PRESS RELEASE: Tufts CSDD Impact Report September/October 2018, Vol. 20 No.5, Available Now

FOR IMMEDIATE RELEASE

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CNS Drugs Take 20% Longer to Develop and 38% Longer to Approve vs. Non-CNS Drugs, According to the Tufts Center for the Study of Drug Development

BOSTON – Sept. 11, 2018 – Developing drugs to treat central nervous system (CNS) disorders on average required 20% more time than other drugs that won marketing approval in the United States from 2000 through 2017, and took 38% longer to win that approval, according to a newly completed analysis by the Tufts Center for the Study of Drug Development.

"CNS drugs face greater development challenges compared to non-CNS drugs due, in large part, to a poor understanding of the underlying pathophysiology of many of the disorders they seek to treat, as well as difficulty identifying and measuring appropriate clinical endpoints," said Joseph A. DiMasi, director of economic analysis at Tufts CSDD.

Despite lengthier than average clinical development and approval phase times, the CNS share of new drug approvals in the U.S. since the 1980s has remained relatively steady, ranging from 10% to 12% on a decade-by-decade basis.

During 2000-17, the U.S. Food and Drug Administration approved 509 new drugs and biologics, of which 57 were CNS drugs. DiMasi noted that demand for new CNS drugs will continue to remain strong, and likely grow, as CNS disorders are expected to constitute nearly 15% of the global disease burden by 2020.

"The principal challenge for drug developers is to decrease development time for CNS drugs and increase success rates without sacrificing safety, while simultaneously reigning in overall development costs," DiMasi said.

Other key study findings, summarized in the September/October Tufts CSDD Impact Report, released today, included the following:

  • Mean total phase time (sum of clinical and approval phase lengths) for CNS drugs during 2000-17 ranged from 8.2 years for anti-psychotics to 12.6 years for multiple sclerosis treatments.

  • The most prevalent disease areas among CNS drug approvals during 2000-17 were epilepsy and psychosis, each receiving 10 approvals.

  • The share of CNS approvals that received a priority rating more than doubled over the study period, from 18.8% for 2000-05 to 39.1% for 2012-17.

ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Established in 1976, the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) is a multidisciplinary, academic research group that provides data-driven analyses and strategic insight to help developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers CME-accredited professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bimonthly newsletter focusing on critical drug development issues.

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Contacts:  Tufts Center for the Study of Drug Development

                  Rachel Stanton– 617-636-2170

                  Rachel.Stanton@tufts.edu

                  Business Communication Strategies

                  Peter Lowy – 617-734-9980

                  lowy@bus-com.com

PRESS RELEASE: Tufts CSDD Impact Report July/August 2018, Vol. 20 No.4, Available Now

FOR IMMEDIATE RELEASE

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Rising Protocol Complexity Is Hindering Performance while Driving Up Cost of Clinical Trials, According to the Tufts Center for the Study of Drug Development

BOSTON – July 17, 2018 – Rising protocol complexity is hindering clinical trial performance and efficiency, and helping to drive up the cost of developing new drugs, according to a recently completed analysis by the Tufts Center for the Study of Drug Development.

"Protocol design scope and complexity have steadily increased, and this trend will continue—and likely accelerate—as pharmaceutical and biotechnology companies target more difficult-to-treat and rare diseases, enroll more stratified patient populations, and collect higher volume and more diverse data," said Ken Getz, associate professor and director of sponsored research at Tufts CSDD, who led the analysis.

He said that in addition to increasing clinical costs and inefficiencies, current protocol design practices increase the burden on internal and external staff to execute trials and hinder study volunteer recruitment and retention rates.

The analysis was based on an assessment of 9,737 protocols from 178 global pharmaceutical and biotechnology companies.

Key findings stemming from the study, summarized in the July/August Tufts CSDD Impact Report, released today, included the following:

  • Phase I and II clinical trials are the most complex, based on numbers of distinct and total procedures, whereas Phase III trials have seen the highest increase in complexity during the past 10 years.
  • The total number of endpoints rose 86%, between 2001-05 and 2011-15, and procedures supporting these endpoints contributed a much higher proportion of data informing secondary supplementary, tertiary, and exploratory endpoints.
  • From 2001-05 to 2011-15, drug makers doubled the number of countries and increased the number of investigative sites by 63% to support Phase III protocols, as the mean number of patients declined 18%.
  • Over the next three years, companies expect electronic case report form data in the primary electronic data capture to decline as a share of all data collected to support protocol endpoints, highlighting the growing challenge of data coordination and integration.

ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Established in 1976, the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) is a multidisciplinary, academic research group that provides data-driven analyses and strategic insight to help developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers CME-accredited professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bimonthly newsletter focusing on critical drug development issues.

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Contacts:  Tufts Center for the Study of Drug Development

                  Rachel Stanton– 617-636-2170

                  Rachel.Stanton@tufts.edu

                  Business Communication Strategies

                  Peter Lowy – 617-734-9980

                  lowy@bus-com.com

PRESS RELEASE: Tufts CSDD Impact Report May/June 2018, Volume 20 No. 3, Available Now

Patent-to-Launch Time for Orphan Drugs is 2.3 Years Longer vs. Other Drugs, According to the Tufts Center for the Study of Drug Development

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BOSTON – May 9, 2018 – Orphan drug development, which faces special challenges in recruiting sufficient numbers of patients for clinical trials, on average takes 15.1 years to go from first patent filing to product launch, 18% longer than the average time required for all new drugs, according to a study recently completed by the Tufts Center for the Study of Drug Development.

