Related Experiment Video
Updated: Aug 7, 2025

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk
1Department of Clinical Research and Medical Science, Medtronic China, Beijing, China.
Introduction:
Worldwide medical device regulatory authorities increasingly rely on the benefit-risk ratio for decision-making. However, current benefit-risk assessment (BRA) methods are mostly descriptive, not quantitative.
Areas Covered:
We aimed to summarize the regulatory requirements of BRA, discuss the feasibility of adopting multiple criteria decision analysis (MCDA), and explore factors for optimizing the MCDA for quantitative BRA of devices.
Expert Opinion:
Regulatory organizations emphasize BRA in their guidance, and some recommend user-friendly worksheets to conduct qualitative/descriptive BRA. The MCDA is considered one of the most useful and relevant quantitative BRA methods by pharmaceutical regulatory agencies and the industry; the International Society for Pharmacoeconomics and Outcomes Research summarized the principles and good practice guidance of MCDA. We recommend optimizing the MCDA by considering the following unique characteristics of the device BRA: using data from state of the art as a control and clinical data from post-market surveillance and literature; considering the device's diverse characteristics when selecting controls; assigning weight according to type, magnitude/severity, and duration of benefits and risks; and including physician and patient opinions in the MCDA. This article is the first to explore using MCDA for device BRA and might lead to a novel quantitative BRA method for devices.
More Related Videos
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
07:05Operant Protocols for Assessing the Cost-benefit Analysis During Reinforced Decision Making by Rodents
Published on: September 10, 2018
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Hazard Ratio
For example, in a clinical trial...
Methods of Documentation VI: Case Management Model
For example, a patient with a chronic...
Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Decision Making: P-value Method
First, a specific claim about the population parameter is proposed. The claim is based on the research question and is stated in a simple form. Further, an opposing statement to the claim is also stated. These statements can act as null and alternative hypotheses: a null hypothesis would be a neutral statement while the alternative hypothesis can...
Receiver Operating Characteristic Plot