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

0

GOOD

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:5/23/2013)... -- Net Medical Xpress Solutions, Inc., (OTC QB: NMXS), a ... has signed a letter of intent to acquire MedTel ... Huntsville, AL . MedTel Solutions is a physician ... of telemedicine physicians. Consideration for the acquisition will be ... expected by June 30, 2013. Dick Govatski, ...
(Date:5/23/2013)...  BioElectronics Corporation (OTC Pink: BIEL), the maker of ... FDA panel meeting for non-thermal shortwave diathermy: ... Therapy Meeting was held on May 21, 2013 in ... of the meeting was very narrow, in that the ... the application of non-thermal shortwave diathermy for the treatment ...
(Date:5/23/2013)... May 23, 2013 Israel Brain Technologies ... , Israel,s 1 st International ... th -15 th in Tel Aviv ... city in the world by the Wall Street Journal ... BrainTech Israel 2013 will showcase the latest breakthroughs in neuroscience ...
Breaking Medicine Technology:Net Medical Xpress Announces Acquisition of Telemedicine Staffing Company 2Net Medical Xpress Announces Acquisition of Telemedicine Staffing Company 3BioElectronics and Pulsed Shortwave Therapy Make Progress 2Israel Brain Technologies Announces Israel's 1st International Brain Technology Conference 2Israel Brain Technologies Announces Israel's 1st International Brain Technology Conference 3
... , Elsevier,s Pageburst platform to be ... Program Elsevier, the leading global provider of ... today that West Kentucky Community and Technical College ... Technical College System and a public, two-year, degree-granting institution ...
... patent covering tumor suppression technologies, including the company,s lead ... The University of Texas System by the ... discovery that chromosome 3p21.3 genes act as cancer suppressors. ... as FUS1, the anti-cancer agent in Oncoprex ...
Cached Medicine Technology:West Kentucky Community and Technical College Embraces Elsevier's Digital Textbook Platform for Radiography Program 2West Kentucky Community and Technical College Embraces Elsevier's Digital Textbook Platform for Radiography Program 3Genprex Announces New Patent Issuance in Japan 2
(Date:5/23/2013)... (PRWEB) May 23, 2013 According to ... [Converged Services; Policy Management; Subscriber Data Management (SDM); Telecom ... Forecasts and Analysis (2013 – 2018)", published by MarketsandMarkets, ... by 2018 at a CAGR of 9.15% from 2013 ... Market Data Tables , 84 Figures , ...
(Date:5/23/2013)... May 23, 2013 DRE, Inc. is ... as a solution to upgrade older model DRE ... the entire lighting system. , DRE and BFW ... DRE or BFW halogen headlights to LED with DRE’s ... C3 LED Conversion Kit provides a bright, clean and ...
(Date:5/23/2013)... Linda, CA (PRWEB) May 23, 2013 Located ... Fit Body Boot Camp Yorba Linda held its Grand Opening ... goal of spreading awareness about multiple sclerosis and physical fitness. ... premier health and wellness company, the fun filled Grand Opening ... camp prize to show the community what the Yorba ...
(Date:5/23/2013)... Los Angeles,Ca (PRWEB) May 23, 2013 ... with removing every sign associated with Rosacea. This condition ... skin and can affect a person’s self-image. Manufacturers have ... work to help constrict blood vessels near the surface ... and flushing. The new formula is available with special ...
(Date:5/23/2013)... (PRWEB) May 23, 2013 In Florida, residents ... years. This doesn’t mean, however, that Florida’s good luck will ... Center . This year, he encourages residents, it is important ... season 2013, forecasters are predicting there to be a 50-percent ... WUFT . With hurricane season lasting from June 1 to ...
Breaking Medicine News(10 mins):Health News:Service Delivery Platform (SDP) Market Is Growing at a CAGR of 9.15% & to Reach $6.94 Billion by 2018 - New Report by MarketsandMarkets 2Health News:Service Delivery Platform (SDP) Market Is Growing at a CAGR of 9.15% & to Reach $6.94 Billion by 2018 - New Report by MarketsandMarkets 3Health News:New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems 2Health News:New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems 3Health News:Yorba Linda Personal Trainer Celebrates Fit Body Boot Camp Yorba Linda Grand Opening by Hosting a Family Fun Charity Event 2Health News:Yorba Linda Personal Trainer Celebrates Fit Body Boot Camp Yorba Linda Grand Opening by Hosting a Family Fun Charity Event 3Health News:Revitol Rosacea Now Comes with Anti-Inflammatory Ingredients to Remove Redness and Flushing 2Health News:As Hurricane Season Nears, Skylake Insurance Encourages Florida Residents To Prepare Early For Safety 2
... Common Shares Issued and Listed on OTCBB, ... (OTC Bullets and Board: CHHB) (,China,Bio-Immunity" or "the ... share exchange agreement with Lawford Asia Limited (,Lawford,).,According ... all of the issued and outstanding stock of ...
... Grant Stevens, MERRIMACK, N.H., Aug. 6 ... Medical Inc. announced today that Grant,Stevens, MD, will ... to offer,the SmoothShapes(R) system for longer lasting cellulite ... dynamic light therapy, in addition,to contoured rollers and ...
... eDiets.com,Inc. (Nasdaq: DIET ), leveraging the power of ... to everyone, today announced,results for the second quarter and ... the second quarter of 2008 were $6.5 million, compared ... for the quarter was $(3.1),million, or $(0.12) per diluted ...
... Raritan, NJ, August 6, 2008 The nation,s first, ... (cSSTIs), known as SSTIR (the Skin and Soft Tissue ... plans to enroll more than 1,200 hospitalized patients by ... better understand treatment patterns and provide data to help ...
... study finds , , WEDNESDAY, Aug. 6 (HealthDay News) -- Stroke ... times as likely to die in the hospital or be ... new Canadian study suggests. , The finding is based ... recovery from an ischemic stroke. Ischemic strokes are the most ...
... than to adults. That,s one reason why abstinence-only ... sexual activity, according to new University of Washington research., , ... treated abstinence and sexual activity as opposites. However, teenagers ... Tatiana Masters, lead author of a new study and ...
Cached Medicine News:Health News:China Bio-Immunity Corporation Completes Share Exchange and Reverse Merger 2Health News:China Bio-Immunity Corporation Completes Share Exchange and Reverse Merger 3Health News:China Bio-Immunity Corporation Completes Share Exchange and Reverse Merger 4Health News:New Anti-Cellulite Treatment Prepares Women for Fall's Short Skirts 2Health News:New Anti-Cellulite Treatment Prepares Women for Fall's Short Skirts 3Health News:eDiets.com(R) Announces Q2 2008 Results 2Health News:eDiets.com(R) Announces Q2 2008 Results 3Health News:eDiets.com(R) Announces Q2 2008 Results 4Health News:eDiets.com(R) Announces Q2 2008 Results 5Health News:eDiets.com(R) Announces Q2 2008 Results 6Health News:eDiets.com(R) Announces Q2 2008 Results 7Health News:Ortho-McNeil initiates first-of-its-kind skin infection registry 2Health News:GI Bleeding After Stroke Raises Death Risk 2Health News:GI Bleeding After Stroke Raises Death Risk 3Health News:When it comes to abstinence teens, adults aren't speaking the same language 2Health News:When it comes to abstinence teens, adults aren't speaking the same language 3
Bartels Clostridium difficile Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficile Toxin A in human faecal specimens as an aid in the diagnosis of Clost...
One step Immuno-Chromatographic Assay for the detection of C. difficile toxin A....
... CCD cameras provide fast, accurate, reliable and ... quality at an excellent price. , , ... TOMEY TR-4000 Auto Refractor provides highly accurate ... is obtained simply by pushing a button. ...
... Rechargeable, cordless slit-lamp microscope Portable, for ... Easy selection of slit width , ... halogen lamp light source , Simultaneous ... pack , Supports digital / video ...
Medicine Products: