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

115
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,...
115
Assumptions of Survival Analysis01:15

Assumptions of Survival Analysis

86
Survival models analyze the time until one or more events occur, such as death in biological organisms or failure in mechanical systems. These models are widely used across fields like medicine, biology, engineering, and public health to study time-to-event phenomena. To ensure accurate results, survival analysis relies on key assumptions and careful study design.
86
Hazard Rate01:11

Hazard Rate

86
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...
86
Introduction To Survival Analysis01:18

Introduction To Survival Analysis

172
Survival analysis is a statistical method used to study time-to-event data, where the "event" might represent outcomes like death, disease relapse, system failure, or recovery. A unique feature of survival data is censoring, which occurs when the event of interest has not been observed for some individuals during the study period. This requires specialized techniques to handle incomplete data effectively.
The primary goal of survival analysis is to estimate survival time—the time...
172
Hazard Ratio01:12

Hazard Ratio

79
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...
79
Actuarial Approach01:20

Actuarial Approach

58
The actuarial approach, a statistical method originally developed for life insurance risk assessment, is widely used to calculate survival rates in clinical and population studies. This method accounts for participants lost to follow-up or those who die from causes unrelated to the study, ensuring a more accurate representation of survival probabilities.
Consider the example of a high-risk surgical procedure with significant early-stage mortality. A two-year clinical study is conducted,...
58

You might also read

Related Articles

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

Sort by
Same author

Dispensing of benzodiazepines and benzodiazepine-related drugs in Estonia, Latvia and Lithuania: a cross-national drug utilisation study.

Nordic journal of psychiatry·2026
Same author

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase.

British journal of clinical pharmacology·2026
Same author

Implementation of OMOP and ConcePTION Common Data Models in CPRD GOLD: Risk of Bleeding and Cardiovascular Outcomes From Anticoagulant Use.

Clinical pharmacology and therapeutics·2026
Same author

Impact of policy measures targeting benzodiazepines and Benzodiazepine-related drugs in Lithuania: interrupted time series analysis.

European journal of clinical pharmacology·2026
Same author

Through the lens of marketing authorization holders: experience in use of real-world data and real-world evidence in drug development and regulatory submissions in EU.

British journal of clinical pharmacology·2026
Same author

Strengthening Pharmacoepidemiology in a Changing Research Environment: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Pharmacoepidemiology and drug safety·2025

Related Experiment Video

Updated: May 31, 2025

Three Laboratory Procedures for Assessing Different Manifestations of Impulsivity in Rats
09:12

Three Laboratory Procedures for Assessing Different Manifestations of Impulsivity in Rats

Published on: March 17, 2019

9.4K

Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies.

Sharon C M Essink1,2, Inge M Zomerdijk2, Thomas Goedecke3

  • 1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

Clinical Pharmacology and Therapeutics
|January 24, 2025
PubMed
Summary
This summary is machine-generated.

Evaluating risk minimization measures (RMMs) effectiveness in post-authorization safety studies (PASSs) takes over four years. The longest delays occur between study request and initiation, highlighting a need for improved guidance and timely protocol submissions.

More Related Videos

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

5.9K
The Power of Interstimulus Interval for the Assessment of Temporal Processing in Rodents
10:27

The Power of Interstimulus Interval for the Assessment of Temporal Processing in Rodents

Published on: April 19, 2019

6.9K

Related Experiment Videos

Last Updated: May 31, 2025

Three Laboratory Procedures for Assessing Different Manifestations of Impulsivity in Rats
09:12

Three Laboratory Procedures for Assessing Different Manifestations of Impulsivity in Rats

Published on: March 17, 2019

9.4K
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

5.9K
The Power of Interstimulus Interval for the Assessment of Temporal Processing in Rodents
10:27

The Power of Interstimulus Interval for the Assessment of Temporal Processing in Rodents

Published on: April 19, 2019

6.9K

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Regulatory Science
  • Pharmaceutical Policy

Background:

  • Regulatory oversight of medicines requires robust evaluation of risk minimization measures (RMMs) effectiveness.
  • Post-authorization safety studies (PASSs) are crucial for assessing RMMs in real-world settings.
  • Understanding the timelines for RMM effectiveness studies can identify bottlenecks in the regulatory process.

Purpose of the Study:

  • To assess the time intervals between key regulatory milestones for RMM effectiveness studies.
  • To identify the most time-consuming phases in the evaluation of RMM effectiveness PASSs.
  • To provide insights for optimizing the RMM effectiveness assessment process.

Main Methods:

  • Retrospective analysis of completed RMM effectiveness PASSs assessed by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) between 2016 and 2022.
  • Extraction of regulatory document dates from EMA databases.
  • Calculation of time durations between study request, protocol assessment, study start, and final study report assessment.

Main Results:

  • The median duration from study request to final PRAC outcome for RMM effectiveness PASSs was 52 months (over 4 years).
  • The period from study request to study start averaged 21 months, representing a significant time lag.
  • Protocol assessment for studies with approved protocols took a median of 7 months.

Conclusions:

  • The overall timeline for evaluating RMM effectiveness PASSs significantly exceeds four years.
  • The pre-study phase (request to study start) is a major contributor to the extended duration.
  • Improving guidance and encouraging timely protocol submissions could expedite the evaluation of RMM effectiveness.