Recent US Food and Drug Administration Efforts to Integrate the Patient's Perspective in Drug Development and Decision Making

2019 ◽  
Vol 105 (4) ◽  
pp. 789-791 ◽  
Author(s):  
Theresa Mullin ◽  
Pujita Vaidya ◽  
Meghana Chalasani
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Patient’S Perspective

scholarly journals Predicting Mortality with Applied Machine Learning: Can We Get There?

2019 ◽  
Vol 8 (1) ◽  
pp. 115-119
Author(s):  
Emily S. Patterson ◽  
C.J. Hansen ◽  
Theodore T. Allen ◽  
Qiwei Yang ◽  
Susan D. Moffatt-Bruce
Keyword(s):  
Machine Learning ◽  
Decision Making ◽  
Real Time ◽  
Drug Administration ◽  
Patient Population ◽  
Food And Drug Administration ◽  
Hospital Environment ◽  
Clinical Settings ◽  
Applied Machine Learning

There is growing interest in using AI-based algorithms to support clinician decision-making. An important consideration is how transparent complex algorithms can be for predictions, particularly with respect to imminent mortality in a hospital environment. Understanding the basis of predictions, the process used to generate models and recommendations, how to generalize models based on one patient population to another, and the role of oversight organizations such as the Food and Drug Administration are important topics. In this paper, we debate opposing positions regarding whether these algorithms are ‘ready yet’ for use today in clinical settings for physicians, patients and caregivers. We report voting results from participating audience members in attendance at the conference debate for each of these positions obtained real-time from a smartphone-based platform.

scholarly journals A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

2020 ◽  
Vol 109 (1) ◽  
pp. 123-130
Author(s):  
Lingshan Wang ◽  
Kimberly Maxfield ◽  
Daphne Guinn ◽  
Rajanikanth Madabushi ◽  
Issam Zineh ◽  
...  
Keyword(s):  
Drug Development ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Development Programs ◽  
Systematic Assessment
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