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:12/19/2014)...  Monarch America Inc. (OTCQB: CANK) ("Monarch America" or ... provide this review of the Company,s recent achievements and ... "Over this past year, we achieved many of our ... to say that Monarch America is in a stronger ... been," stated Eric Hagen , CEO of Monarch ...
(Date:12/19/2014)... Research and Markets ( http://www.researchandmarkets.com/research/942kh3/micro_market ... "Micro Market Monitor: North American Dermatology Diagnostic Devices ... http://photos.prnewswire.com/prnh/20130307/600769 Cosmetic ... has resulted in fueling the overall demand of ... of these dermatology devices is to assist in ...
(Date:12/19/2014)... DIEGO , Dec. 18, 2014  RESMED INC. (NYSE: ... its second quarter of fiscal year 2015 results on Thursday, ... close. A press release with ResMed,s results will be issued ... host a webcast to discuss operating results and future outlook. ... 1:30 p.m. US Pacific Time and the live webcast of ...
Breaking Medicine Technology:Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 3Micro Market Monitor: North American Dermatology Diagnostic Devices Market 2Micro Market Monitor: North American Dermatology Diagnostic Devices Market 3ResMed To Announce Second Quarter 2015 Results 2
... Inc. (Nasdaq: IDIX ), a biopharmaceutical company engaged ... of human viral diseases, today announced that two abstracts have ... the European Association for the Study of the Liver (EASL, ... can now be viewed at the EASL website at www.easl.eu. ...
... (Nasdaq: IDIX ) announced today that management will ... Stock Conference on Monday, March 14, 2011 at 12:00 p.m. ... California and at the Barclays Capital 2011 Global Healthcare Conference ... the Loews Miami Hotel, Florida. The live and ...
Cached Medicine Technology:Idenix Announces Data Presentations at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) 2Idenix Announces Data Presentations at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) 3
(Date:12/21/2014)... Hills, Ca (PRWEB) December 21, 2014 ... Khanna was a guest at the Aspen Helicopters holiday ... kids and a Santa with sleigh, flown by an ... helicopter appeared invisible; only Santa with sleigh was visible.(please ... during day and night. Dr.Khanna has helped many pilots ...
(Date:12/21/2014)... Recently, one of the best prom dresses online shops ... introduced its new collection of 2015 prom dresses, and ... its prom dresses & other fashionable designs, up to ... quality dress products and great customer services to its ... the best prom dresses online shops around the world ...
(Date:12/21/2014)... (PRWEB) December 21, 2014 Over the ... performance issues in hundreds of emergency departments across the ... Its findings have been translated into an innovative suite ... to correct deficiencies and enhance the patient experience. ... emergency physician staffing and management services for hospitals, announced ...
(Date:12/21/2014)... The Oncology Institute of Hope and Innovation hosted ... Whittier offices. The Hope for the Holidays Toy Drive is ... their families during the holiday season. This year, the toy ... between both offices. This event continues to be successful year ... team, store managers and assistant managers came out and not ...
(Date:12/20/2014)... has recently announced its new collection of sweet 16 ... dresses for the coming new year. , Weddingshe.com ... global women. Now, all the models on its website ... Among the new items, the model of 10986064 (Fresh ... popular. What’s more, Weddingshe.com also provides a fast and ...
Breaking Medicine News(10 mins):Health News:New Prom Dresses From One Of The Best Prom Dresses Online Shops, LunaDress Prom Shop 2Health News:NES Health Launches Stipend Program for Emergency Physicians in Training to Financially Assist Emergency Department Doctors While They Learn 2Health News:Tons of New-in Winter Sweet 16 Dresses from Weddingshe Online Now 2
... survey conducted by Synovate India and sponsored by Colgate-Palmolive (India) ... and the latest toothpaste available in the market, //the level ... of those surveyed admitted that they have never been to ... that poor oral hygiene practices are resulting in a myriad ...
... more than 5.13 million patients are suffering from AIDS ... being reported each year. Anti-retroviral treatments //have already been ... ,The priority of the Indian Government is to save ... Inorder to increase awareness and promote community participation, of ...
... his research team from Kyoto University have found that daily ... The results of the study have been published in the ... conducted in 387 healthy volunteers between the age group of ... into three groups, the first group gargled water with povidone-iodine, ...
... growing number of animal and human studies show that ... pain sensitivity, resulting in hyperalgesia (abnormally intense pain in ... in response to non-painful stimulation). , ... previous studies have found evidence for hyperalgesia only subsequent ...
... findings released by University of Florida doctors claim that some ... radiation therapy if they undergo a CT scan.// This scan ... the researchers claim. ,These findings were presented at ... and Oncology. Stanley L. Liauw, M.D., a resident in radiation ...
... was first initiated in India to help overcome Vitamin ... in India, it now lags behind African and neighbouring ... report.,The report entitled "Controlling Vitamin and Mineral Deficiencies in ... the largest percentage as well as the largest absolute ...
Cached Medicine News:Health News:Condom Vending Machines To Be Installed Across Indian States 2Health News:Daily Gargling May Prevent Common Colds 2Health News:Opioids And Abnormal Pain Perception 2Health News:Vitamin A supplementation inadequate in India: Need for effective strategies 2
Modular Specimen Filing System has five cells that can hold either slides or tissue cassettes....
... an expanded database containing over 330 ... cards, VITEK 2 Compact offers enhanced ... of time (2 to 14 hours), ... microorganisms that contaminate production areas and ...
... is a comprehensive hemodynamic monitoring and ... lab. Patient demographics, clinical hemodynamic ... procedural information all flow seamlessly into ... repetitive data entry. Both ...
... generation product is a patient monitoring system ... parameters, sensed at the tissue level, reflecting ... tissue by low power light and detects ... tissue. The light is guided to the ...
Medicine Products: