 

    Pediatric Study Costs Rose Substantially from 2000 as Complexity Grew
    March/April 2007 Vol. 9, No. 2
    SUMMARY
    Press Release