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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

110
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,...
110
Hazard Ratio01:12

Hazard Ratio

73
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...
73
Strategies for Assessing and Addressing Confounding01:25

Strategies for Assessing and Addressing Confounding

78
Confounding is a critical issue in epidemiological studies, often leading to misleading conclusions about associations between exposures and outcomes. It occurs when the relationship between the exposure and the outcome is mixed with the effects of other factors that influence the outcome. Given that, addressing confounding is of high importance for drawing accurate inferences in research.
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
78
Hazard Rate01:11

Hazard Rate

81
The hazard rate, also known as the hazard function or failure rate, is a statistical measure used to describe the instantaneous rate at which an event occurs, given that the event has not yet happened. From a probabilistic perspective, it represents the likelihood that a subject will experience the event in a very small time interval, conditional on surviving up to the beginning of that interval. In terms of frequency, the hazard rate can be viewed as the ratio of the number of events to the...
81
Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

113
Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and...
113
Statistical Methods for Analyzing Epidemiological Data01:25

Statistical Methods for Analyzing Epidemiological Data

275
Epidemiological data primarily involves information on specific populations' occurrence, distribution, and determinants of health and diseases. This data is crucial for understanding disease patterns and impacts, aiding public health decision-making and disease prevention strategies. The analysis of epidemiological data employs various statistical methods to interpret health-related data effectively. Here are some commonly used methods:
275

You might also read

Related Articles

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

Sort by
Same author

Validation of diagnostic codes for identifying chlamydial infections from TriNetX electronic health record data in the United States.

Sexually transmitted diseases·2026
Same author

Using the Consolidated Framework for Implementation Research (CFIR) to explore mutual-help group implementation challenges in college recovery programs.

BMC health services research·2026
Same author

Global Perspective on the Evolution and Future of Pharmacovigilance: Deliverables from the 24th Annual Meeting of the International Society of Pharmacovigilance Celebrating 25 Years of Excellence.

Drug safety·2026
Same author

"It's Just a Matter of Doing It": Women Veterans' Experiences with Changing Behavior for Cardiovascular Risk Reduction.

Journal of general internal medicine·2026
Same author

Risk of Fetal Exposure to Teratogenic Medications: Development of Evidence for the Teratogenic Risk Impact and Mitigation (TRIM) Tool.

Drug safety·2026
Same author

Correction: Reaching Veterans Most in Need: Evaluating Engagement in a National Telephone Lifestyle Coaching Program for Veterans.

Journal of general internal medicine·2026
Same journal

Implementation Aspects of a Medicines Shortage Policy Tool: Evidence from Australia's Serious Scarcity Substitution Instruments.

Drug safety·2026
Same journal

Availability and Communication of Risk Management Strategies for Pregnancy Category X Medicines across Australian Medicine Information Sources.

Drug safety·2026
Same journal

The Bidirectionality of Lawyer Reporting Bias in Disproportionality Analysis.

Drug safety·2026
Same journal

Safety of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A Longitudinal Analysis.

Drug safety·2026
Same journal

Developing a Hierarchical Algorithm to Identify Pregnancies and Determine Gestational Age from Nationwide Linked Health Data in Taiwan.

Drug safety·2026
Same journal

Safety and Effectiveness of Direct Oral Anticoagulants Versus Low-Molecular-Weight Heparin for Cancer-Associated Thrombosis: A Systematic Review and Meta-analysis.

Drug safety·2026
See all related articles

Related Experiment Video

Updated: May 22, 2025

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

2.0K

Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint.

Meredith Y Smith1,2, Rachel Davis3, Priya Bahri4

  • 1Evidera, Inc., 929 North Front Street, Wilmington, NC, 28401, USA. tantmieux57@gmail.com.

Drug Safety
|March 13, 2025
PubMed
Summary
This summary is machine-generated.

Evaluating risk minimization programs for medicines requires robust methods beyond surveys. This study demonstrates a mixed-methods approach using the PRISM framework to improve program evaluation rigor and inform regulatory decisions.

More Related Videos

Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods
13:04

Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods

Published on: September 19, 2012

12.0K
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

7.0K

Related Experiment Videos

Last Updated: May 22, 2025

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

2.0K
Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods
13:04

Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods

Published on: September 19, 2012

12.0K
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

7.0K

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Implementation Science
  • Health Services Research

Background:

  • Current evaluations of medicinal product risk minimization programs suffer from methodological limitations, often relying solely on surveys.
  • Regulatory bodies like the FDA and EMA now advocate for enhanced rigor through frameworks and mixed-methods designs.

Purpose of the Study:

  • To illustrate the application of a mixed-methods approach, guided by an implementation science framework, for designing risk minimization program evaluations.
  • To provide a practical example of how to enhance the evaluation of risk minimization strategies.

Main Methods:

  • The Practical, Robust, Implementation and Sustainability Model (PRISM) was selected as the guiding implementation science framework.
  • PRISM domains were mapped to EMA and FDA evaluation dimensions.
  • A mixed-methods evaluation design and data collection strategies were developed using a hypothetical risk minimization program case study.

Main Results:

  • Quantitative and qualitative measures for formative and summative evaluations were created, including survey and interview items.
  • Measures assessed contextual factors influencing program implementation and impact.
  • Outcomes evaluated included implementability, acceptability, reach, adoption, implementation, effectiveness, and maintenance.

Conclusions:

  • A mixed-methods approach, grounded in a recognized implementation science framework, facilitates comprehensive evaluations.
  • These evaluations provide essential data for regulatory decision-making regarding risk minimization programs.