Navigation Links
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
Date:2/5/2010

Agency says Bayesian statistical methods could trim costs, boost efficiency

SILVER SPRING, Md., Feb. 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The combined data may provide sufficient justification for smaller or shorter clinical studies.

"This final guidance on the use of Bayesian statistics is consistent with the FDA's commitment to streamline clinical trials, when possible, in order to get safe and effective products to market faster," said FDA Commissioner Margaret A. Hamburg, M.D. "This is a terrific example of regulatory science in practice at FDA."

The FDA has substantial experience in the use of Bayesian statistical methods for the design and analysis of scientifically valid clinical studies. The FDA has approved a number of medical devices whose approval applications submitted to the FDA included clinical studies that used these statistical methods.

The final guidance, titled "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials," describes use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and diff
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Older female cancer survivors have added health issues compared to their counterparts
2. NVHR Issues Challenge to Administration, Congress: Dont Leave 5 Million Americans Afflicted with Chronic Viral Hepatitis Out in the Cold with Budget Freeze
3. Operation Rescues Advisory Board Issues Statement on Mr. Terrys Extremism
4. Greenfaith Ministry Calls on Churches & Doctors, to Address all Cannabis Issues and Regulation
5. School Support Lacking for Emotional, Behavioral Issues, say Parents
6. APS Healthcare Issues First Award to South Carolina Providers Using Data to Increase Effectiveness of Mental Health Treatment
7. Largest RN Union Issues Urgent Call for Nurse Volunteers to Assist Earthquake Ravaged Haiti
8. National Council on Disability to Hold Houston Meeting to Hear Issues Affecting People With Disabilities
9. Phyhealth Issues September 30, 2009 Financial Statements
10. Squeezing Costs out of Healthcare Tops PricewaterhouseCoopers List of Health Industry Issues in 2010
11. Half of U.S. Kids With Mental Issues Are Getting Help
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... together with the Chinese Thoracic Society (CTS) announced ... CHEST World Congress 2016 will be held in ... sleep medicine from around the world are expected ... 2016. , CHEST World Congress 2016 will ... keynote addresses, presentations by leading health-care experts, and ...
(Date:9/18/2014)... Qualis Health, one of the nation’s leading population ... “Advancing Primary Care through the Patient-Centered Medical Home Model ... Jeff Hummel, MD, MPH and Peggy C. Evans, PhD, ... the work of becoming a Patient-Centered Medical Home (PCMH) ... such as generating and providing useful data that can ...
(Date:9/18/2014)... A group of international scientists have developed a new ... here . , The Wildlife Conservation Society (WCS)-led ... Tropical Diseases , describes the use of fecal samples ... have been exposed to the virus. This represents a ... can potentially change the way Ebola virus is studied ...
(Date:9/18/2014)... guidelines recommending that elderly men should not be routinely ... according to a new study led by researchers at ... letter online in JAMA Internal Medicine , focused ... to test for prostate cancer., "We found that the ... of elderly men in particular has been minimal at ...
(Date:9/18/2014)... New York (PRWEB) September 18, 2014 ... the easy availability of products such as smart phones, ... been observed in the way mobile devices are viewed ... or record personal data to becoming a mode for ... technology has come a long way. , ...
Breaking Medicine News(10 mins):Health News:CHEST announces China as site of CHEST World Congress 2016 2Health News:Advancing Primary Care Through PCMH and HIT: New White Paper Connects the Dots 2Health News:Research yields a game changer for improving understanding of Ebola and great apes 2Health News:Research yields a game changer for improving understanding of Ebola and great apes 3Health News:Professional recommendations against routine prostate cancer screening have little effect 2Health News:Transparency Market Research: M-health Market Study 2018 2Health News:Transparency Market Research: M-health Market Study 2018 3Health News:Transparency Market Research: M-health Market Study 2018 4
... 7 /Xinhua-PRNewswire-FirstCall/ -- China,Pharma Holdings, Inc. ("China Pharma") ... generic and branded speciality,pharmaceutical products in China, today ... 2008., Financial Highlights -- 3Q08 ... -- $35.6 Million Revenue for nine months ended ...
... Nearly 700 health plans evaluated based on quality ... U.S. News Media Group and The,National Committee ... edition of America,s Best Health Plans on USNews.com. ... of Americans prepare to,select their healthcare coverage, the ...
... in several podium,presentations at American Society for ... Nov. 7 Reliant Technologies, Inc., the,pioneer ... aesthetic laser skin,treatments, today announced that study ... laser technology will be presented at the,American ...
... ingredients, green chemistry technology in self-adjusting ... ... Global nutrition leader XanGo,LLC, today announced the official launch of ... City. This personal care,brand features exclusive ingredients from the mangosteen delivered ...
... Nov. 7 NutraCea (OTC Bulletin Board:,NTRZ), a world ... today announced financial results for its third quarter ended,September ... quarter increased to $11.2 million,compared with net revenues of ... driven by a $1.9 million increase in net revenues ...
... medical home, personal health records and emergency,department coverage will ... conference presented by the Michigan State Medical Society (MSMS),on ... at The Inn at St. John,s,in Plymouth., State ... of the emerging health care model that ensures coordinated,patient ...
Cached Medicine News:Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 2Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 3Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 4Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 5Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 6Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 7Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 8Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 9Health News:China Pharma Holdings, Inc. Reports Third Quarter 2008 Financial Results and Corporate Updates 10Health News:U.S. News Media Group and NCQA Release 2008 Rankings for America's Best Health Plans 2Health News:U.S. News Media Group and NCQA Release 2008 Rankings for America's Best Health Plans 3Health News:Fraxel(R) Laser Systems Shown to Provide Superior Results Compared to 'Pseudo Fractional' Laser Technologies 2Health News:Fraxel(R) Laser Systems Shown to Provide Superior Results Compared to 'Pseudo Fractional' Laser Technologies 3Health News:Fraxel(R) Laser Systems Shown to Provide Superior Results Compared to 'Pseudo Fractional' Laser Technologies 4Health News:XanGo Introduces Glimpse(TM) Intuitive Skin Care 2Health News:XanGo Introduces Glimpse(TM) Intuitive Skin Care 3Health News:NutraCea Announces Third Quarter 2008 Financial Results 2Health News:NutraCea Announces Third Quarter 2008 Financial Results 3Health News:NutraCea Announces Third Quarter 2008 Financial Results 4Health News:NutraCea Announces Third Quarter 2008 Financial Results 5Health News:NutraCea Announces Third Quarter 2008 Financial Results 6Health News:NutraCea Announces Third Quarter 2008 Financial Results 7Health News:NutraCea Announces Third Quarter 2008 Financial Results 8Health News:NutraCea Announces Third Quarter 2008 Financial Results 9
(Date:9/18/2014)... Sept. 18, 2014 This BCC Research report discusses the ... players, market growth and size, and opportunities for different devices ... through 2018. Patent analysis in the report focuses on technological ... Europe and Japan ... and discuss the global medical device technologies market. - Analyze ...
(Date:9/18/2014)... and LONDON , Sept. ... for biopharmaceutical companies. Competition for innovation, increasing clinical ... keep up with the fast-changing environment are important ... clinical trials, and clinical trial costs continue to ... recruitment. Studies conducted by industry think ...
(Date:9/18/2014)... MEETING, Pa. , Sept. 18, 2014  Iliad ... innovative approaches to diagnosing and treating Autism Spectrum Disorders ... Exclusive License Agreement with The Research Foundation for The ... Agreement, Iliad will provide a new biomarker to identify ... with susceptibility to ASD. This biomarker is expected to ...
Breaking Medicine Technology:Medical Devices: Technologies and Global Markets 2Medical Devices: Technologies and Global Markets 3Medical Devices: Technologies and Global Markets 4Patient Recruitment in Asia Biotech and Pharma Companies 2Patient Recruitment in Asia Biotech and Pharma Companies 3Iliad Neurosciences, Inc. enters into an Exclusive License Agreement with The Research Foundation for The State University of New York 2Iliad Neurosciences, Inc. enters into an Exclusive License Agreement with The Research Foundation for The State University of New York 3
... ANGELES, Oct. 18 One of the most difficult-to-remove tumors ... excised thanks to the work of one Los Angeles surgeon. ... Base Institute in Los Angeles, has developed a minimally invasive ... shape. The new procedure is expected to replace the more ...
... ongoing or chronic pain, opioids (medications such as oxycodone or ... to function at near-normal levels.  For those with acute pain, ... with opioids can speed healing and recovery. ... are not used properly. According to the Centers for Disease ...
Cached Medicine Technology:Dr. Hrayr Shahinian of the Skull Base Institute Develops Revolutionary Endoscopic Procedure 2Opioid Education Lags as Abuse Climbs 2Opioid Education Lags as Abuse Climbs 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... 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 extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
Medicine Products: