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

Blood Transfusion01:15

Blood Transfusion

3.0K
Blood transfusion is a critical medical procedure that saves lives and treats various medical conditions. It involves transferring blood from a donor to a recipient. This process requires a thorough understanding of the ABO blood group system and its associated antigens and antibodies.
Blood Transfusion Overview
A blood transfusion is a medical procedure used to replace blood lost due to injury, surgery, or to treat conditions such as anemia or cancer. During a transfusion, donor blood is...
3.0K

You might also read

Related Articles

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

Sort by
Same author

Variable Selection for Illness-Death Processes Under Dual Observation Schemes.

Statistics in medicine·2026
Same author

Two-phase designs for biomarker studies when disease processes are under intermittent observation.

Biometrics·2026
Same author

Two-phase designs for cost-effective evaluation of cancer screening tests.

Biometrics·2026
Same author

The Design of Large-Scale Plasma Donation Trials.

Statistics in medicine·2025
Same author

Exploring the impact of conventional and targeted DMARDs on body weight in patients with PsA.

Rheumatology (Oxford, England)·2025
Same author

Variable Selection for Progressive Multistate Processes Under Intermittent Observation.

Statistics in medicine·2025

Related Experiment Video

Updated: May 2, 2026

Automated Analysis of Dynamic Ca2+ Signals in Image Sequences
06:49

Automated Analysis of Dynamic Ca2+ Signals in Image Sequences

Published on: June 16, 2014

17.3K

Group sequential analysis of marked point processes: Plasma donation trials.

Kecheng Li1, Richard J Cook1,2

  • 1Department of Statistics and Actuarial Science, University of Waterloo, ON, Canada.

Statistical Methods in Medical Research
|July 2, 2025
PubMed
Summary

This study presents a statistical design for plasma donation trials to ensure donor safety when evaluating new devices. It addresses variable donor contribution and outlines methods for sample size and interim monitoring.

Keywords:
Group sequential testingalpha spending functioncorrelated binary datageneralized estimating equationheterogeneityinterim analysisnon-inferiorityrobust covariancetransfusion trial design

More Related Videos

Microfluidic Flow Chambers Using Reconstituted Blood to Model Hemostasis and Platelet Transfusion In Vitro
10:25

Microfluidic Flow Chambers Using Reconstituted Blood to Model Hemostasis and Platelet Transfusion In Vitro

Published on: March 19, 2016

9.5K
A Microfluidic Flow Chamber Model for Platelet Transfusion and Hemostasis Measures Platelet Deposition and Fibrin Formation in Real-time
09:38

A Microfluidic Flow Chamber Model for Platelet Transfusion and Hemostasis Measures Platelet Deposition and Fibrin Formation in Real-time

Published on: February 14, 2017

13.9K

Related Experiment Videos

Last Updated: May 2, 2026

Automated Analysis of Dynamic Ca2+ Signals in Image Sequences
06:49

Automated Analysis of Dynamic Ca2+ Signals in Image Sequences

Published on: June 16, 2014

17.3K
Microfluidic Flow Chambers Using Reconstituted Blood to Model Hemostasis and Platelet Transfusion In Vitro
10:25

Microfluidic Flow Chambers Using Reconstituted Blood to Model Hemostasis and Platelet Transfusion In Vitro

Published on: March 19, 2016

9.5K
A Microfluidic Flow Chamber Model for Platelet Transfusion and Hemostasis Measures Platelet Deposition and Fibrin Formation in Real-time
09:38

A Microfluidic Flow Chamber Model for Platelet Transfusion and Hemostasis Measures Platelet Deposition and Fibrin Formation in Real-time

Published on: February 14, 2017

13.9K

Area of Science:

  • Medical device evaluation
  • Clinical trial design
  • Biostatistics

Background:

  • Plasma donation is vital for treating various medical conditions, including bleeding disorders and infections.
  • Ensuring donor safety during plasma collection is paramount, necessitating rigorous evaluation of donation devices.
  • Existing trial designs may not adequately account for variable donor participation, impacting statistical power.

Purpose of the Study:

  • To develop a robust statistical framework for plasma donation trials comparing new devices to standard ones.
  • To ensure adequate statistical power and donor safety in clinical trials for plasma collection devices.
  • To address the challenge of variable donor contribution in trial data analysis.

Main Methods:

  • Derivation of a sample size formula using generalized estimating equations and robust variance estimation.
  • Development of interim monitoring strategies employing group sequential designs and alpha spending functions.
  • Utilizing a robust covariance matrix for accurate treatment effect estimation across successive analyses.

Main Results:

  • A validated sample size formula designed for the complexities of plasma donation trials.
  • Established group sequential monitoring strategies tailored for robust variance estimation.
  • Demonstrated application of the design in a simulated plasma donation study focusing on hypotensive adverse events.

Conclusions:

  • The proposed statistical design effectively addresses variable donor contributions in plasma donation trials.
  • The developed methods ensure adequate power and facilitate interim safety monitoring for device evaluation.
  • This framework enhances the rigor and reliability of clinical trials for new plasma collection devices.