Navigation Links
Statistical Challenges in Medical Device Trail Evaluation
Date:5/17/2013

SHANGHAI, May 17, 2013 /PRNewswire/ -- Medical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device (MD) trail evaluations are much more complicated than drug trails due to their unique clinical practices. Currently, the EMEA only evaluates MD safety instead of evaluating both safety and efficacy (which is left to the market), while the US FDA (which is the same as the SFDA) evaluate MDs for both safety and efficacy (510K). In this case, is the process for evaluating MD safety and efficacy using the same statistical principles as drugs?

Based on the unique features of medical devices, in such trials, the statistical inferences may carry a lower level of scientific assurance. How to smooth the impact of the potential biases? Big challenges exist to minimize bias from several sources, including:

  • Operator selection bias
  • Patient selection bias (demography of patients)
  • Unblinding trial, evaluation bias
  • OPC determination
  • Agreement evaluation for diagnostic trial

There is an urgent need to develop specific guidelines for each kind of medical device in order to evaluate their efficacy and safety properly. MRBC has been involved into the guideline writings for SFDA (Type III) trials.

Li Wei , Director for National Center for Cardiovascular Diseases China and Visiting Professor at The Chinese University of Hong Kong, Expert Review for Clinical Trials, SFDA, will share his insights into the use of safety and efficacy evaluation methods for medical devices from the statistics perspective, which will help type III medical device manufacturers to gain the latest device trial evaluation guidance during the 3rd Annual Implantable and Interventional Medical Devices China Conference 2013, o
'/>"/>

SOURCE UBM Conferences
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Treatment With VP20621 (Non-Toxigenic Clostridium difficile; NTCD) In A Phase 2 Study Resulted In High Rates Of Colonization And Statistically Significant Reductions In Recurrence Of C. difficile Infection
2. Rockwell Medical Announces Iron Delivery Drug SFP Meets Primary Endpoint in PRIME Clinical Study Demonstrating Statistically Significant 37% Reduction in ESA Dose
3. Natural Tree Extract (Larch Arabinogalactan) Shown to Have Statistically Significant Effect in Protecting Immune Health
4. Silicon Nitride Demonstrates Statistical Superior Osteointegration and Anti-infective Biomaterial Properties
5. ELNs, Data Analytics, Knowledge Management: Trends, Challenges & Opportunities
6. Frost & Sullivan: Growing Reimbursement Challenges Force Hospitals to Reengineer Revenue Cycle Management
7. Americas Biopharmaceutical Companies Commitment to Research Remains Strong Despite Challenges
8. Forum Tackles the Rising Costs, Challenges and Diminished Outcomes Associated with Treating Obese Patients for Orthopaedic Conditions
9. Global Blood Glucose Test Strips Market 2011-2015 Report Discusses That One of the Main Challenges in This Market Is the Availability of Advanced Non-Invasive Blood Glucose Monitoring Devices
10. Quiz that Challenges People to Learn if Their Bodies are Toxic is Posted on TimetoCleanse.com
11. ERISA Creates Benchmarking Challenges for Plan Sponsors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 2014 The consumer marketing playbook and ... sectors to better identify winning tools and techniques. ... with and understand consumers, as new technologies are ... purchasing decisions. According to recent ... area where organizations can observe a deep pool ...
(Date:7/11/2014)... 2014  Kindred Hospital Houston Northwest, with Wound ... of its new outpatient wound healing center.  The ... with chronic, hard to heal wounds. Chronic wounds ... amputation, lower leg wounds related to blood flow ... traumatic injury wounds which are complex and demonstrate ...
(Date:7/11/2014)... July 11, 2014  Veran Medical Technologies, ... today the positive, cost-effective final results for ... procedure. The SPiNPerc endobronchial percutaneous biopsy study ... approach to biopsy when a traditional bronchoscopic ... physicians experience positive financial outcomes when more ...
Breaking Medicine Technology:New Technologies Transforming Consumer Marketing Research Playbook 2Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Veran Medical Publishes Lung Cancer Patient Management Study 2
... Scientific Presentations Detail Progress with VeraTag(TM) Assays in Breast ... ... (Nasdaq: MGRM ) today announced five posters to be,presented at the 30th ... - 16, 2007. Following are details for,each embargoed session:, -- Friday, ...
... Tainted Research Grant Applications Must Be Rejected, Consumer,Advocates ... More apparent,conflict of interest violations in applications for ... were revealed today and the,Foundation for Taxpayer and ... to be rejected., The latest improprieties were ...
Cached Medicine Technology:Monogram Announces Posters to be Presented at the 30th San Antonio Breast Cancer Symposium 2Monogram Announces Posters to be Presented at the 30th San Antonio Breast Cancer Symposium 3New Conflict of Interest Violations Revealed at California Stem Cell Institute 2New Conflict of Interest Violations Revealed at California Stem Cell Institute 3
(Date:7/13/2014)... Advanced boilers are preferred over conventional ... fossil fuels, produce high-capacity power, emit fewer pollutants, ... warming and climate change concerns, many countries have ... emissions and pollutants coming from fossilfuel-based power plants.North ... advance boilers market., The global power rental market ...
(Date:7/13/2014)... 2014 MarketsandMarkets recently conducted a ... 3D Scanning; 3D rendering; Layout and Animation; Image ... - 2018)”, which analyzes and studies the major ... Western Europe, Eastern Europe, Middle East and Africa, ... the competitive landscape of the 3D imaging market, ...
(Date:7/13/2014)... 13, 2014 The Pearland, Texas location of ... age from four months to 12 years of age that ... to birthday parties and Summer Camps, is now under new ... of Pearland after spending over six years at The ... Gym Director. , Berry has over ten years of ...
(Date:7/13/2014)... Recently, 2014QuinceaneraDresses.com, the distinguished special occasion dress manufacturer ... gorgeous Quinceanera dresses . , In ... outfits is huge. Therefore, 2014QuinceaneraDresses.com is striving to ... released dresses are made according to the latest ... , It is worthy of mention that ...
(Date:7/13/2014)... Fadhits.com is popular among worldwide women. Its lace ... Recently, the company has announced its new selection of ... all these outfits are available at discounted prices (from ... supplier is now offering similar discounts for many other ... many other designs for sale, including flower girl dresses, ...
Breaking Medicine News(10 mins):Health News:North America Advanced Boilers Market is Expected to Reach $518.7billion by 2019 - New Report by MicroMarket Monitor 2Health News:North America Advanced Boilers Market is Expected to Reach $518.7billion by 2019 - New Report by MicroMarket Monitor 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 2Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 4Health News:The Little Gym of Pearland, TX Now Under New Ownership and Management 2Health News:2014QuinceaneraDresses.com Releases Its New Quinceanera Dresses 2Health News:Fadhits.com Announces a Special Offer on Elegant Quinceanera Dresses 2
... the weight students and hikers carry. ,The bungee ... University of Pennsylvania// , could be useful for students, hikers, ... ,It uses two short bungee cords instead of inflexible straps ... load at a constant level from the ground. ...
... Scientists at the National Institute of Arthritis and Musculoskeletal ... of Health in Bethesda, Md., and colleagues at the ... in unprecedented detail, the virus that causes influenza. ... Steven, Ph.D., working with a version of the seasonal ...
... much appreciated, the US Consumer Product Safety Commission announced the ... name BABYBJ'RN? Feeding Spoons. , The company BabySwede LLC ... taken in response to consumer feedback regarding the safety of ... tips of the spoon were observed to soften and break ...
... of Rs.110,000 on a private hospital and its doctor-owner in ... district consumer redressal forum Saturday fined the Balasore-based City Clinic ... uterus of Shila Jana on July 23, 2002, the patient's ... resident of Gobara village under the Ramnagar police station in ...
... There may be another reason for pregnant and nursing women ... cruciferous vegetables like broccoli and cabbage// – it could help ... in life. ,A new study by scientists ... with laboratory mice, found that supplements of a key phytochemical ...
... Association (BMA) plans collaboration with the Indian Medical Association (IMA) ... medical graduates to train in Britain. ,BMA president Praveen ... national conference of the IMA, said: "I had a fruitful ... was eager for a close and active collaboration with the ...
Cached Medicine News:Health News:Molecular Anatomy of Influenza Virus Detailed 2Health News:Mother’s Diet During Pregnancy Could Prevent Cancer in Childre 2Health News:Mother’s Diet During Pregnancy Could Prevent Cancer in Childre 3
Pipetman P is a fully adjustable, air-displacement pipette with the selected volume shown on a digital indicator (volumeter). Eight models cover the full range of volumes from 0.2 L to 10 mL....
... Finnpipette Digital offers improved ergonomics for ... handle, modified grippy finger rest and ... comfort and efficiency. Finnpipette Digitals also ... gearing mechanism (pat. pend.) and super ...
Research Series 2100 Adjustable-volume Pipette,100-1,000 l, single-channel with adjustable-volume setting...
... The Sysmex pocH-100i is the first ... with low daily testing requirements. With its ... 3-part differential from just 15 L of ... for any small healthcare site including the ...
Medicine Products: