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

BOSTON (March 19, 2014) Experts across academia, industry and government propose a new method for health care providers to get the right treatments to the right patients at the right time. This new approach, A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials, published in Nature Clinical Pharmacology & Therapeutics, recommends a seamless transition from controlled experiments to real-world comparative effectiveness trials. This continuum will improve the accuracy of treatment selection and better determine how those treatments work on different groups of people.

Efficacy trials are conducted in optimal conditions with patients who have similar characteristics. These trials are typically used to secure regulatory approval for a drug.

Effectiveness trials are conducted in more typical clinical settings, with patients who have varying characteristics. These trials are designed to determine whether treatment effects identified in efficacy trials carry over to more typical uses of drugs in practice.

Currently, efficacy and effectiveness trials are conducted separately, and effectiveness trials may occur years later or not at all. In the E2E model, an effectiveness trial starts immediately after the efficacy trial is completed (or as soon as possible, depending upon a predetermined approval process). Data derived from the efficacy trial can be used to formulate questions to investigate during the effectiveness trial; data derived from the effectiveness trial can then be used to assist patients and providers in making individual treatment decisions.

Development of the E2E approach was led by Harry P. Selker, MD, MSPH of Tufts Clinical and Translational Science Institute (CTSI) and Tufts Medical Center's Institute for Clinical Research and Health Policy Studies (ICRHPS), with assistance from Aaron Kirby, MSc, Tufts 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 learning opportunity will require pre-planned and cost-effective studies: the E2E trial may be exactly what's needed."

The authors hope practitioners will consider the E2E model for future trials.


'/>"/>

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

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:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... Aliso Viejo, California (PRWEB) , ... June 25, 2016 , ... ... preset to fit their specific project," said Christina Austin - CEO of Pixel Film ... all fully customizable and all within Final Cut Pro X . Simply select ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
(Date:6/24/2016)... Research and Markets has announced the addition of ... report to their offering. ... The World Market for Companion Diagnostics covers the world market ... the report includes the following: , World ... Region (N. America, EU, ROW), 2015-2020 , World IVD ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, ... less invasive and more durable cerebrospinal fluid treatments, ... funding.  The Series-A funding is led by Innova ... Fund, and other private investors.  Arkis, new financing ... instrumentation and the market release of its in-licensed ...
Breaking Medicine Technology: