Navigation Links
U-M Receives NIH, FDA Grant To Study Adaptive Clinical Trial Design
Date:10/7/2010

usually only triggered when an overwhelming effect is seen.

Adaptive clinical trials can more seamlessly make use of accumulating information using Bayesian statistics – which allow data analysts to predict trial success based on early patient responses and other accumulating information.

"Adaptive design essentially allows the statisticians to continuously reanalyze the data over the entire study and we can end up changing how patients are assigned within the study if it really looks like it's working," says Barsan, who is also principal investigator of the clinical trials coordinating center of the Neurological Emergencies Treatment Trials Network. "We believe this is one way to avoid getting false negatives and it's better protection for patients which is really important."

The three-year project, "Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design," is one of four recipients of a $9.4 million award by the National Institutes of Health-Food and Drug Administration Joint Leadership Council to spearhead collaborative activities to stimulate a new research in regulatory science.

The project is led by Barsan, Donald A. Berry, Ph.D., senior statistical scientist and founder of Berry Consultants, and Roger J. Lewis, M.D., Ph.D., co-chair of the Regulatory and Ethics Knowledge and Research Program and professor of emergency medicine at the University of California –Los Angeles.

The objective of the grant is to "optimize the design of four large, neurological emergency trials at various stages of development," Barsan says. "We'll use modeling and mathematical simulation to really kick the tires on a number of potential adaptive designs with the hope of gaining efficiency in the ultimate trial design. Hopefully it will lead to considerable savings in the research process and allow us to more accurately and rapidly identify treatments which improve patient outcomes."


