Tufts CSDD Impact Reports Single Issue

2013

Clinical success rates for new cancer drugs double while more enter testing
May/June 2013, Vol. 15 No. 3

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Global site landscape remains highly fragmented with variable performance
March/April 2013, Vol. 15 No. 2

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89% of trials meet enrollment, but timelines slip, half of sites under-enroll
January/February 2013, Vol. 15 No. 1

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2012

One in five procedures generates extraneous clinical trials data
November/December 2012, Vol. 14 No. 6

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Onocology drugs get faster approvals than non-oncology drugs in U.S.
September/October 2012, Vol. 14 No. 5

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U.S. offers patients faster, greater access to cancer drugs than Europe
July/August 2012, Vol. 14 No. 4

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User fee era in U.S. currently poses mixed regulatory burden for sponsors
May/June 2012, Vol. 14 No. 3

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Pace of CNS drug development and FDA approvals lags other drug classes
March/April 2012, Vol. 14 No. 2

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Study monitor workload high & varied with wide disparity by global region
January/February 2012, Vol. 14 No. 1

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2011

New mAbs entering clinical study rose steadily from 1997 through 2010
November/December 2011, Vol. 13 No. 6

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Nearly 60% of all protocols require amendments; one-third are avoidable
September/October 2011, Vol. 13 No. 5

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Lack of clinically useful diagnostics hinder growth in personalized medicines
July/August 2011, Vol. 13 No. 4

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Biopharmaceutical product approvals in the U.S. rose dramatically in 2000s 
May/June 2011, Vol. 13 No. 3

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New or modified indications for existing drugs have steadily increased in U.S.
March/April 2011, Vol. 13 No. 2

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U.S. healthcare stakeholders uncertain on benefits of risk evaluation strategy
January/February 2011, Vol. 13 No. 1

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2010

Personalized medicine is playing a growing role in development pipelines
November/December 2010, Vol. 12 No. 6

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Clinical approval success highest for smallest firms among the top 50
September/October 2010, Vol. 12 No. 5

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Comparative effectiveness research impacts patient access to cancer drugs
July/August 2010, Vol. 12 No. 4

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Rising protocol complexity, execution burden varies widely by phase and TA   
May/June 2010, Vol. 12 No. 3  
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Rising demand is expanding scope and workload of regulatory affairs function
March/April 2010, Vol. 12 No. 2
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U.S. orphan product designations more than doubled from 2000-02 to 2006-08
January/February 2010, Vol. 12 No. 1
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2009

Drug approvals for neglected diseases increase along with more R&D funding
November/December 2009, Vol. 11 No. 6
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Marketing exclusivity for first–in–class drugs has shortened to 2.5 years
September/October 2009, Vol. 11, No. 5
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Large pharma success rate for drugs entering clinical trials in 1993–04: 16%
July/August 2009 Vol. 11, No. 4
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Therapeutic peptides in clinical study in 2000–07 nearly doubled 1990s rate
May/June 2009, Vol. 11, No. 3
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75% of U.S. health plans reimburse off–label uses of prescription drugs
March/April 2009, Vol. 11, No. 2
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Current investigator landscape poses a growing challenge for sponsors
January/February 2009, Vol.11, No.1
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2008

While total approvals decline, U.S. is preferred market for first launch
November/December 2008, Vol.10, No.6
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Fast track designations more than doubled during the last five years
September/October 2008, Vol.10, No.5
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Postmarketing studies are becoming the norm in U.S., Europe, and Japan
July/August 2008 Vol.10 No.4
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Drug plans non–compliant with Medicare
May/June 2008, Vol.10, No.3
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Number of mAbs entering clinical study nearly tripled in last decade
March/April 2008, Vol.10, No.2
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Growing protocol design complexity stresses investigators, volunteers
January/February 2008, Vol.10, No.1
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2007

Notable gender & racial disparities exist among clinical investigators
November/December 2007, Vol.9, No.6
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Despite more cancer drugs in R&D, overall U.S. approval rate is 8%
September/October 2007, Vol.9, No.5 
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Follow-on drugs and indications play key role for World Health Organization
July/August 2007, Vol. 9, No. 4
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Challenges loom for postmarketing study commitments; benefits unclear
May/June 2007, Vol. 9, No. 3
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Pediatric Study Costs Rose Substantially from 2000 as Complexity Grew
March/April 2007 Vol. 9, No. 2
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EMEA meets performance goals, but lags U.S. FDA in drug approvals
January/February 2007 Vol.9 No.1
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