Jove
Visualize
Contact Us

Related Experiment Videos

Data handling in clinical trials: an ongoing debate

P J Jongen1

  • 1European Charcot Foundation, Institute for Neurology, University Hospital Nijmegen, The Netherlands.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|January 1, 1995
PubMed
Summary

This study emphasizes ethical data handling in clinical trials, advocating for independent monitoring boards, data analysis in separate institutions, and transparent publication of all results. It calls for enhanced corporate responsibility and investigator involvement to improve data integrity and practice implementation.

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

Longitudinal determinants of employment status in people with relapsing-remitting multiple sclerosis.

IBRO neuroscience reports·2024
Same author

Personality traits are not associated with changes in employment status over 3 years in persons with multiple sclerosis.

Multiple sclerosis journal - experimental, translational and clinical·2022
Same author

Subjective cognitive impairment is related to work status in people with multiple sclerosis.

IBRO neuroscience reports·2022
Same author

MSmonitor-plus program and video calling care (MPVC) for multidisciplinary care and self-management in multiple sclerosis: study protocol of a single-center randomized, parallel-group, open label, non-inferiority trial.

BMC neurology·2022
Same author

Work difficulties in people with multiple sclerosis: The role of anxiety, depression and coping.

Multiple sclerosis journal - experimental, translational and clinical·2022
Same author

Self-reported occupational functioning in persons with relapsing-remitting multiple sclerosis: Does personality matter?

Journal of the neurological sciences·2021
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

Area of Science:

  • Clinical Trials
  • Medical Ethics
  • Data Management

Background:

  • Effective data handling is essential for the integrity and ethical conduct of controlled clinical trials.
  • Current Good Clinical Practice guidelines may require modifications to ensure comprehensive data management.
  • Ethical principles must underpin all aspects of data handling, from collection to publication.

Purpose of the Study:

  • To define and advocate for a broader scope of data handling in clinical trials, including monitoring, analysis, and publication.
  • To propose ethical modifications to existing Good Clinical Practice guidelines.
  • To outline responsibilities for sponsors, investigators, and regulatory bodies in ensuring robust data handling.

Main Methods:

  • Discussion of ethical principles related to data handling.

Related Experiment Videos

  • Review and suggested modifications of Good Clinical Practice guidelines.
  • Argument for independent Data and Safety Monitoring Boards (DSMBs).
  • Advocacy for data analysis in independent institutions and mandatory interim analyses.
  • Emphasis on raw data accessibility for researchers and institutions.
  • Promotion of publishing both positive and negative trial results.

    • Main Results:

    • Independent Data and Safety Monitoring Boards (DSMBs) are crucial for corporate responsibility in data monitoring.
    • Data analysis should be conducted independently, with interim analyses being a moral obligation.
    • Full data accessibility and publication of all findings (positive and negative) are ethically mandated.
    • Commercial sponsors should implement initiatives for independent DSMBs, interim analysis, and data availability.
    • Investigators can enhance data handling quality through an Investigators Liaison Panel.

    Conclusions:

    • Implementing independent monitoring, analysis, and transparent publication is vital for ethical clinical trial data handling.
    • Clear contractual agreements and investigator-sponsored panels are necessary to ensure sponsor and investigator accountability.
    • Ethics committees and regulatory agencies must ensure that trial findings translate into improved clinical practice.