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Related Concept Videos

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

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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.
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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.
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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...
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An R-Based Landscape Validation of a Competing Risk Model
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Estimand in benefit-risk assessment.

Xinru Ren1, X Gregory Chen2, William Wang3

  • 1BARDS, MSD, P.R.C, Beijing, China.

Journal of Biopharmaceutical Statistics
|February 9, 2023
PubMed
Summary

This study applies the estimand framework to benefit-risk assessment (BRA) in clinical trials. It discusses the benefits and challenges of using this approach for better drug development communication.

Keywords:
Estimandbenefit-risk evaluationpatient-level BRApopulation-level BRA

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Area of Science:

  • Pharmacometrics
  • Clinical Trial Design
  • Regulatory Science

Background:

  • The International Council for Harmonisation E9(R1) guideline introduced the estimand framework to enhance sponsor-regulator communication in drug development.
  • A structured benefit-risk assessment (BRA) framework is crucial for facilitating communication among all stakeholders.
  • Current discussions on estimands primarily focus on single measures of treatment effect in clinical trials, lacking a systematic link to BRA.

Purpose of the Study:

  • To initiate a discussion on benefit-risk assessment (BRA) within the established estimand framework.
  • To explore the application of the estimand framework to the context of BRA in clinical trials.
  • To identify and discuss different approaches to BRA using estimand principles.

Main Methods:

  • Identifying and categorizing two distinct types of BRA approaches.
  • Summarizing and analyzing completed clinical trials through the lens of the estimand framework for BRA.
  • Qualitative discussion of the benefits and challenges associated with employing the estimand framework for BRA.

Main Results:

  • The paper proposes a novel application of the estimand framework to BRA.
  • Two types of BRA approaches are identified and discussed in the context of estimands.
  • Analysis of completed clinical trials demonstrates the practical application of estimand language in BRA.

Conclusions:

  • The estimand framework offers a valuable structure for conducting and discussing benefit-risk assessments.
  • Applying estimand principles to BRA can improve clarity and consistency in drug development evaluations.
  • Further exploration of the benefits and challenges is needed to fully integrate estimands into BRA practices.