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

Design Example: Analyzing Capacity Contours for Flood Risk Assessment01:17

Design Example: Analyzing Capacity Contours for Flood Risk Assessment

66
Flood risk assessment involves careful planning and analysis to ensure the safety of communities near water retention structures. Capacity contours are a vital tool in this process, as they illustrate the potential spread of water at specific levels in a given area. In the context of building a bund across a small valley, these contours play a critical role in evaluating the safety of nearby residential areas.In this example, the bund is intended to store stormwater in the valley. The engineers...
66
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

147
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
147
Relative Risk01:12

Relative Risk

208
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
208
Survival Curves01:18

Survival Curves

194
Survival curves are graphical representations that depict the survival experience of a population over time, offering an intuitive way to track the proportion of individuals who remain event-free at each time point. These curves are widely used in fields such as medicine, public health, and reliability engineering to visualize and compare survival probabilities across different groups or conditions.
The Kaplan-Meier estimator is the most common method for constructing survival curves. This...
194
Hazard Ratio01:12

Hazard Ratio

154
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
154
Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

597
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
597

You might also read

Related Articles

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

Sort by
Same author

Statistical Practices of Safety Monitoring: An Industry Survey.

Therapeutic innovation & regulatory science·2018
Same author

[Kinase-Glo luminescent kinase assay for in vitro determination of PKA activity].

Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology·2012
Same author

Functional characterization of an arrestin gene on insecticide resistance of Culex pipiens pallens.

Parasites & vectors·2012
Same author

MiR-23a inhibits myogenic differentiation through down regulation of fast myosin heavy chain isoforms.

Experimental cell research·2012
Same author

Let-7b inhibits human cancer phenotype by targeting cytochrome P450 epoxygenase 2J2.

PloS one·2012
Same author

Role of IKK/NF-κB signaling in extinction of conditioned place aversion memory in rats.

PloS one·2012

Related Experiment Video

Updated: Jul 17, 2025

Facilitating the Analysis of Immunological Data with Visual Analytic Techniques
10:58

Facilitating the Analysis of Immunological Data with Visual Analytic Techniques

Published on: January 2, 2011

10.2K

Planning Benefit-Risk Assessments Using Visualizations.

Michael W Colopy1, Lovemore Gakava2, Chen Chen3

  • 1Statistical Sciences & Innovation, UCB Biosciences, Inc, 4000 Paramount Parkway Suite 200, Morrisville, NC, 27560, USA. michael.colopy@ucb.com.

Therapeutic Innovation & Regulatory Science
|September 8, 2023
PubMed
Summary
This summary is machine-generated.

A Benefit Risk Assessment Plan (BRAP) proactively outlines drug development assessments to ensure benefits outweigh risks. This article details a hypothetical BRAP example, guiding early-stage planning for investigational drugs.

Keywords:
Decision-makingMCDAPlanningTradeoffUncertainty

More Related Videos

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
07:31

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

Published on: May 15, 2020

7.1K
Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care
14:32

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care

Published on: February 16, 2011

23.7K

Related Experiment Videos

Last Updated: Jul 17, 2025

Facilitating the Analysis of Immunological Data with Visual Analytic Techniques
10:58

Facilitating the Analysis of Immunological Data with Visual Analytic Techniques

Published on: January 2, 2011

10.2K
Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
07:31

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

Published on: May 15, 2020

7.1K
Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care
14:32

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care

Published on: February 16, 2011

23.7K

Area of Science:

  • Drug development
  • Regulatory science
  • Clinical trial planning

Background:

  • A Benefit Risk Assessment Plan (BRAP) is crucial for evaluating investigational drugs.
  • Proactive planning is recommended over ad-hoc approaches for BRAPs.
  • Limited published guidance exists on constructing proactive BRAPs.

Purpose of the Study:

  • To illustrate the structure and content of a proactive Benefit Risk Assessment Plan (BRAP).
  • To provide a hypothetical example of a BRAP across the drug development lifecycle.
  • To highlight the importance of early assessments in the BRAP process.

Main Methods:

  • Development of a hypothetical drug development scenario.
  • Visualization of a series of planned assessments within a regulatory framework.
  • Integration of early assessments of medical conditions and current treatments.

Main Results:

  • The hypothetical BRAP integrates timelines and pre-specified assessments for decision milestones.
  • Early assessments identify key considerations for the investigational drug.
  • The example demonstrates a structured, proactive approach to benefit-risk evaluation.

Conclusions:

  • Proactive BRAP development is essential for efficient and informed decision-making in drug development.
  • Early-stage assessments within a BRAP are critical for identifying major benefit-risk considerations.
  • This article provides a practical framework for creating effective BRAPs.