'/>"/>
SOURCE University of Michigan Health System
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2014)... JERUSALEM , August 19, 2014 ... http://www.oramed.com ), a clinical-stage pharmaceutical company focused on ... today that the Intellectual Property Department of ... patent for its invention, titled "Methods and Compositions ... Oramed Pharmaceuticals  Oramed Pharmaceuticals is a ...
(Date:8/19/2014)... MENLO PARK, Calif. , Aug. 19, 2014 /PRNewswire/ ... announced today a protocol amendment to allow for expanded dosing ... U.S. Food and Drug Administration (FDA) and that a new ... at three clinical trial sites in the United ... of US$2.9 million have been raised through warrant exercise in ...
(Date:8/19/2014)... ,Weight Loss- Market Analysis, Global API Manufacturers ... insights about phase III pipeline drugs and marketed drugs ... is to establish the understanding for API Manufacturers for ... countries and regions. While the leading brands, companies and ... on the drug master filings across the US, ...
Breaking Medicine Technology:Oramed Granted Patent in Spain for Oral Administration of Insulin 2Oramed Granted Patent in Spain for Oral Administration of Insulin 3DelMar Pharmaceuticals Provides Update on Glioblastoma Clinical Trial and Results of Warrant Tender Offer 2DelMar Pharmaceuticals Provides Update on Glioblastoma Clinical Trial and Results of Warrant Tender Offer 3DelMar Pharmaceuticals Provides Update on Glioblastoma Clinical Trial and Results of Warrant Tender Offer 4DelMar Pharmaceuticals Provides Update on Glioblastoma Clinical Trial and Results of Warrant Tender Offer 5DelMar Pharmaceuticals Provides Update on Glioblastoma Clinical Trial and Results of Warrant Tender Offer 6DelMar Pharmaceuticals Provides Update on Glioblastoma Clinical Trial and Results of Warrant Tender Offer 7Weight Loss Market Analysis, Global API Manufacturers and Phase III Pipeline Assessment, 2014 2Weight Loss Market Analysis, Global API Manufacturers and Phase III Pipeline Assessment, 2014 3Weight Loss Market Analysis, Global API Manufacturers and Phase III Pipeline Assessment, 2014 4
... -- Biostar,Pharmaceuticals, Inc. (OTC Bulletin Board: BSPM) ("Biostar" or "the Company"),a Xianyang-based developer, manufacturer ... announced financial results the third quarter ended September 30, 2009. , , ... ... Q3 2008 ...
... TRIANGLE PARK, N.C., Nov. 12 Chimerix, Inc., ... address life-threatening diseases, announced today that Kenneth I. ... overview at two upcoming investor conferences. Mr. ... pipeline, including CMX001, a broad-spectrum antiviral being developed ...
Cached Medicine Technology:Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 2Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 3Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 4Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 5Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 6Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 7Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 8Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 9Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 10Biostar Pharmaceuticals, Inc. Announces Record Third Quarter 2009 Financial Results 11Chimerix to Present at Two Upcoming Investor Conferences 2
(Date:8/20/2014)... “Have you recently been involved in an auto ... lawyer serving the greater Seattle area. “Are you still feeling ... keep reading . , In a recently released article, Dax ... accident can use to see if they may qualify for ... insurance claim will allow an individual to receive medical treatment ...
(Date:8/20/2014)... August 20, 2014 Low market concentration, ... availability of substitutes typify the market for packaging design ... 3.1 out of 5, indicating a moderate level of ... and suppliers have an equal amount of leverage during ... , First, few substitutes exist for packaging design ...
(Date:8/20/2014)... First Choice Emergency Room , the ... United States, named Richard Daniels, DO the Medical Director ... , “We are pleased to announce that Dr. Daniels ... facility in Pflugerville,” said Dr. James M. Muzzarelli, Executive ... Dr. Daniels received his undergraduate degree from Brigham Young ...
(Date:8/20/2014)... 2014 Kowa Optimed returns after a ... debut the new SL-17 portable slit lamp. , The ... LED source controlled by an illuminated thumb wheel for ... uses commercially available AAA rechargeable and dry cell batteries, ... requiring batteries designed specifically for the device. The new ...
(Date:8/20/2014)... (PRWEB) August 20, 2014 This ... line of software defined networking, high availability cloud ... portfolio of Resellers, while allowing OPEN-V to sell ... is pleased to work with OPEN-V on this ... Donald Hows, manager distribution channels at storageFOUNDRY. "Nautilus ...
Breaking Medicine News(10 mins):Health News:Five Questions to Determine Who Qualifies for a Personal Injury Claim Recently Released by The Jones Firm in Recent Article 2Health News:Packaging Design Services Procurement Category Market Research Report Now Available from IBISWorld 2Health News:Packaging Design Services Procurement Category Market Research Report Now Available from IBISWorld 3Health News:Packaging Design Services Procurement Category Market Research Report Now Available from IBISWorld 4Health News:First Choice Emergency Room Announces Dr. Richard Daniels as Medical Director of the Pflugerville – FM 685 Facility 2Health News:Kowa Optimed (Booth MS13043) to Debut New Portable Slit Lamp at 2014 Vision Expo West in Las Vegas, Nevada 2Health News:storageFOUNDRY and Open-V OzoneStack Announce Bilateral Distribution Agreement 2Health News:storageFOUNDRY and Open-V OzoneStack Announce Bilateral Distribution Agreement 3
... , TUESDAY, Oct. 11 (HealthDay News) -- A small, preliminary study ... intestines -- a potential sign that the pills might reduce the ... be done, and the researchers aren,t yet recommending that people head ... meal times. "If you want to add ginger to part ...
... Goodwin HealthDay Reporter , TUESDAY, Oct. 11 (HealthDay ... raises the risk for both breast and ovarian cancer are ... new study indicates. Those other women include both women ... of breast and ovarian cancer, and women without ...
... A team of scientists led by a Penn State ... an alternative method of molecular depth profiling -- a ... such as human tissue, nanoparticles, and other substances. In ... modeling to show the effectiveness and limitations of the ...
... is exploring the ethical challenges that clinicians and ... in the United States. The project is supported by ... Program. Most of the estimated 11 million undocumented ... are ineligible for public insurance programs. They are prohibited ...
... intersection density and well-connected streets in towns and cities ... according to a Queen,s University study. "We,ve known ... a high density of intersections in a given areahelps ... and more efficient for them to walk to work ...
... TUESDAY, Oct. 11 (HealthDay News) -- Nearly 90 percent of ... well-being, according to a new national poll of 1,000 voters. ... also revealed that by having routine mammograms, women gain a ... that poll results show that nearly nine in 10 women ...
Cached Medicine News:Health News:Ginger Supplements Might Ease Inflammation Linked to Colon Cancer 2Health News:Mutant Gene That Ups Risk for Ovarian Cancer May Aid Survival 2Health News:Mutant Gene That Ups Risk for Ovarian Cancer May Aid Survival 3Health News:Mutant Gene That Ups Risk for Ovarian Cancer May Aid Survival 4Health News:Molecular depth profiling modeled using buckyballs and low-energy argon 2Health News:Molecular depth profiling modeled using buckyballs and low-energy argon 3Health News:New project examines medical safety net for undocumented patients 2Health News:Women Say Mammograms Give Them Sense of Control: Survey 2
... MJS anatomic knee ... enhance durability, minimize polyethylene ... surfaces, to minimize contact ... and to achieve a ...
Simplified Design-Based on 15 Years of Experience...
... The result of more than a ... is based on a comprehensive study of ... resection, and tibial insert retrieval analysis.,As a ... axial rotation and motion patterns in total ...
... True to its leadership role within ... the clinical experience of the industry's leading ... Platform Knee System, with the clinically proven ... world's leading rotating platform knee. ,The result ...
Medicine Products: