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, on 23-24 May in Shanghai.

Yang Ying , Director of Lead Technology, CRM, MicroPort Medical; Yao Jianqing , PhD, Senior Director of Research and Development, Zimmer; Li Luming , Chief Professor, School of Aerospace, Tsinghua University, as well as Chen Chunlin, Chief Physician & Professor, Obstetrics & Gynaecology, Department for Southern Medical University South Hospital and Guo Zhi , Chief Physician & Professor, Interventional Therapy Department, Tianjin Medical University Cancer Institute & Hospital, Tianjin Medical University Cancer Institute and Hospital (TMUCIH), will join together in this conference to share their predictions for and reflections on the medical application of future implants for orthopedics, cardiovascular and the brain, as well as on implantable and interventional materials' clinical trial evidence and analysis.

If you want to know more about the prospects for exploration into the new areas of implantable and interventional medical devices development, and in gaining new perspective on medical equipment management and clinical applications, please check www.iimd-china.com or click on http://www.iimd-china.com/Download.aspx?id=6&lang=en-us to download the materials.

Media Contact:

Jennifer Liu
Tel: +86-21-6157-3918
Fax: +86-21-6157-7299
Email: jennifer.liu@ubm.com


'/>"/>
SOURCE UBM Conferences
Copyright©2012 PR Newswire.
All rights reserved

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:3/23/2017)... 2017 Research and Markets has announced the ... Procedure, Replacement Procedure By Technique, Repair Procedure By Technique, By Region, ... ... is forecasted to grow at a CAGR of 13.35% during 2016-2021 ... by rising aging population, growth in population with heart disease and ...
(Date:3/23/2017)... March 23, 2017 ... created through extensive primary research (inputs from industry ... aims to present the analysis of global heart ... (Replacement and Repair); Replacement Procedure By Technique (Mechanical, ... Technique (Surgical Devices, Balloon Valvuloplasty, Transcatheter Mitral Valve ...
(Date:3/23/2017)... 23, 2017 As a result of ... the prevalence of allergic diseases, cutting edge developments ... revolutionising the ways in which pharmaceutical and biotech ... promises to be both a high quality meeting ... interest groups, immunologists, research scholars and doctors. The ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... The Radiology Business Management Association (RBMA) ... annual awards, now in their 12th year, are among the most prestigious in radiology ... 2016, the awards were retooled to recognize achievements in both large budget (over $5,000) ...
(Date:3/24/2017)... ... ... According to a new study by NCPA Senior Fellow John R. Graham, ... Congress has directed the CBO to follow. The CBO itself previously recognized Obamacare would ... estimates a reduction in employer-based coverage due to the GOP reform, which is not ...
(Date:3/24/2017)... ... ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce the opening ... is the group’s 7th location in San Antonio and 23rd in Texas. Dr. ... from the clinic, which opened March 22, 2017. , The team of ...
(Date:3/24/2017)... ... 24, 2017 , ... The iaedp Foundation, the premier provider of educational programs ... suffering from the full spectrum of disordered eating, announced today that the 2017 Symposium ... all 50 states and several countries converged on the Green Valley Resort in Las ...
(Date:3/24/2017)... ... 24, 2017 , ... Mlynarek Insurance Agencies, a Detroit area ... owners across eastern Michigan, is connecting with the Oxford/Orion FISH Food Pantry for ... The Oxford/Orion FISH Food Pantry works to ensure homeless, hungry, and underprivileged families ...
Breaking Medicine News(10 mins):