The study, which examined 46 first-in-class, orphan new molecular entities approved by the United States Food and Drug Administration (FDA) between 1999 and 2012, found that development time for drugs to treat ultra-orphans diseases—those in the U.S. that only affect up to a few hundred patients—is even longer: 17.2 years.

Orphan drugs are defined as prescription medicines developed for rare diseases and conditions, which, in the U.S., affect fewer than 200,000 people, or, in the European Union, affect 5 per 10,000 people or fewer. Orphan diseases currently encompass more than 7,000 diseases and conditions, affecting up to 30 million people in the U.S., 50% of whom are children.

"Creating new medicines to treat orphan diseases continues to pose unique challenges, not the least of which is the logistical difficulty of working with small patient populations that are, in the vast majority of cases, widely geographically dispersed," said Christopher-Paul Milne, research associate professor and director of research at Tufts CSDD at Tufts University School of Medicine, who conducted the analysis.

He noted while new approaches to study design, including use of patient advocacy groups and adaptive clinical trials, are helping to mitigate development problems, orphan drug development is likely to continue to face difficulty due, in part, to a lack of animal models and biomarkers.

The analysis, summarized in the May/June Tufts CSDD Impact Report, released today, also found that:

  • Designations and approvals for orphan oncology drugs outpaced orphan drug development in all other therapeutic areas.
  • Orphan drug developers encountered an average of 4.2 special challenges in the course of research and development conducted during 1999-12.
  • Orphan drugs focused on central nervous system or cardiovascular indications experienced the greatest number of development challenges.

ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Established in 1976, the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) is a multidisciplinary academic research group that provides data-driven analyses and strategic insight to help developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers CME-accredited professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bimonthly newsletter focusing on critical drug development issues.

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Contacts:    Tufts Center for the Study of Drug Development

                  Lea Karnath – 617-636- 0840

                  Leanora.Karnath@tufts.edu

 

                  Business Communication Strategies

                  Peter Lowy – 617-734-9980

                  lowy@bus-com.com

PRESS RELEASE: Tufts CSDD Impact Report March/April 2018, Volume 20 No. 2, Available Now

First Comprehensive Clinical Site Initiation Benchmark, Developed by Tufts CSDD, Finds Study Startup Is Lengthy and Inefficient

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FOR IMMEDIATE RELEASE

BOSTON – March 7, 2018 – The clinical site initiation process—time needed to identify and select sites and begin studies—takes an average of nearly eight months, longer than it did a decade ago, and remains inefficient, according to a study recently completed by the Tufts Center for the Study of Drug Development.

Total duration from site identification to study start-up completion is 31.4 weeks, one month longer than the average duration observed 10 years ago.

The finding, based on a global survey of drug sponsors and contract research organizations, is the first study to comprehensively benchmark site identification, site selection, and start-up cycle times for repeat and new investigative sites for Phase II and III clinical studies.

"Although the biopharma industry has implemented new technology solutions and practices to shorten the study initiation process, it remains highly inefficient with wide variation between companies," said Mary Jo Lamberti, senior research fellow at Tufts CSDD, who led the analysis. "Overall, a high percentage of sites under-enroll, and one in 10 sites are never activated, which reflects that process improvements have not been made."

The analysis, summarized in the March/April Tufts CSDD Impact Report, released today, also found that:

  •  28% of engaged investigative sites are new relationships with no prior history or familiarity of working with a CRO or sponsor, a proportion that is expected to increase as more clinical trials focus on rare diseases and highly targeted patient sub-populations.
  •  The overall site initiation cycle time is 9.9 weeks shorter for repeat or familiar sites, compared to new sites.
  •  CROs, compared to sponsors, complete the site initiation process an average of 5.6 weeks faster for repeat sites and an average of 11 weeks faster for new sites.
  •  30% – 40% of sponsors and CROs report they are somewhat or completely unsatisfied with their site initiation processes.

ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Established in 1976, the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) is a multidisciplinary academic research group that provides data-driven analyses and strategic insight to help developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers CME-accredited professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bimonthly newsletter focusing on critical drug development issues.

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Contacts:   

Tufts Center for the Study of Drug Development
Lea Karnath – 617-636- 0840
Leanora.Karnath@tufts.edu

Business Communication Strategies
Peter Lowy – 617-734-9980
lowy@bus-com.com

 

TUFTS CSDD R&D COST STUDY - March 2016

Tufts CSDD R&D Cost Study

March 9, 2016: The R&D cost study has been published online in the Journal of Health Economics and will be available in print in May 2016. The citation for the journal article is as follows:

DiMasi JA, Grabowski HG, Hansen RA. Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics 2016;47:20-33.


March 2, 2015: On February 3, 2015, Dr. Joseph DiMasi, lead economist for the Tufts Center for the Study of Drug Development's (CSDD) recently released study results on the R&D costs of new drug development, received a letter from the Union for Affordable Cancer Treatment (UACT) posing a series of questions about the study. The UACT letter, as well as Dr. DiMasi’s detailed response, are posted here.

Tufts CSDD remains committed to responding to questions about our cost study’s methodology and findings, and we welcome the opportunity to engage in a productive dialogue with all interested stakeholders regarding the study’s implications. 

To view the letters, see the following links:

November 18, 2014: Cost Study Press Event Webcast:

Tufts CSDD recently hosted a briefing on Nov. 18, 2014 to present results of its latest study, updating the total average cost of developing and winning market approval for a new prescription drug. The following documents related to the study are available for download: