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

ANN ARBOR, Mich., Oct. 7 /PRNewswire-USNewswire/ -- Clinical trials in which participants are randomly assigned to different treatments by design are the cornerstone of clinical research. When conducted correctly, it's widely accepted by the research community that the results are valid and can be trusted.  

But researchers at the University of Michigan hope to improve the process for bringing therapies and medical devices to patients by investigating the impact of a class of innovative trial designs known as adaptive clinical trials – which make adjustments to the trial using information accumulated as patients are enrolled – in hopes of improving the efficiency of clinical trials as a whole.

"One of the hard and firm rules of randomized clinical trials, and for good reason, is you can't just go changing your trial to get the results you want," says William Barsan, M.D., chair and director of the U-M Department of Emergency Medicine.  "But with adaptive clinical trials, you spend a lot of time up-front asking yourself, 'What if?' so that any changes made throughout the course of the study are all agreed upon at the beginning, written into the study design and only changed throughout the course of the study based on pre-specified rules."

Researchers cannot always predict at what point a specific drug or treatment will show therapeutic results during the course of the study, if at all. Once a standard trial is underway, trial characteristics such as inclusion criteria cannot be modified or changed even if a sufficient amount of data collected before the trials end-date demonstrates that such changes may be necessary.

For example, remaining patients who are randomized to the placebo group cannot benefit from the therapeutic effect of the treatment, and money will continue to be spent until the trial ends. Current trials often include periodic review of data to search for early benefit or early harm but changes are
'/>"/>

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:1/15/2014)... is very pleased to announce the appointment of Mr. ... Mark was promoted from his current role of Chief Operating ... in Massachusetts , Mississippi ... 2012 with 20+ years of broad-based operations, sales, engineering and ...
(Date:1/15/2014)... Jan. 15, 2014 Reportlinker.com announces that ... in its catalogue: ... Analysis http://www.reportlinker.com/p01957812/Insulin-Pump-Market--Forecast-–-Worldwide-Analysis.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Equipment_and_Supply ... Insulin Pumps are gaining ...
(Date:1/15/2014)... , Jan. 15, 2014  Zafgen, Inc., a leading ... of severely obese patients, today announced initial results ... selective inhibitor of methionine aminopeptidase 2 (MetAP2), in ... of genetic obesity.  These results showed improvements in ...
Breaking Medicine Technology:Tegra Medical Appoints New Chief Executive Officer 2Tegra Medical Appoints New Chief Executive Officer 3Insulin Pump Market & Forecast - Worldwide Analysis 2Insulin Pump Market & Forecast - Worldwide Analysis 3Insulin Pump Market & Forecast - Worldwide Analysis 4Insulin Pump Market & Forecast - Worldwide Analysis 5Insulin Pump Market & Forecast - Worldwide Analysis 6Insulin Pump Market & Forecast - Worldwide Analysis 7Insulin Pump Market & Forecast - Worldwide Analysis 8Insulin Pump Market & Forecast - Worldwide Analysis 9Insulin Pump Market & Forecast - Worldwide Analysis 10Insulin Pump Market & Forecast - Worldwide Analysis 11Insulin Pump Market & Forecast - Worldwide Analysis 12Insulin Pump Market & Forecast - Worldwide Analysis 13Insulin Pump Market & Forecast - Worldwide Analysis 14Insulin Pump Market & Forecast - Worldwide Analysis 15Insulin Pump Market & Forecast - Worldwide Analysis 16Insulin Pump Market & Forecast - Worldwide Analysis 17Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4
... NEW YORK, Aug. 31 Reportlinker.com announces that a ... The Market for Medical Devices in ... http://www.reportlinker.com/p0285742/The-Market-for-Medical-Devices-in-Brazil-Russia-India--China.html Many are concerned that the ... the BRIC countries. Is this a time of exciting ...
... YORK, Aug. 31 /PRNewswire/ Reportlinker.com announces that a ... catalogue: Hormone Replacement Therapy in ... 2017 http://www.reportlinker.com/p0254468/Hormone-Replacement-Therapy-in-Menopause---Pipeline-Assessment-and-Market-Forecasts-to-2017.html ... Assessment and Market Forecasts to 2017 ...
Cached Medicine Technology:Reportlinker Adds The Market for Medical Devices in Brazil, Russia, India & China 2Reportlinker Adds The Market for Medical Devices in Brazil, Russia, India & China 3Reportlinker Adds The Market for Medical Devices in Brazil, Russia, India & China 4Reportlinker Adds The Market for Medical Devices in Brazil, Russia, India & China 5Reportlinker Adds The Market for Medical Devices in Brazil, Russia, India & China 6Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 2Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 3Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 4Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 5Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 6Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 7Reportlinker Adds Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017 8
(Date:4/23/2014)... of Midlife Occupational and Leisure Time Physical Activity on ... activity in midlife increases the risk of mobility limitation ... risk. This is found in a study which followed ... study was conducted at the Gerontology Research Center in ... Heavy physical labor is often repetitive, wears the body ...
(Date:4/22/2014)... the United States with 1 million participants annually. A ... Injury Research and Policy at Nationwide Children,s Hospital is ... distribution patterns of basketball-related injuries treated in emergency departments ... and teens. , The study, published online in the ... to adolescents 13-19 years of age who were treated ...
(Date:4/22/2014)... 2014 Researchers at UT Southwestern Medical Center are ... depression . , A team of physician-scientists at ... ghrelin (a hormone with natural anti-depressant properties) works inside ... new treatment for depression in the form of a ... study, published online in April,s issue of Molecular ...
(Date:4/22/2014)... mice and rabbits, Johns Hopkins scientists have found a ... successfully preventing the development of atherosclerosis, the main cause ... of death among humans. The condition develops when fat ... stiff, narrowed and hardened, greatly reducing their ability to ... brain. , In a series of experiments, described April ...
(Date:4/22/2014)... LAKE CITY)A computational tool developed at the University of ... unknown gene mutations in three separate cases, U of ... study in The American Journal of Human Genetics ... tool), identifies undiagnosed illnesses and unknown gene mutations by ... that code for genes are made, in individual patients ...
Breaking Medicine News(10 mins):Health News:Midlife occupational and leisure-time physical activity limits mobility in old age 2Health News:New study finds 2.5 million basketball injuries to high school athletes in 6 seasons 2Health News:New study finds 2.5 million basketball injuries to high school athletes in 6 seasons 3Health News:Depressed? Researchers identify new anti-depressant mechanisms, therapeutic approaches 2Health News:Depressed? Researchers identify new anti-depressant mechanisms, therapeutic approaches 3Health News:Scientists alter fat metabolism in animals to prevent most common type of heart disease 2Health News:Scientists alter fat metabolism in animals to prevent most common type of heart disease 3Health News:Scientists alter fat metabolism in animals to prevent most common type of heart disease 4Health News:Applying math to biology: Software identifies disease-causing mutations in undiagnosed illnesses 2Health News:Applying math to biology: Software identifies disease-causing mutations in undiagnosed illnesses 3
... The Company,s Commitment to Healthy and Successful Vascular ... Lifeline Vascular Access(SM), the nation,s leading provider ... its network of managed vascular access centers has ... with the Lifeline Vascular Access managed center Nephrology ...
... their full range of 7Fr IAB catheters and immediate release in the ... ... Insightra Medical Inc. , a privately held medical device company based in ... sizes including: 40cc, 35cc, 30cc, 25cc and 20cc, all in a true ...
... bleeding inside the heart after people have suffered a heart ... published today in the journal Radiology . , The ... damaged a person,s heart is after a heart attack. The ... London, hope that this kind of imaging will be used ...
... Boston, MA A collection of hospitals in eight cities ... a simple surgical checklist during major operations can lower the ... The year-long study was led by researchers from the Harvard ... Health Organization, and the results are published Online First on ...
... during breast-feeding, but resistant disease can develop in first ... -- The antiretroviral drug nevirapine may help prevent babies ... but it also greatly increases the odds of developing ... year of life, a new study finds. , Still, ...
... company, Oral BioTech, is embracing this new research on xylitol with ... Part of the motivation for these products has been the relative ... products. , ... Albany, OR (PRWEB) January 18, 2009 ...
Cached Medicine News:Health News:Lifeline Vascular Access Treats a Quarter Million Patients 2Health News:Lifeline Vascular Access Treats a Quarter Million Patients 3Health News:Insightra Medical, Inc. Gains FDA clearance for the Most Complete Range of 7Fr Intra Aortic Balloon (IAB) Catheters 2Health News:Insightra Medical, Inc. Gains FDA clearance for the Most Complete Range of 7Fr Intra Aortic Balloon (IAB) Catheters 3Health News:Bleeding hearts revealed with new scan 2Health News:Hospitals demonstrate surgical safety checklist drops deaths and complications by more than a third 2Health News:Hospitals demonstrate surgical safety checklist drops deaths and complications by more than a third 3Health News:Hospitals demonstrate surgical safety checklist drops deaths and complications by more than a third 4Health News:HIV Drug a Double-Edged Sword for Infants 2Health News:Keeping Kids Cavity-Free Before They're Ever Born: CariFree Believes Xylitol Could be This Generation's Answer 2Health News:Keeping Kids Cavity-Free Before They're Ever Born: CariFree Believes Xylitol Could be This Generation's Answer 3
Straight shafts with 1 x 2 teeth and 5 mm tying platform. Serrated handle with dull finish....
Straight shafts with 1 x 2 teeth and 6 mm tying platform. Wide serrated handle with polished finish....
Serrated, 10 mm tips angled 30 degrees. Serrated cross action handle with polished finish....
Straight shafts with 1 x 2 teeth and 6 mm tying platform. Wide smooth handle with polished finish....
Medicine Products: