Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale19:15

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

87.6K
The NICU Network Neurobehavioral Scale (NNNS) was developed as an assessment for the at-risk infant. The purpose of this article is to describe the NNNS, provide video examples of the NNNS procedures and discuss the ways in which the exam has been...
87.6K
Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

7.2K
Presented here is a protocol to examine consumer responses toward mass customization in the context of online retailing. The protocol details the online survey procedure and how to analyze data using structural equation modeling and group differences using latent mean...
7.2K
Benefits of Self-Esteem01:25

Benefits of Self-Esteem

186
Self-esteem—an individual's overall evaluation of their worth—plays a complex role in psychological functioning and well-being. It is often associated with many positive traits, such as confidence, optimism, and perseverance. Individuals with high self-esteem typically experience better sleep, manage peer pressure more effectively, and report greater life satisfaction. Conversely, low self-esteem has been consistently linked with increased risks of depression, anxiety, and poor...
186
Future Value01:11

Future Value

772
The future value (FV) concept is fundamental in finance as it reflects the time value of money. It shows how a current sum of money will grow over time at a specific interest rate. This principle helps investors understand potential investment growth, making it easier to compare different financial options.
Understanding future value offers several benefits. For example, it helps in making informed investment decisions. By projecting investment growth, individuals can compare financial products...
772
Establishment and Evaluation of a Risk Prediction Model for Pathological Escalation of Gastric Low-Grade Intraepithelial Neoplasia03:05

Establishment and Evaluation of a Risk Prediction Model for Pathological Escalation of Gastric Low-Grade Intraepithelial Neoplasia

1.5K
Here, we performed a systematic evaluation of patients diagnosed with gastric low-grade intraepithelial neoplasia by previous endoscopic biopsy and obtained a pathological diagnosis by complete resection of the lesion by endoscopic submucosal dissection (ESD), analyzing factors that potentially increase the risk of pathological...
1.5K
The Costs and Benefits of Natural Pedagogy05:59

The Costs and Benefits of Natural Pedagogy

5.6K
Source: Laboratories of Nicholaus Noles, Judith Danovitch, and Asheley Landrum—University of Louisville
Children have many tools they use over the course of development to learn from adults. Perhaps the earliest tool is imitation, simply copying what they see an adult do or say. However, children actually learn much more effectively than one might expect if they were only imitating. This is because, when it comes to learning and teaching, children and adults have a special relationship....
5.6K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.

Pharmacoepidemiology and drug safety·2025
Same author

Application of a Language Model Tool for COVID-19 Vaccine Adverse Event Monitoring Using Web and Social Media Content: Algorithm Development and Validation Study.

JMIR infodemiology·2024
Same author

Structured benefit-risk evaluation for medicinal products: review of quantitative benefit-risk assessment findings in the literature.

Therapeutic advances in drug safety·2020
Same author

Hypothesis-free signal detection in healthcare databases: finding its value for pharmacovigilance.

Therapeutic advances in drug safety·2019
Same author

Web-Based Signal Detection Using Medical Forums Data in France: Comparative Analysis.

Journal of medical Internet research·2018

Related Experiment Video

Updated: Jan 20, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
19:15

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

87.6K

Benefit-risk evaluation: the past, present and future.

Juhaeri Juhaeri1

  • 1Sanofi, Bridgewater, 55 Corporate Drive, Bridgewater, NJ 08807, USA.

Therapeutic Advances in Drug Safety
|September 7, 2019
PubMed
Summary

The evaluation of medicinal product benefit-risk (BR) profiles has evolved from subjective methods to structured, objective processes over the past 20 years. This shift enhances regulatory decision-making and patient safety.

Keywords:
benefit–riskmethodspatientpreferencequantitativestructuredweight

More Related Videos

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

7.2K
Author Spotlight: Advancing Early Detection and Treatment of Gastrointestinal Tumors
03:05

Author Spotlight: Advancing Early Detection and Treatment of Gastrointestinal Tumors

Published on: February 16, 2024

1.5K

Related Experiment Videos

Last Updated: Jan 20, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
19:15

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

87.6K
Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

7.2K
Author Spotlight: Advancing Early Detection and Treatment of Gastrointestinal Tumors
03:05

Author Spotlight: Advancing Early Detection and Treatment of Gastrointestinal Tumors

Published on: February 16, 2024

1.5K

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Regulatory Science
  • Pharmaceutical Policy

Background:

  • Historically, benefit-risk (BR) assessment of medicinal products was unstructured and subjective.
  • This led to inconsistencies in evaluating drug safety and efficacy.
  • A need for a more standardized approach became evident.

Purpose of the Study:

  • To describe the historical evolution of benefit-risk (BR) evaluation methodologies for medicinal products.
  • To highlight pivotal events that have shaped the current BR assessment landscape.
  • To provide insights into the future direction of BR profiling.

Main Methods:

  • Historical analysis of regulatory practices and key milestones.
  • Review of scientific literature and policy documents.
  • Retrospective examination of the transition in BR assessment frameworks.

Main Results:

  • A significant shift towards structured and objective BR evaluation processes has occurred in the last two decades.
  • Key historical events have been identified as critical drivers of this transformation.
  • The evolution reflects an increasing emphasis on data-driven and consistent decision-making.

Conclusions:

  • The transition to structured benefit-risk (BR) assessment represents a major advancement in pharmaceutical regulation.
  • Continued evolution is expected, driven by new data sources and analytical methods.
  • This ongoing refinement aims to optimize therapeutic product safety and effectiveness.