Tufts CSDD Impact Reports present trusted research, objective evidence, and insights:
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March / April 2025
Site Feasibility Assessments & Qualification Visits Entail Lengthy Response Periods, With Mixed Results
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2024
November/December Vol. 26 No. 6
Denigrating and Discriminatory Study Staff Behaviors Harming Patient Enrollment Diversity
September/October Vol. 26 No. 5
Participation burden for patients in clinical trials is rising, especially in non-oncology studies
July/August Vol. 26 No. 4
Dollar value of one day delay in drug development is now 20% of blockbuster era levels.
May/June Vol. 26 No. 3
Use of digital endpoints to collect clinical trial data is rapidly increasing.
March/April Vol. 26 No. 2
Workplace microaggressions associated with staff turnover and poor performance.
January/February Vol. 26 No. 1
Global site activation and patient enrollment strategies produce mixed results.
2023
November/December Vol. 25 No. 6
Number of biotech products in late-stage clinical trials has quadrupled during the past decade.
September/October Vol. 25 No. 5
Select socioeconomic factors highly associated with clinical trial attitudes and interest.
July/August Vol. 25 No. 4
Approximately half of clinical trials use risk based quality management components
May/June Vol. 25 No. 3
Protocol design scope and execution burden continue to rise, most notably in Phase III
March/April Vol. 25 No. 2
Prevalence and mean number of protocol amendments increasing across all phases
January/February Vol. 25 No. 1
Global sites optimistic about the future of clinical trials despite ongoing challenges
2022
November/December Vol. 24 No. 6
Top CROs gain market share, close record number of M&A deals, improve productivity
September/October Vol. 24 No. 5
DCTs Substantially Increase Financial Value Based on Key Performance Indicators
July/August Vol. 24 No. 4
Innovations Supporting Clinical Trial Execution Take Nearly Six Years to Adopt
May/June Vol. 24 No. 3
In Europe, Demographic Under-Representation in Clinical Trials Persists
March/April Vol. 24 No. 2
Cost Variation and Mis-Estimation Characterize Clinical Trial Budgets, Particularly in Early Phases.
January/February Vol. 24 No. 1
The Incidence of Protocol Deviations and Amendments is High and Rising
2021
November/December Vol. 23 No. 6
New Study Finds Site Personnel Race and Ethnicity Highly Correlated with Diversity of Patients Enrolled
September/October Vol. 23 No. 5
Clinical Teams Working Remotely During the COVID-19 Pandemic Remain Highly Productive
July/August Vol. 23 No. 4
Biotech R&D Spending Grew by More Than 3x the Rate of Total Industry Spend in 2001-20
May/June Vol. 23 No. 3
Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Trials
March/April Vol. 23 No. 2
Planned and Unplanned Mid-Study Updates Pose Major Challenge to Clinical Trial Timelines
January/February Vol. 23 No. 1
Rising Protocol Design Complexity is Driving Rapid Growth in Clinical Trial Data Volume
2020
November/December Vol. 22 No. 6
Global Clinical Trials Transition to Decentralized Models Abruptly, in Nuanced Ways
September/October Vol. 22 No. 5
New Anti-infective Drugs Had a 14% Speed Advantage vs. Other Drugs During 2000-19
July/August Vol. 22 No. 4
Faster New Drug Approval Phases Are More Than Offset by Longer Clinical Times in U.S
May/June Vol. 22 No. 3
New Benchmarks Quantify Demographic Under-Representation in Clinical Trials
March/April Vol. 22 No. 2
Drug Developers Respond to Evolving Clinical Data Demands with New Strategies, Tactics
January/February Vol. 22 No. 1
New Global Recruitment Performance Benchmarks Yield Mixed Results
2019
November/December Vol. 21 No. 6
Vendor Qualification Process Volume and Complexity Require Substantial Time and Cost
September/October Vol. 21 No. 5
Cancer Drug Approvals Grew from 4% of U.S. Total in the 1980s to 27% in 2010-18
July/August Vol. 21 No. 4
Growth in Rare Disease R&D in Challenging Development Strategy and Execution
May/June Vol. 21 No. 3
Adoption of Artificial Intelligence is High Across Drug Development
March/April Vol. 21 No. 2
Outsourcing Outpaces Internal Spending but Remains Tactical and Reactive
January/February Vol. 21 No. 1
U.S. continues to Lead New Drug R&D, but Asia-Pacific is Starting to Rise
2018
November/December Vol. 20 No. 6
Global Biotech Product Development Continues its Multi-Decade Surge
September/October Vol. 20 No. 5
CNS Drugs Take 20% Longer to Develop and to Approve vs. Non-CNS Drugs
July/August, Vol. 20 No. 4
Rising Protocol Complexity is Hindering Study Performance, Cost, and Efficiency
May/June, Vol. 20 No. 3
Patent-to-launch Time for Orphan Drugs is 2.3 Years Longer vs. Other Drugs
March/April, Vol. 20 No. 2
Clinical Site Initiation Process Remains Lengthy and Highly Inefficient
Jan/Feb, Vol. 20 No. 1
Clinical Data Volume and Diversity Pose Increasing Challenges and Delays
2017
Nov/Dec, Vol. 19 No.6
Real World Evidence Use in Clinical & Post-Approval Research Set to Expand
Sep/Oct, Vol. 19 No.5
Cardiovascular Drug Approval Rate in the U.S. Fell as Development Time Rose
Jul/Aug, Vol. 19 No. 4
Abuse-Deterrent Opioid Development and Uptake Are Tied to Efficacy and Regulatory/Payer Policies
May/Jun, Vol. 19 No. 3
Biotech Products Accounted for 35% of All New FDA Approvals in 2000-16
Mar/Apr, Vol. 19 No. 2
Approval Time for 505(b)(2) Drugs is Nearly Five Months Longer Than for NMEs
Jan/Feb, Vol. 19 No. 1
Poor Physician and Nurse Engagement Driving Low Patient Recruitment
2016
Nov/Dec, Vol. 18 No. 6
Pediatric Regulatory Science, Clinical Trial Networks Hold Promise for Studies
Sep/Oct, Vol. 18 No. 5
Diabetes Drug Development is Riskier Compared to All Drug Development
Jul/Aug, Vol. 18 No. 4
Global Regenerative Medicine Market is Poised for Strong Growth
May/June, Vol. 18 No. 3
Expected Growth in PBM Exclusion Lists Poses a Challenge to Drug Developers
March/April, Vol. 18 No. 2
Promise of Immuno-Oncology Therapies is Boosting R&D Funding, Alliances
January/February, Vol. 18 No. 1
Amendments Reduce Number of Patients, But at High Cost, Longer Study Times
2015
November/December, Vol. 17 No. 6
First-in-Class Drugs in Competitive Development Races With Later Entrants
September/October, Vol. 17 No.5
Adverse Drug Event Reporting in U.S. Beset by Incompleteness and Inaccuracy
July/August 2015, Vol. 17 No. 4
Vaccine Products in the R&D Pipeline Have More Than Tripled Since 2005
May/June 2015, Vol. 17 No. 3
Personalized Medicine Gains Traction But Still Faces Multiple Challenges
March/April 2015, Vol. 17 No. 2
Biosimilars Entering the U.S. Market Are Likely to Face Multiple Challenges
January/February 2015, Vol. 17 No. 1
High Turnover, Protocol Noncompliance Plague the Global Site Landscape
2014
November/December 2014, Vol. 16 No. 6
CNS Drugs Take Longer to Develop, Have Lower Success Rates, Than Other Drugs
September/October 2014, Vol. 16 No. 5
Protocol Design Optimization Starting to Improve Study Performance
July/August 2014, Vol. 16 No. 4
Patients Face New Challenges Accessing a Growing Number of Orphan Drugs
May/June 2014, Vol. 16 No. 3
Collaboration & Risk-Sharing Programs Experience Longer Development Times
March/April 2014, Vol. 16 No. 2
Drug Sponsors Tread Cautiously Using Social Media to Aid Clinical Research
January/February 2014, Vol. 16 No. 1
New Breakthrough Therapy Designation Program Aims to Cut Clinical Trial Time
2013
November/December 2013, Vol. 15 No. 6
Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically
September/October 2013, Vol. 15 No. 5
Causes of Clinical Failures Vary Widely by Therapeutic, Phase of Study
July/August 2013, Vol. 15 No. 4
Annual Approvals for Neglected Diseases Rose from 2.6 in 2000-08 to 5 in 2009-12
May/June 2013, Vol. 15 No. 3
Clinical Success Rates for New Cancer Drugs Double While More Enter Testing
March/April 2013, Vol. 15 No. 2
Global Site Landscape Remains Highly Fragmented with Variable Performance
January/February 2013, Vol. 15 No. 1
89% of Trials Meet Enrollment, but Timelines Slip, Half of Sites Under-Enroll
2012
November/December 2012, Vol. 14 No. 6
One in Five Procedures Generates Extraneous Clinical Trials Data
September/October 2012, Vol. 14 No. 5
Oncology Drugs Get Faster Approvals Than Non-Oncology Drugs in U.S.
July/August 2012, Vol. 14 No. 4
U.S. Offers Patients Faster, Greater Access to Cancer Drugs Than Europe
May/June 2012, Vol. 14 No. 3
User Fee Era in U.S. Currently Poses Mixed Regulatory Burden for Sponsors
March/April 2012, Vol. 14 No. 2
Pace of CNS Drug Development and FDA Approvals Lags Other Drug Classes
January/February 2012, Vol. 14 No. 1
Study Monitor Workload High & Varied with Wide Disparity by Global Region
TUFTS CSDD IMPACT REPORTS 1999-2011
Explore the electronic archive of Tufts CSDD Impact Reports from 1999 - 2011.
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