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:9/2/2015)... MONROVIA, Calif. , Sept. 2, 2015 STAAR ... and marketer of implantable lenses and delivery systems for the ... William P. Wall to the Company,s Board. ... Abrams Capital, a Boston -based investment firm, ... member of the Board of Directors, and chair of the ...
(Date:9/2/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/l8z67c/pharmaceutical ) has ... China (Basel, Switzerland - November 26-27, 2015)" conference to ... detailed overview of the key areas of pharmaceutical regulatory affairs ... , Macau and ... All important aspects of gaining and maintaining a successful Marketing ...
(Date:9/2/2015)... , Sept. 2, 2015 Amgen ... of a Marketing Authorization Application (MAA) to the ... for etelcalcetide (formerly AMG 416) for the treatment ... chronic kidney disease (CKD) on hemodialysis therapy. If ... that can be administered intravenously. Etelcalcetide ...
Breaking Medicine Technology:William P. Wall Appointed to STAAR Surgical Board of Directors 2Pharmaceutical Regulatory Affairs in China Seminar: Basel, Switzerland - November 26-27, 2015 2Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 2Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 3Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 4Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 5Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 6Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 7
...   Sunpeaks Ventures, Inc. (OTCBB: SNPK) (PINKSHEETS: ... wholly owned subsidiary Healthcare Distribution Specialists, LLC ("HDS") ... a marketing and distribution agreement with Asian American ... to distribute and sell Clotamin in 1,200 AACSA ...
... Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel ... has completed its previously announced sale of an aggregate ... warrants to purchase an additional 2,512,500 shares of common ... share.  The total gross proceeds from the registered direct ...
Cached Medicine Technology:Sunpeaks Ventures Announces Agreement with Asian American Convenience Store Association Partners to Sell Clotamin in 1,200 Stores 2Sunpeaks Ventures Announces Agreement with Asian American Convenience Store Association Partners to Sell Clotamin in 1,200 Stores 3Nile Therapeutics, Inc. Completes $1.34 Million Registered Direct Offering 2Nile Therapeutics, Inc. Completes $1.34 Million Registered Direct Offering 3
(Date:9/3/2015)... NC (PRWEB) , ... September 03, 2015 , ... ... August 31, 2015: DiabetesSisters is pleased to announce the additional of Carol Wysham, ... 2015 by current board members Diana Karczmarczyk, Donna Rice, David Warren, Matt Stella, ...
(Date:9/3/2015)... ... September 03, 2015 , ... ... endpoint data collection, cloud analytics and workflow solutions today announced the complete ... Portugal, September 22-24, 2015. The esteemed faculty of worldwide pharmaceutical and industry ...
(Date:9/3/2015)... ... September 03, 2015 , ... ... responsibilities which can impact the delicate life balance between work and leisure to ... - Jeffrey R. Leaptrott, CEO , A LifeMinder Plus® Emergency Care Document Set ...
(Date:9/3/2015)... ... September 03, 2015 , ... AvePoint, the established leader in ... Pack (SP) 4 – AvePoint’s solution for facilitating two-way collaboration and external sharing ... Trend-Setting Product”. This is the fifth consecutive year an AvePoint product has made ...
(Date:9/3/2015)... ... September 03, 2015 , ... Mum n Me is pleased to announce the ... extra-large size that gives maximum protection from sun exposure, wind, bugs, and germs. The ... deliver non-slip assurance by keeping the cover securely in place. The new car seat ...
Breaking Medicine News(10 mins):Health News:Carol H. Wysham, MD, Joins DiabetesSisters Board of Directors 2Health News:ERT Announces Final Agenda, Faculty for European PRO / eCOA Congress 2Health News:ERT Announces Final Agenda, Faculty for European PRO / eCOA Congress 3Health News:LifeMinder Plus® Announces Emergency Care Document Set Giveaway for America 2Health News:LifeMinder Plus® Announces Emergency Care Document Set Giveaway for America 3Health News:AvePoint Perimeter Named a “KMWorld 2015 Trend-Setting Product” 2Health News:AvePoint Perimeter Named a “KMWorld 2015 Trend-Setting Product” 3Health News:AvePoint Perimeter Named a “KMWorld 2015 Trend-Setting Product” 4Health News:Mum n Me Announces New Baby Car Seat Cover 2
... a colourless, odourless and tasteless chemical element - could ... ,Patients with chronic obstructive pulmonary disease (COPD) have ... the lungs at the end of each breath. This ... reasons for shortness of breath experienced by these patients, ...
... Here’s the good news, the bad news, and some more ... Americans, according to one recent study) are satisfied// with their ... way of having a good sex life, from prescription medication ... ,In many cases, physicians can work with their patients to ...
... Andhra Pradesh and Tamil Nadu will upgrade their existing ... ,"It has been decided to upgrade the hospitals in ... Vice Admiral surgeon Vijay K. Singh, director general of ... ,Singh said a Rs.3-billion budget has been sanctioned, ...
... one in three children in California is overweight or at ... health insurance company.// ,There are even more ... satellite cities. ,The number of overweight children ... rest of California, and nearly doubles the national rate, said ...
... Jammu and Kashmir by humanitarian group Médecins Sans Frontières (MSF) ... and more than one in 10 had been victims of ... ,The report by the Holland-based MSF is based on ... in mid-2005. The survey group defined 1989 as the beginning ...
... have made a Startling discovery. The researchers who want ... their intake of calories is restricted have found that ... on longevity in the fruit flies. ,Scientists ... increase the lifespan of many species, but the mechanism ...
Cached Medicine News:Health News:Helium Helps COPD Sufferers to Exercise 2Health News:Health Issues That Can Impact Sexual Satisfaction 2Health News:Health Issues That Can Impact Sexual Satisfaction 3Health News:Health Issues That Can Impact Sexual Satisfaction 4Health News:South India to Have Modern Military Hospitals 2Health News:Mental Health of Kashmiris Needs Urgent Attention: Survey 2Health News:Food Odors Linked With Lifespan in Fruit Flies 2Health News:Food Odors Linked With Lifespan in Fruit Flies 3Health News:Food Odors Linked With Lifespan in Fruit Flies 4Health News:Food Odors Linked With Lifespan in Fruit Flies 5
Singe-pull lace design provides easy-on application to provide support and immobilization of the wrist while preserving finger mobility...
ManuTrain is an active wrist support that has optional features for increased stabilization....
... Bird and Cronin, ... manufacturer of Patient Footwear, ... Patient Care Products. Our ... highest quality and available ...
... Deviation Splint uses safe, mild to moderate ... deviation at the MP joints. Dorsal-based splint ... and ulnar polycentric hinges located at the ... Padded, malleable finger rings can be individually ...
Medicine Products: