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

Industry perspectives on ICH guidelines.

Frank W Rockhold1

  • 1SmithKline Beecham Pharmaceuticals R&D, 1250 South Collegeville Road, P.O. Box 5089, UP4130, Collegeville, Pennsylvania 19426-0989, USA. frank_w_rockhold@GSK.com

Statistics in Medicine
|September 27, 2002
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

SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

Lancet (London, England)·2026
Same author

Long-term safety of the Pfizer-BioNTech COVID-19 vaccine: Results from the HERO-together study.

Respiratory medicine·2026
Same author

Apolipoprotein E Mimetic Peptide CN-105 and Postoperative Delirium in Older Patients: The Phase 2 MARBLE Randomized Clinical Trial.

JAMA network open·2026
Same author

Additive prognostic value of functional performance to coronary artery anatomy: the ISCHEMIA trial.

European heart journal. Cardiovascular Imaging·2026
Same author

Determinants of publication likelihood and timeliness for clinical studies.

Journal of clinical and translational science·2026
Same author

Functional and Prognostic Implications of Different Iron Deficiency Definitions in Heart Failure: Insights From HEART-FID.

JACC. Heart failure·2025
Same journal

Interpretable Bayesian Modeling for Multireader Multicase Studies: Addressing Overdispersion and Limited Sample Size in Diagnostic Enhancement Evaluation.

Statistics in medicine·2026
Same journal

Adaptive Sequential Multiple Hypotheses Testing for Concomitant Vaccine Safety Surveillance.

Statistics in medicine·2026
Same journal

Novel Distance Regression for Repeated Outcomes With Missing Data: Applications to Longitudinal and Crossover Studies of Microbiome Beta-Diversity.

Statistics in medicine·2026
Same journal

Optimal Weighted Tests for Replication Studies and the 'Two-Trials Rule' With Multiple Hypotheses.

Statistics in medicine·2026
Same journal

Identifiable Copula-Double-Cox Models: A Fully Parametric Framework for Dependent Right-Censored Survival Data.

Statistics in medicine·2026
Same journal

Moving From Individualized Risk-Based Prevention to Benefit-Based Prevention: Estimating Individualized Life-Years Gained From Prevention Services as a Basis for Eligibility.

Statistics in medicine·2026
See all related articles

The International Conference on Harmonization (ICH) aims to standardize drug approval processes. Early adoption of ICH guidelines for clinical trials is crucial for global regulatory consistency and timely patient access to new medicines.

Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Affairs
  • Clinical Trials

Background:

  • Rising healthcare costs and R&D expenses necessitate efficient drug development.
  • Public demand for faster access to safe and effective treatments is increasing.
  • Limited resources of regulatory agencies require streamlined communication with sponsors.

Purpose of the Study:

  • To review International Conference on Harmonization (ICH) guidelines relevant to clinical trials.
  • To assess the progress and implementation challenges of ICH guidelines.
  • To emphasize the importance of guideline adoption for global drug registration.

Main Methods:

  • Review of published and in-development ICH guidelines.
  • Analysis of the historical context and objectives of the ICH initiative.

Related Experiment Videos

  • Focus on guidelines impacting clinical trial design and drug registration.

    • Main Results:

    • Significant progress has been made in developing ICH guidelines over ten years.
    • Implementation and maintenance of guidelines are in early stages globally.
    • Potential for regional drift in guideline application threatens harmonization goals.

    Conclusions:

    • Successful implementation of ICH guidelines is vital for achieving harmonization.
    • Consistent application of clinical trial guidelines is key to efficient drug registration.
    • Ongoing commitment is needed to ensure the long-term success of the ICH initiative.