Navigation Links
Statistical Challenges in Medical Device Trail Evaluation

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 or click on to download the materials.

Media Contact:

Jennifer Liu
Tel: +86-21-6157-3918
Fax: +86-21-6157-7299

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
11. ERISA Creates Benchmarking Challenges for Plan Sponsors
Post Your Comments:
(Date:11/30/2015)... 30, 2015  IBA Molecular North America, Inc. (IBAMNA), ... radiopharmaceuticals, announced that as of January 1, 2016, it ... The decision to rebrand the company reflects a refined ... as its close relationship with Zevacor Molecular.  Both IBAMNA ... Science (IHS). Peter Burke , Vice ...
(Date:11/30/2015)... , November 30, 2015 North ... and is expected to grow at a CAGR of 7.6% from ... was valued at USD 135.6 million in 2014, and is expected ... --> According to the new Market Research Report "North ... non-invasive), By End User (Hospitals, ambulatory care, others) - Analysis And ...
(Date:11/30/2015)... , Nov. 30, 2015  Kevin Smith ... Sensium Healthcare, a global pioneer in wireless monitoring ... Boston, MA , Mr. Smith will ... Sensium,s global commercial strategy.  He will also directly ... to build clinical evidence for SensiumVitals, the first ...
Breaking Medicine Technology:
(Date:11/30/2015)... , ... November 30, 2015 , ... At Grand Dental ... and convenient setting. , When you have dental problems, you need to turn to ... can effectively diagnose and treat your needs, a friendly dentist who counsels you on ...
(Date:11/30/2015)... ... , ... Using a combination of two blood sugar tests rather than a ... a new study by researchers at the School of Public Health at Georgia State ... of Blood Glucose Tests ,” published in Frontiers in Public Health, the researchers noted ...
(Date:11/30/2015)... ... November 30, 2015 , ... Newly ... out of Glen Ridge, NJ. He has both advanced training and considerable ... He is also an expert in cosmetic dentistry. He is an active ...
(Date:11/30/2015)... ... 2015 , ... International telepathology consultations can significantly improve patient ... Diagnostics researchers. Their review of more than 1,500 pathology cases submitted electronically ... significantly altered treatment plans for more than half of the cases in which ...
(Date:11/30/2015)... , ... November 30, 2015 , ... ”Dying Words: The ... be released on December 1, 2015, to coincide with World AIDS Day. The multi-media ... journalist who covered the AIDS epidemic as he was dying of the disease. , ...
Breaking Medicine News(10 mins):