Navigation Links
Multidisciplinary research team led by Tufts CTSI proposes new model for clinical trials
Date:3/19/2014

ufts CTSI's Manager of Project Administration. The research team includes:

  • Kenneth A. Oye, PhD, Massachusetts Institute of Technology (MIT)
  • Hans-Georg Eichler, MD, MSc, European Medicines Agency
  • Norman L. Stockbridge, MD, PhD, US Food and Drug Administration, Center for Drug Evaluation and Research
  • Cyrus R. Mehta, PhD, Harvard School of Public Health
  • Kenneth I. Kaitin, PhD, Tufts Center for the Study of Drug Development
  • Newell McElwee, PharmD, MSPH, Merck & Co.
  • Peter K. Honig, MD, MPH, AstraZeneca
  • John K. Erban, MD, Tufts Cancer Center
  • Ralph B. D'Agostino, PhD, Boston University; Harvard Clinical Research Institute

"The E2E approach represents a fundamental shift in a drug development model that has remained basically unchanged for over fifty years," suggests Kenneth I. Kaitin, PhD, director of the Tufts Center for the Study of Drug Development and research professor at Tufts University School of Medicine. "Although adoption of the approach is not without its challenges, there are likely to be many winners: industry, who will gain better understanding of a drug's utility, enabling differentiation from competitors; regulators, who will have greater understanding of the drug's safe and effective use in heterogeneous populations; payers, who will be able to make more informed reimbursement and coverage decisions; and of course physicians and patients, who will benefit from real-world data on the benefits and risks of new medicines."

"There is growing realization that the difference between efficacy and effectiveness is not just a challenge for drug regulation, but also an underutilised learning opportunity," says Hans-Georg Eichler, MD, MSc, of European Medicines Agency, "the heterogeneity of real-life treatment populations may help identify non-responders or non-tolerators, and such insights may not be gained from the rather homogenous clinical trial populations. Realizing this learn
'/>"/>

Contact: Amy West
awest@tuftsmedicalcenter.org
617-636-6025
Tufts Clinical and Translational Science Institute
Source:Eurekalert

Page: 1 2 3

Related medicine news :

1. Multidisciplinary teams helped marathon bombing survivors rebuild their lives
2. Wayne State awards $1.8 million to enhance multidisciplinary research
3. Multidisciplinary initiative reduces airway infection in pediatric intensive care patients
4. Ottawa researchers find new pathway connected to type 2 diabetes
5. Shoulder revision repair surgery not as successful 2 years later, say researchers
6. Researchers find significant increase in painkillers prescribed to US adults in the ER
7. Dartmouth researchers develop new approach to chronic lymphocytic leukemia treatment
8. New stroke research combines brain stimulation, gait training
9. MD Anderson honors 2 champions for women in medicine and research
10. Innovative gaming research gains national recognition
11. Researchers destroy cancer with cryoablation & nanoparticle-encapsulated anticancer drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... 2014 Advancements in ultrasound technologies ... applications due to their cost-effectiveness, non-invasiveness, and absence ... ultrasound, such as the evolution of wireless transducers ... the market moving throughout 2014 and beyond. Such ... not only the point-of-care (POC) testing in hospital ...
(Date:8/22/2014)... Eagerly embracing intended parents around the globe, ... offers the top male infertility programs — run by ... network of IVFinMexico.com continues to shape modern ... female and male infertility, advanced research and education. , ... eminently set by company CEO and Founder Tolga Umar ...
(Date:8/22/2014)... August 22, 2014 CarePoint Health ... in Internal Medicine, Geriatrics, Hospice and Palliative Care, ... Health Medical Group. Their system welcomes Dr. Reisner ... experienced physicians comprise CarePoint Health Medical Group, a ... Hudson County, representing a wide range of specialties. ...
(Date:8/22/2014)... An intensive effort to sterilize feral cats reduced the number ... euthanized, a new study reveals. "We investigated whether we ... animal control," Dr. Julie Levy, a professor of shelter medicine ... in a university news release. "Neutering a few ... explained, "so we wanted to pick a focused area and ...
(Date:8/22/2014)... 22, 2014. A new study of self-awareness ... multiple sclerosis (MS) may be able to improve ... was epublished ahead of print on July 2 ... Hali Griswold, Nancy D. Chiaravalloti & John DeLuca: ... multiple sclerosis doi: 10.3233/NRE-141113). Self-awareness is one,s ability ...
Breaking Medicine News(10 mins):Health News:Global Top Ultrasound Market Suppliers Assessed in New VPG Research Report Available at MarketPublishers.com 2Health News:Global Top Ultrasound Market Suppliers Assessed in New VPG Research Report Available at MarketPublishers.com 3Health News:Mexico Now Offers Top Program for Couples Suffering from Male Infertility 2Health News:Mexico Now Offers Top Program for Couples Suffering from Male Infertility 3Health News:Mexico Now Offers Top Program for Couples Suffering from Male Infertility 4Health News:Dr. Reisner Joins CarePoint Health Medical Group 2Health News:Neutering Project Curbed Feral Cat Population 2Health News:Kessler Foundation study of self-awareness in MS has implications for rehabilitation 2
... as ,Natural, and ,Organic, Should Still Have Cancer Warning , ... Friday, March 6, 2009 a follow-up study on 1,4-dioxane contamination ... (OCA) , a watchdog group with over 500,000 members, and ... (author of The Safe Shopper,s Bible ), ...
... Public Policy & Aging Report (PPAR) ... These include deductions, exemptions, deferrals, and circuit breakers, most ... particular relevance as President Barack Obama prepares a plan ... and older who earn less than $50,000. , "In ...
... 27 Orthopaedic surgeon Thomas C. Barber, MD, was ... (BOC)( http://www3.aaos.org/member/bdcounc/bocinfo.cfm ) of the American Academy ... the 2009 Annual Meeting at the Venetian Sands Expo ... on the Academy,s Board of Directors. The BOC ...
... VEGAS, Feb. 27 Orthopaedic surgeon David Polly ... Societies (BOS), of the American Academy of Orthopaedic Surgeons ... Dr. Polly will also sit on the Academy,s Board ... the Department of Orthopaedic Surgery at the University of ...
... BIRMINGHAM, Ala., Feb. 27 HealthSouth Corporation (NYSE: ... released by the Office of Management and Budget on February ... HealthSouth has been a leader in advocating ... care system and the inefficiencies created by those barriers, so ...
... Celebrities and Hollywood elite celebrated the launch of ... Biomedical Skin Treatments ... Garth Fisher and beauty industry veteran Paul Scott ... in the heart of Los Angeles. (Photo: ...
Cached Medicine News:Health News:Follow-Up Tests of Leading Personal Care and Household Cleaning Brands Reveal Significant Improvements in Levels of Carcinogenic 1,4-dioxane 2Health News:Thomas C. Barber, MD, Elected Chair of Academy Board of Councilors 2Health News:Thomas C. Barber, MD, Elected Chair of Academy Board of Councilors 3Health News:David W. Polly Jr., MD, Elected Secretary of Academy Board of Specialty Societies 2Health News:HealthSouth Issues Preliminary Comments on the President's Healthcare Budget Proposal and Announces Plans to Host a Conference Call 2Health News:Kim Kardashian and Tia Carrere Celebrate Premiere of Revolutionary CellCeuticals(R) Biomedical Skin Treatments at Social Hollywood with Founders Dr. Garth Fisher and Paul Scott Premo 2Health News:Kim Kardashian and Tia Carrere Celebrate Premiere of Revolutionary CellCeuticals(R) Biomedical Skin Treatments at Social Hollywood with Founders Dr. Garth Fisher and Paul Scott Premo 3
(Date:8/22/2014)... August 22, 2014 ... the addition of the  "Global Operating Room ...      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ,An ... sterile environment in a healthcare facility used ... with technically advanced equipment, which ensures patient ...
(Date:8/22/2014)... HILL, N.C. , Aug. 22, 2014  As ... the healthcare sector, many leaders in this area are ... The Medical Affairs Consortium at Best ... a forum for sharing insights about the key challenges ... creating and sharing solutions through three virtual roundtable discussions ...
(Date:8/22/2014)...  Dr. Mark Rasak , MD is recognized ... Award in the field of Medicine as a result ... Dr. Rasak has over 15 years of ... the business; overseeing the daily operations; interventional cardiology; complex ... addition, he is an honored Fellow of the American ...
Breaking Medicine Technology:Global Operating Room Equipment Market 2014-2018: Key Vendors are Getinge, STERIS, Stykron and TRUMPF Medical Systems 2Best Practices' Medical Affairs Consortium Survey Has Achieved Strong Participation 2Dr. Mark Rasak, MD is recognized by Continental Who's Who with the Diamond Lifetime Achievement Award 2
... DALLAS, October 28, 2011   ... Analysis and Forecasts to 2020, to its store. This ... US. In addition, it covers detailed clinical assessment of ... analysis of sales performance during the forecast period (2016-2020). ...
... Publicis Groupe announced today that Digitas Health and ... (PHCG), powerfully redefining Publicis Groupe,s client offering to ... PHCG is the world,s leading healthcare communications ... Razorfish Health -- Publicis Groupe,s largest digital agencies ...
Cached Medicine Technology:ReportsnReports - Hyper Acute Pancreas (Pancreatic Cancer) - Analysis and Forecasts to 2020 2ReportsnReports - Hyper Acute Pancreas (Pancreatic Cancer) - Analysis and Forecasts to 2020 3ReportsnReports - Hyper Acute Pancreas (Pancreatic Cancer) - Analysis and Forecasts to 2020 4Publicis Healthcare Communications Group Redefines Publicis Groupe's Healthcare Client Offering by Joining Forces with Digitas Health and Razorfish Health 2Publicis Healthcare Communications Group Redefines Publicis Groupe's Healthcare Client Offering by Joining Forces with Digitas Health and Razorfish Health 3Publicis Healthcare Communications Group Redefines Publicis Groupe's Healthcare Client Offering by Joining Forces with Digitas Health and Razorfish Health 4Publicis Healthcare Communications Group Redefines Publicis Groupe's Healthcare Client Offering by Joining Forces with Digitas Health and Razorfish Health 5
... Hema-G Stains for Geometric Data ... performance. Stains are quality control ... to ensure proper staining and ... most applications for a minimum ...
Wright Stain Solutions...
... single-solution staining, Hema-Quik for Wright ... stain solution for five to ... water for five to fifteen ... by dipping quickly in deionized ...
This stain is the McNeal formula and can be substituted for Wright Stain solution....
Medicine Products: