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 Experiment Videos

Clinical trial simulation in drug development.

Pascal Girard1, Michel Cucherat, David Guez

  • 1INSERM et EA 3738 Ciblage Thérapeutique en Oncologie, Faculté de Médecine Lyon-Sud, Lyon, France. Pascal.Girard@adm.univ-lyon1.fr

Therapie
|November 24, 2004
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

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

Sort by
Same author

Changes in estimands and prevalence of discrepancies in conclusions under the two-trial paradigm: a systematic review.

Journal of clinical epidemiology·2026
Same author

Spinal Epidural Abscess Complicated by Saddle Pulmonary Embolism: A Case Report.

JBJS case connector·2026
Same author

Lessons in IR: Gastric Variceal Embolization Complicated by Stroke.

Journal of vascular and interventional radiology : JVIR·2026
Same author

Risk of miscarriage after benzodiazepine use during pregnancy: updated systematic review and meta-analysis.

BMC pregnancy and childbirth·2026
Same author

Systematic Review and Meta-Analysis: Acetaminophen Use During Pregnancy and the Risk of Neurodevelopmental Disorders in Childhood.

Journal of the American Academy of Child and Adolescent Psychiatry·2025
Same author

Accounting for Misclassification of Binary Outcomes in External Control Arm Studies for Unanchored Indirect Comparisons: Simulations and Applied Example.

Statistics in medicine·2025

In silico therapeutic and clinical trial simulations aid drug development by creating virtual patients and treatments. These advanced modeling techniques can optimize experimental designs and reduce the cost and failure rates of clinical trials.

Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Computational Biology
  • Drug Development

Background:

  • Therapeutic modeling and clinical trial simulation are emerging techniques for drug discovery and predicting trial outcomes.
  • Advancements in 'in silico' models and nonlinear mixed-effect pharmacokinetic-pharmacodynamic (PK/PD) models have enabled sophisticated simulations.
  • These simulations allow for the creation of 'virtual' patients receiving simulated treatments or placebos.

Purpose of the Study:

  • To explore the applications of in silico therapeutic and clinical trial simulations in drug development.
  • To highlight the benefits of integrating these simulation approaches for optimizing experimental designs and decision analysis.
  • To identify the necessary steps for wider adoption of these methodologies in the pharmaceutical industry.

Related Experiment Videos

Main Methods:

  • Utilizing 'in silico' models for therapeutic simulations.
  • Employing nonlinear mixed-effect pharmacokinetic-pharmacodynamic (PK/PD) models.
  • Simulating 'virtual' patients and their responses to virtual treatments or placebos.

Main Results:

  • Simulations can be used for proof of concept, decision analysis, and optimization of experimental designs.
  • The impact of protocol deviations on clinical trial outcomes can be evaluated through simulation.
  • The pharmaceutical industry is increasingly using these techniques for optimizing Phase II and III trial designs.

Conclusions:

  • Wider adoption requires multidisciplinary efforts, development of new modeling and simulation tools, and established best practices.
  • Expected benefits include reduced failure rates, fewer negative trials, and decreased costs and duration of clinical development.
  • In silico therapeutic models are beginning to be used as a proof of concept in drug development.