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

Clinical Trials: Overview01:11

Clinical Trials: Overview

3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K

You might also read

Related Articles

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

Sort by
Same author

Clinical Characteristics and Survival Outcomes in Patients With Small Cell Lung Cancer in Spain: An Analysis of the Thoracic Tumor Registry (2016-2025).

Archivos de bronconeumologia·2026
Same author

Understanding Late-Stage Clinical Trial Failure in Multiple Sclerosis: Insights from ClinicalTrials.gov.

Neuroepidemiology·2026
Same author

Prevalence of long-term breast cancer survivors. Should primary care have a more relevant role on follow-up?

BMC women's health·2026
Same author

AI for detecting paper mill papers.

BMJ (Clinical research ed.)·2026
Same author

Evaluating eight smoking metrics for modelling survival in non-small cell lung cancer.

Cancer epidemiology·2026
Same author

Incidence of second primary cancers in lung cancer survivors by oncological treatment: a nationwide prospective cohort study in Spain.

The Lancet regional health. Europe·2026

Related Experiment Video

Updated: Sep 17, 2025

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS
08:18

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS

Published on: December 26, 2015

17.5K

Silent protocol modifications in multiple sclerosis clinical trials: a registry-based cross-sectional study.

Alejandro Rivero-de-Aguilar1,2, Mónica Pérez-Ríos3,4,5, Joseph S Ross6,7,8

  • 1Department of Neurology, University Hospital Complex of Pontevedra, Pontevedra, Spain.

Therapeutic Advances in Neurological Disorders
|July 3, 2025
PubMed
Summary

Silent protocol changes in multiple sclerosis (MS) clinical trials are common, impacting result interpretation. Increased transparency in MS research is crucial for accurate understanding and application of findings.

Keywords:
clinical trialmultiple sclerosis

More Related Videos

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
08:22

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

8.2K
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
10:46

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data

Published on: December 9, 2015

10.8K

Related Experiment Videos

Last Updated: Sep 17, 2025

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS
08:18

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS

Published on: December 26, 2015

17.5K
Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
08:22

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

8.2K
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
10:46

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data

Published on: December 9, 2015

10.8K

Area of Science:

  • Clinical research methodology
  • Neurology
  • Pharmaceutical sciences

Background:

  • Protocol amendments in clinical trials require clear declaration to prevent bias.
  • Undisclosed changes can distort external validity and statistical power assessments.
  • Selective outcome reporting bias is a significant concern in published research.

Purpose of the Study:

  • To identify undisclosed protocol modifications in Phase III and IV clinical trials for multiple sclerosis (MS) drugs.
  • To analyze discrepancies between registered trial protocols and published findings.
  • To assess the prevalence of silent protocol changes in MS drug trials conducted between 2010 and mid-2023.

Main Methods:

  • Comparative analysis of trial data from ClinicalTrials.gov and peer-reviewed publications.
  • Systematic search of ClinicalTrials.gov, PubMed, EMBASE, and Google Scholar for relevant MS drug trials.
  • Extraction and comparison of trial design, eligibility criteria, primary outcomes, and sample size estimations.

Main Results:

  • High concordance observed for study arms, assignment, and randomization; lower for masking.
  • Significant discrepancies found in eligibility criteria (45.5% match, 25.1% omitted, 26.6% added).
  • Inconsistencies in primary outcomes (51.8% match, 48.2% inconsistent) and sample size (14 trials) were noted.

Conclusions:

  • Silent protocol modifications are prevalent in multiple sclerosis clinical trials.
  • These changes can impede the accurate interpretation and real-world applicability of research findings.
  • Enhanced transparency in MS clinical research reporting is essential.