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

Benefits of Self-Esteem01:25

Benefits of Self-Esteem

201
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...
201
Decision Making01:20

Decision Making

990
Decision-making is a fundamental cognitive process that involves evaluating alternatives and selecting among them. This process can range from simple choices, such as deciding what to wear, to complex decisions, like choosing a major in college or a career path. The complexity of the decision often dictates the approach we use, which can be broadly categorized into two types: automatic and controlled decision-making.
Automatic decision-making is fast, intuitive, and relies on gut feelings...
990
Relative Risk01:12

Relative Risk

2.2K
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...
2.2K
Decision Making: P-value Method01:09

Decision Making: P-value Method

7.0K
The process of hypothesis testing based on the P-value method includes calculating the P- value using the sample data and interpreting it.
First, a specific claim about the population parameter is proposed. The claim is based on the research question and is stated in a simple form. Further, an opposing statement to the claim  is also stated. These statements can act as null and alternative hypotheses:  a null hypothesis would be a neutral statement while the alternative hypothesis can...
7.0K
Factors Affecting the Risk of Infection01:26

Factors Affecting the Risk of Infection

13.5K
The hosts' susceptibility to infection depends on several factors. The integrity of the skin and mucous membranes helps protect the body against microbial attacks. When the skin is altered, the chance of infection, limb loss, and even death increases.
The integrity and count of the white blood cells help the body resist pathogens and fight infection. When impaired, it reduces the body's resistance to pathogens. The acidic pH levels of the gastrointestinal, genitourinary tracts, and skin...
13.5K
Characteristics of Practical Op Amps01:16

Characteristics of Practical Op Amps

869
A difference amplifier, a crucial component in numerous electronic devices, ideally amplifies only the difference-mode signal, which is the difference between two input signals. However, in practical circuits, the output voltage depends on both the differential gain and the common-mode gain.
The ratio of differential gain to the common-mode gain is defined as the common-mode rejection ratio (CMRR). This ratio quantifies the ability of operational amplifiers (op-amps) to reject common-mode...
869

You might also read

Related Articles

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

Sort by
Same author

Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study.

JACC. Advances·2026
Same author

Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism.

Drugs & aging·2025
Same author

Rationale and Design of a Study to Assess the Engagement and Usefulness of the Care4Today Connect Digital Health Application for Disease Management in Coronary Artery Disease and Peripheral Artery Disease (iPACE-CVD Study).

Clinical cardiology·2024
Same author

Planning Benefit-Risk Assessments Using Visualizations.

Therapeutic innovation & regulatory science·2023
Same author

Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure.

JACC. Heart failure·2023
Same author

Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

American heart journal·2023

Related Experiment Video

Updated: Feb 5, 2026

Operant Protocols for Assessing the Cost-benefit Analysis During Reinforced Decision Making by Rodents
07:05

Operant Protocols for Assessing the Cost-benefit Analysis During Reinforced Decision Making by Rodents

Published on: September 10, 2018

6.5K

Benefit-Risk Evaluation and Decision Making: Some Practical Insights.

Michael W Colopy1, C V Damaraju2, Weili He3

  • 11 Global Statistical Sciences, UCB BioSciences Inc, Research Triangle Park, NC, USA.

Therapeutic Innovation & Regulatory Science
|September 18, 2018
PubMed
Summary
This summary is machine-generated.

Quantitative benefit-risk tools help evaluate drugs and devices. Experts discussed improving these methods for clearer, more structured decision-making in pharmaceutical development.

Keywords:
benefit-riskmetricstrade-offsutilitiesweighting

More Related Videos

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

88.0K
Author Spotlight: A Focus on Standardized Salivary Gland Ultrasound Protocol in Connective Tissue Disease Research
07:25

Author Spotlight: A Focus on Standardized Salivary Gland Ultrasound Protocol in Connective Tissue Disease Research

Published on: October 13, 2023

5.4K

Related Experiment Videos

Last Updated: Feb 5, 2026

Operant Protocols for Assessing the Cost-benefit Analysis During Reinforced Decision Making by Rodents
07:05

Operant Protocols for Assessing the Cost-benefit Analysis During Reinforced Decision Making by Rodents

Published on: September 10, 2018

6.5K
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

88.0K
Author Spotlight: A Focus on Standardized Salivary Gland Ultrasound Protocol in Connective Tissue Disease Research
07:25

Author Spotlight: A Focus on Standardized Salivary Gland Ultrasound Protocol in Connective Tissue Disease Research

Published on: October 13, 2023

5.4K

Area of Science:

  • Biostatistics
  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • Quantitative benefit-risk assessment tools are crucial for evaluating pharmaceutical drugs and devices.
  • Variations in these tools' properties can complicate decision-making processes.
  • Expert perspectives from the Food and Drug Administration (FDA) and industry highlight current challenges.

Purpose of the Study:

  • To present insights from the 2012 American Statistical Association (ASA) Biopharmaceutical Section FDA-Industry Statistics Workshop.
  • To clarify benefit-risk terminology and pragmatic considerations in endpoint selection.
  • To compare weighting methods for assessing benefit-risk trade-offs and discuss information summarization for decision support.

Main Methods:

  • Review of expert discussions on benefit-risk assessment methodologies.
  • Comparison of different weighting techniques (ranking, utilities, risk tolerance).
  • Exploration of strategies for enhancing information interpretation and transparency.

Main Results:

  • Benefit-risk terminology needs clear distinctions for better understanding.
  • Endpoint selection requires careful consideration, differentiating assessment from trial analysis.
  • Weighting methods offer varying strengths for evaluating benefit-risk trade-offs.

Conclusions:

  • Benefit-risk methodologies are converging towards a unified, structured paradigm.
  • This unified approach aims to simplify the selection of endpoints, weights, and metrics.
  • The goal is to improve decision-making through enhanced transparency and interpretability in drug and device evaluation.