Potential mechanisms of multimodal prehabilitation effects on surgical complications: a narrative review
Continuous advances in prehabilitation research over the past several decades have
clarified its role in improving preoperative risk factors, yet the evidence demonstrating …
clarified its role in improving preoperative risk factors, yet the evidence demonstrating …
Multi-criteria decision analysis for benefit-risk analysis by national regulatory authorities
O Chisholm, P Sharry, L Phillips - Frontiers in medicine, 2022 - frontiersin.org
The approval process for pharmaceuticals has always included a consideration of the trade-
offs between benefits and risks. Until recently, these trade-offs have been made in panel …
offs between benefits and risks. Until recently, these trade-offs have been made in panel …
[HTML][HTML] Quantitative benefit-risk assessment in medical product decision making: a good practices report of an ISPOR task force
T Tervonen, J Veldwijk, K Payne, X Ng, B Levitan… - Value in Health, 2023 - Elsevier
Benefit-risk assessment is commonly conducted by drug and medical device developers
and regulators, to evaluate and communicate issues around benefit-risk balance of medical …
and regulators, to evaluate and communicate issues around benefit-risk balance of medical …
Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review protocol
BDO Ascef, FC Gabriel, EA Suzumura… - BMJ open, 2023 - bmjopen.bmj.com
Background Benefit–risk assessment (BRA) is used in multiple phases along the health
technology's life-cycle to evaluate the balance between the benefits and risks, as it is …
technology's life-cycle to evaluate the balance between the benefits and risks, as it is …
A structured benefit-risk assessment operating model for investigational medicinal products in the pharmaceutical industry
T Sullivan, G Zorenyi, J Feron, M Smith… - Therapeutic Innovation & …, 2023 - Springer
Robust and transparent formal benefit-risk (BR) analyses for medicinal products represent a
means to better understand the appropriate use of medicinal products, and to maximize their …
means to better understand the appropriate use of medicinal products, and to maximize their …
[HTML][HTML] Suitability of preference methods across the medical product lifecycle: a multicriteria decision analysis
J Veldwijk, E de Bekker-Grob, J Juhaeri… - Value in Health, 2023 - Elsevier
Objectives This study aimed to understand the importance of criteria describing methods
(eg, duration, costs, validity, and outcomes) according to decision makers for each decision …
(eg, duration, costs, validity, and outcomes) according to decision makers for each decision …
[HTML][HTML] Illustrating emerging good practices for quantitative benefit-risk assessment: a hypothetical case study of systemic biologic treatments for plaque psoriasis
LG Lackey, X Ng, J Veldwijk, P Thokala, B Levitan… - Value in Health, 2023 - Elsevier
Objectives Quantitative benefit-risk assessment (qBRA) is a structured process to evaluate
the benefit-risk balance of treatment options to support decision making. The ISPOR qBRA …
the benefit-risk balance of treatment options to support decision making. The ISPOR qBRA …
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software
JH Woo, EC Kim, SM Kim - Expert Review of Medical Devices, 2022 - Taylor & Francis
ABSTRACT Introduction Artificial Intelligence (AI) is becoming increasingly utilized in the
medical device industry as it can address unmet demands in clinical sites and provide more …
medical device industry as it can address unmet demands in clinical sites and provide more …
A benefit risk approach in cutoff determination for diagnostic tests
J Mah, R Magari, KKW Lo, N Winden, G Xu - Clinica Chimica Acta, 2024 - Elsevier
A crucial step in the design of a diagnostic test is determining the cutoff point, the threshold
which separates a negative measurement from a positive one. The results of a diagnostic …
which separates a negative measurement from a positive one. The results of a diagnostic …
Available methods for benefit-risk assessment: Lessons for inflammatory bowel disease drugs
B Caron, F D'Amico, V Jairath, P Netter… - Journal of Crohn's …, 2023 - academic.oup.com
Abstract Background and Aims Medical treatment for inflammatory bowel disease has
advanced significantly over the two past decades. The advent of biologics and small …
advanced significantly over the two past decades. The advent of biologics and small …