scholarly journals Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan

2021 ◽  
Author(s):  
Kinue Nishioka ◽  
Tomomi Makimura ◽  
Akihiro Ishiguro ◽  
Takahiro Nonaka ◽  
Mitsune Yamaguchi ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision ◽  
Benefit Risk Assessment

The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream

2019 ◽  
Vol 53 (5) ◽  
pp. 630-638 ◽  
Author(s):  
Matthew Reaney ◽  
Elizabeth Bush ◽  
Mary New ◽  
Jean Paty ◽  
Aude Roborel de Climens ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Potential Role ◽  
Treatment Decision ◽  
Individual Level ◽  
Treatment Decision Making ◽  
Benefit Risk Assessment

scholarly journals Benefit–Risk Tradeoffs in Assessment of New Drugs and Devices

Circulation ◽  
2020 ◽  
Vol 142 (20) ◽  
pp. 1974-1988
Author(s):  
Sanjay Kaul ◽  
Norman Stockbridge ◽  
Javed Butler
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Aortic Valve ◽  
Antiplatelet Agents ◽  
The United States ◽  
New Drugs ◽  
Net Benefit ◽  
Nonvalvular Atrial Fibrillation ◽  
Qualitative Approaches ◽  
Benefit Risk Assessment

Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit–risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit–risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit–Risk Framework developed by the United States Food and Drug Administration; and quantitative approaches such as the numbers needed to treat for benefit and harm, the benefit–risk ratio, and Incremental Net Benefit. We give illustrative examples of benefit–risk evaluations using 4 treatment interventions including sodium glucose cotransporter 2 inhibitors in patients with type 2 diabetes; a direct antithrombin agent, dabigatran, for reducing stroke and systemic embolism in patients with nonvalvular atrial fibrillation; transcatheter aortic valve replacement in patients with symptomatic severe aortic valve stenosis; and antiplatelet agents vorapaxar and prasugrel for reducing cardiovascular events in patients at high cardiovascular risk. Regular applications of structured benefit–risk assessment, whether qualitative, quantitative, or both, enabled by easy-to-understand graphical presentations that capture uncertainties around the benefit–risk metric, may aid shared decision-making and enhance transparency of those decisions.

The Extension of Molecular and Computational Information to Risk Assessment and Regulatory Decision Making*

2006 ◽  
pp. 151-180 ◽  
Author(s):  
James Bus ◽  
Richard Canady ◽  
Tracy Collier ◽  
J William Owens ◽  
Syril Pettit ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

The use of risk assessment in regulatory decision making: Time for a review

1981 ◽  
Vol 1 (3) ◽  
pp. 264-276 ◽  
Author(s):  
John T. Barr ◽  
Donald H. Hughes ◽  
Robert C. Barnard
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

Initiating and Managing Risk Assessments within a Risk Analysis Framework: FDA/CFSAN'S Practical Approach

2004 ◽  
Vol 67 (9) ◽  
pp. 2058-2062 ◽  
Author(s):  
ROBERT L. BUCHANAN ◽  
SHERRI DENNIS ◽  
MARIANNE MILIOTIS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Risk Analysis ◽  
Risk Assessments ◽  
Analysis Framework ◽  
Regulatory Decision ◽  
Managing Risk ◽  
Risk Managers ◽  
The U.S

Management of risk analysis involves the integration and coordination of activities associated with risk assessment, risk management, and risk communication. Risk analysis is used to guide regulatory decision making, including trade decisions at national and international levels. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) formed a working group to evaluate and improve the quality and consistency of major risk assessments conducted by the Center. Drawing on risk analysis experiences, CFSAN developed a practical framework for initiating and managing risk assessments, including addressing issues related to (i) commissioning a risk assessment, (ii) interactions between risk managers and risk assessors, and (iii) peer review.

Risk assessment and regulatory decision making

1981 ◽  
Vol 19 ◽  
pp. 549-560 ◽  
Author(s):  
I.C. Munro ◽  
D.R. Krewski
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

Implementing a globally harmonized risk assessment‐based approach for regulatory decision‐making of crop protection products

2020 ◽  
Vol 76 (10) ◽  
pp. 3311-3315 ◽  
Author(s):  
Douglas C Wolf ◽  
Manoj Aggarwal ◽  
Michael Battalora ◽  
Ann Blacker ◽  
Shadia I Catalano ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Crop Protection ◽  
Regulatory Decision
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