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

Perspective: validating surrogate markers--are we being naive?

V De Gruttola1, T Fleming, D Y Lin

  • 1Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA.

The Journal of Infectious Diseases
|February 1, 1997
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

Quadruple Burden of Young Child Malnutrition in the Children's Healthy Living Program, United States-Affiliated Pacific.

The Journal of nutrition·2026
Same author

Checking the Cox Proportional Hazards Model with Interval-Censored Data.

Journal of the American Statistical Association·2025
Same author

Semiparametric Regression Analysis of Interval-Censored Multi-State Data with An Absorbing State.

Journal of the American Statistical Association·2025
Same author

Multiancestry Genome-Wide Association Study of Early Childhood Caries.

Journal of dental research·2024
Same author

Maximum likelihood estimation for semiparametric regression models with interval-censored multistate data.

Biometrika·2024
Same author

Multi-ancestry Genome-Wide Association Study of Early Childhood Caries.

medRxiv : the preprint server for health sciences·2024
Same journal

Monitoring HLA-A2-restricted T cell responses and BCLA-specific serostatus during human latent Toxoplasma gondii infection suggests the implication of CD8+ T cells in parasite containment.

The Journal of infectious diseases·2026
Same journal

Cryptosporidiosis in Ptients with Inborn Errors of Immunity: Retrospective cohort study of the French National Reference Center (CEREDIH).

The Journal of infectious diseases·2026
Same journal

Type 3 fimbrial regulation underpins anti-MrkA immunotherapeutic efficacy in experimental Klebsiella pneumoniae infection.

The Journal of infectious diseases·2026
Same journal

Rationalising heterogeneity in Staphylococcus aureus bacteraemia: current progress and future goals.

The Journal of infectious diseases·2026
Same journal

Lineage dynamics and risk factors underlying serotype 4 invasive pneumococcal disease in Spain.

The Journal of infectious diseases·2026
Same journal

Tuberculosis in pregnancy: Challenges of immune protection.

The Journal of infectious diseases·2026
See all related articles

Evaluating biologic activity as surrogates for clinical outcomes in human immunodeficiency virus (HIV) research is challenging. Current metrics for assessing these surrogates are complex and require a deep understanding of drug mechanisms to avoid misinterpretation and ensure reliability.

Area of Science:

  • Biomedical research
  • Clinical trial design
  • Pharmacology

Background:

  • Clinical efficacy studies for new human immunodeficiency virus (HIV) therapies are difficult to conduct.
  • Biologic activity measures are increasingly used as surrogates for clinical endpoints in drug development.
  • Evaluating the reliability of these surrogate measures is crucial for accurate therapeutic assessment.

Purpose of the Study:

  • To analyze the challenges and interpretability of using biologic activity measures as surrogates for clinical endpoints.
  • To examine the criteria for assessing the reliability of surrogate measures in drug efficacy studies.
  • To highlight the impact of drug mechanisms on the validity of surrogate endpoints.

Main Methods:

  • Review of existing criteria for evaluating surrogate endpoints in clinical research.

Related Experiment Videos

  • Analysis of metrics used to assess the "net effect" of treatments on clinical outcomes.
  • Exploration of the role of drug mechanism understanding in interpreting surrogacy metrics.

    • Main Results:

    • Proposed metrics for evaluating surrogate reliability can be misinterpreted due to the multiplicity of drug action mechanisms.
    • A thorough understanding of all drug mechanisms is essential for direct interpretation of surrogacy metrics.
    • High uncertainty in surrogacy metrics persists unless treatment effects are large or sample sizes are substantial.

    Conclusions:

    • Interpreting biologic activity as a surrogate for clinical endpoints requires a comprehensive understanding of drug mechanisms.
    • Current metrics for assessing surrogacy are prone to misinterpretation without detailed mechanistic insight.
    • Reliable use of surrogate markers in HIV and other disease research necessitates careful validation and consideration of study design parameters.