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, T
'/>"/>

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:12/20/2014)... LunaDress has recently announced its 2015 collection of ... on all of its special occasion dresses & wedding apparel. ... wedding gown. If you have no idea of what to ... different wedding dress styles and our dress experts are here ... current special offer, up to 80% off," the CEO of ...
(Date:12/20/2014)... 20, 2014 Recently, VogueQueen.com, a leading ... VogueQueen Big Sale Online for 2015. Great discounts ... new and old consumers can get a discount, up ... the company’s website before January 30, 2015. , VogueQueen.com ... and launched a prom dress promotion. Many customers worldwide ...
(Date:12/20/2014)... Francisco, CA (PRWEB) December 20, 2014 ... Social Innovation company just launched first birthday focused portal ... services, “MERRY BIRTHDAY MESSAGE” launched in both US and ... MERRY BIRTHDAY MESSAGE : http://merrybirthday.net/message/ , MERRY ... for everyone’s birthday around the world. , Features, Choose ...
(Date:12/20/2014)... 2014 Xarelto bleeding lawsuits filed ... uncontrollable bleeding and other serious side effects will be ... Louisiana for coordinated pretrial proceedings, Wright & Schulte LLC ... issued an order Friday to transfer 21 Xarelto lawsuits ... federal courts to the Louisiana district court for coordination ...
(Date:12/19/2014)... 20, 2014 Today, Balfleet.com , ... outfits, announces its formal dress promotion. All the old ... to 60% off. , Balfleet.com is well-known for its ... dresses, prom dresses, cocktail dresses and more. Its formal ... money-back guarantee, and they can create an elegant look ...
Breaking Medicine News(10 mins):Health News:2015 Collection of Wedding Dresses from LunaDress Online on Sale Now 2Health News:VogueQueen Big Sale Online For The Coming 2015 2Health News:Atore, Inc. Releasing the First Birthday Portal 2Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 2Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 3Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 4Health News:Balfleet.com Announces Its Formal Dress Promotion For 2015 2
... TAMPA, Fla. -- Alexander R. A. Anderson, Ph.D., co-director ... and his colleagues, Simon Hayward, Ph.D., at Vanderbilt University ... have received a five-year, $3 million grant from the ... to predict prostate cancer aggressiveness. "Mathematical models have ...
... HealthDay Reporter , THURSDAY, Oct. 20 (HealthDay News) -- The ... worry about an increased risk of brain cancer, new Danish research ... subject finds no more brain tumors among people who had cell ... phones. Although no one study can rule out harm with ...
... HealthDay Reporter , FRIDAY, Oct. 21 (HealthDay News) ... hormone production as the testes and adrenal glands. But those ... new study, showing hormone production in the penis itself, turn ... in both mice and human tissue, revealing that proteins key ...
... new development paths towards a healthier life. New opportunities ... development, industrial biotechnology and environmental technology have been a ... , VTT is one of the organisers of Metabomeeting ... at the end of September. Professor Jeremy K. Nicholson ...
... scientists advances a strategy for taming the side effects ... medications that work by disrupting the activity of certain ... developed at St. Jude. In this study, scientists showed ... activity of genes in a cell signaling pathway regulated ...
... over the years has made it possible for researchers and ... using ionising radiation, for example X-rays. The images ... of water in the body, since the body is largely ... nuclei in water molecules. It can also be used to ...
Cached Medicine News:Health News:Researchers get $3 million National Institutes of Health grant for mathematical models of prostate cancer aggressiveness 2Health News:Cell Phones Don't Raise Brain Cancer Risk, Study Says 2Health News:Cell Phones Don't Raise Brain Cancer Risk, Study Says 3Health News:Research Suggests Penis Might Produce Testosterone 2Health News:Research involving thyroid hormone lays foundation for more targeted drug development 2Health News:Research involving thyroid hormone lays foundation for more targeted drug development 3Health News:New instrument helps researchers see how diseases start and develop in minute detail 2
(Date:12/19/2014)... and CARDIFF-BY-THE-SEA, Calif. , Dec. ... SRNE ;  Sorrento), an oncology company developing ... Conkwest, Inc., a privately-held immuno-oncology company developing proprietary ... cell-line based therapy, announced today that the companies ... develop next generation CAR-TNK™ (pronounced as "Car-Tank") immunotherapies ...
(Date:12/19/2014)... LOS ALTOS, Calif. , Dec. 18, 2014 ... of a new generation of equipment for the ... today the release of the new Luminary™ Profiler, ... highly accurate light-based measurement in a cost-effective, portable ... to meet the specific needs of the cannabis ...
(Date:12/19/2014)... Dec. 18, 2014 Baptist Health Lexington is the ... to receive full Atrial Fibrillation with Electrophysiology Services (EPS) Accreditation ... Atrial fibrillation is the most common cardiac arrhythmia and ... cases can lead to stroke and possible death. More than ... have atrial fibrillation and the numbers are rapidly increasing ...
Breaking Medicine Technology:Sorrento and Conkwest Announce Exclusive Global Collaboration 2Sorrento and Conkwest Announce Exclusive Global Collaboration 3Sorrento and Conkwest Announce Exclusive Global Collaboration 4Sorrento and Conkwest Announce Exclusive Global Collaboration 5Sage Analytics Develops Breakthrough System for Potency Testing of Cannabis Products 2Baptist Health Lexington First in the Nation to Receive Atrial Fibrillation with EPS Accreditation 2Baptist Health Lexington First in the Nation to Receive Atrial Fibrillation with EPS Accreditation 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: