TUFTS CSDD IMPACT REPORTS

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, hard-hitting authoritative data, analysis, and insights on essential topics in drug development. Concise by design, the results and insights presented in Tufts CSDD Impact Reports have been cited extensively in the trade press and in The New York Times, Boston Globe, Wall Street Journal, Forbes, Time Magazine, and the New England Journal of Medicine, among others.

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Participation Burden for Patients in Clinical Trials is Rising, Especially in Non-Oncology Studies

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Tufts CSDD Impact Reports present trusted research, objective evidence, and insights:

  • Charts and tables present key points and synthesized analysis, letting you focus on major strategic findings
  • Clear and concise bulleted takeaways save you time deciphering extensive text
  • Explanatory sidebars and definitions ensure a shared understanding of key concepts and terms

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Annual Individual Subscription
Tufts CSDD Impact Report Annual Individual Subscription: $675 USD Details: Six (6) Bi-monthly Issues, Electronic PDF Delivery. Purchase Individual Subscription

*Subscriber will receive six (6) reports starting the current issue from purchase date. This subscription is not archive access: older issues can be purchased for an additional cost * 
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Tufts CSDD Impact Report Single (1) Issue: $150 USD Details: One (1) Issue, Electronic PDF Delivery. Purchase Single Issue

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We offer 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. For more information, please contact us through email at csdd@tufts.edu. Purchase Corporate Multi-User Subscription

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Orders are processed manually within 24 hours of receipt, during the regular business hours of 9AM to 5PM ET Monday–Friday, excluding university holidays. Orders placed outside of business hours will be processed on the following business day. Reports are sent as an electronic attachment (PDF) along with an email receipt. If you do not receive your report within 24 hours, please contact us.

Request a copy of one of our recent Impact Reports:

2024

Participation burden for patients in clinical trials is rising, especially in non-oncology studies

September/October Vol. 26 No. 5

SUMMARY

Dollar value of one day delay in drug development is now 20% of blockbuster era levels.

July/August Vol. 26 No. 4

SUMMARY

Use of digital endpoints to collect clinical trial data is rapidly increasing.

May/June Vol. 26 No. 3

SUMMARY

Workplace microaggressions associated with staff turnover and poor performance.

March/April Vol. 26 No. 2

SUMMARY

Global site activation and patient enrollment strategies produce mixed results.

January/February Vol. 26 No. 1

SUMMARY

 

2023

Number of biotech products in late-stage clinical trials has quadrupled during the past decade.

November/December Vol. 25 No. 6

SUMMARY

Select socioeconomic factors highly associated with clinical trial attitudes and interest.

September/October Vol. 25 No. 5

SUMMARY

Approximately half of clinical trials use risk based quality management components

July/August Vol. 25 No. 4

SUMMARY

Protocol design scope and execution burden continue to rise, most notably in Phase III

May/June Vol. 25 No. 3

SUMMARY

Prevalence and mean number of protocol amendments increasing across all phases

March/April Vol. 25 No. 2

SUMMARY

Global sites optimistic about the future of clinical trials despite ongoing challenges

January/February Vol. 25 No. 1

SUMMARY

2022

Top CROs gain market share, close record number of M&A deals, improve productivity 

 November/December Vol. 24 No. 6

SUMMARY

DCTs Substantially Increase Financial Value Based on Key Performance Indicators 

September/October Vol. 24 No. 5

SUMMARY

Innovations Supporting Clinical Trial Execution Take Nearly Six Years to Adopt

July/August Vol. 24 No. 4

SUMMARY

In Europe, Demographic Under-Representation in Clinical Trials Persists

May/June Vol. 24 No. 3

SUMMARY

Cost Variation and Mis-Estimation Characterize Clinical Trial Budgets, Particularly in Early Phases. 

March/April Vol. 24 No. 2

SUMMARY

The Incidence of Protocol Deviations and Amendments is High and Rising

January/February Vol. 24 No. 1

SUMMARY

2021

New Study Finds Site Personnel Race and Ethnicity Highly Correlated with Diversity of Patients Enrolled

November/December Vol. 23 No. 6

SUMMARY | Press Release

Clinical Teams Working Remotely During the COVID-19 Pandemic Remain Highly Productive

September/October Vol. 23 No. 5

SUMMARY | Press Release

Biotech R&D Spending Grew by More Than 3x the Rate of Total Industry Spend in 2001-20 July/August Vol. 23 No. 4 SUMMARY | Press Release

Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Trials May/June Vol. 23 No. 3 SUMMARY | Press Release

Planned and Unplanned Mid-Study Updates Pose Major Challenge to Clinical Trial Timelines March/April Vol. 23 No. 2 SUMMARY | Press Release

Rising Protocol Design Complexity is Driving Rapid Growth in Clinical Trial Data Volume January/February Vol. 23 No. 1 SUMMARY | Press Release

2020

Global Clinical Trials Transition to Decentralized Models Abruptly, in Nuanced WaysNovember/December Vol. 22 No. 6 SUMMARY | Press Release

New Anti-infective Drugs Had a 14% Speed Advantage vs. Other Drugs During 2000-19 September/October Vol. 22 No. 5 SUMMARY | Press Release

Faster New Drug Approval Phases Are More Than Offset by Longer Clinical Times in U.S July/August Vol. 22 No. 4 SUMMARY | Press Release

New Benchmarks Quantify Demographic Under-Representation in Clinical Trials May/June Vol. 22 No. 3 SUMMARY | Press Release

Drug Developers Respond to Evolving Clinical Data Demands with New Strategies, Tactics March/April Vol. 22 No. 2 SUMMARY | Press Release

New Global Recruitment Performance Benchmarks Yield Mixed Results January/February Vol. 22 No. 1 SUMMARY | Press Release

2019

Vendor Qualification Process Volume and Complexity Require Substantial Time and Cost November/December Vol. 21 No. 6 SUMMARY | Press Release

Cancer Drug Approvals Grew from 4% of U.S. Total in the 1980s to 27% in 2010-18 September/October Vol. 21 No. 5 SUMMARY | Press Release

Growth in Rare Disease R&D in Challenging Development Strategy and Execution July/August Vol. 21 No. 4 SUMMARY | Press Release

Adoption of Artificial Intelligence is High Across Drug Development May/June Vol. 21 No. 3 SUMMARY | Press Release

Outsourcing Outpaces Internal Spending but Remains Tactical and Reactive March/April Vol. 21 No. 2 SUMMARY | Press Release

U.S. continues to Lead New Drug R&D, but Asia-Pacific is Starting to Rise January/February Vol. 21 No. 1 SUMMARY | Press Release

2018

Global Biotech Product Development Continues its Multi-Decade SurgeNovember/December Vol. 20 No. 6
SUMMARY | Press Release

CNS Drugs Take 20% Longer to Develop and to Approve vs. Non-CNS DrugsSeptember/October Vol. 20 No. 5
SUMMARY | Press Release

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

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

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

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

2017

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

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

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

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

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

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

2016

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

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

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

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

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

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

2015

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

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

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

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

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

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

2014

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

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

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

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

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

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

2013

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

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

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

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

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

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

2012

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

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

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

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

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

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


TUFTS CSDD IMPACT REPORTS 1999-2011

Explore the electronic archive of Tufts CSDD Impact Reports from 1999 - 2011.
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