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

Study Designs in Epidemiology01:20

Study Designs in Epidemiology

442
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
442
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

185
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
185
Clinical Trials01:16

Clinical Trials

9.3K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
9.3K
Study Design in Statistics01:15

Study Design in Statistics

9.2K
A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
9.2K
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
Pharmacovigilance01:19

Pharmacovigilance

1.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.0K

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

Improving the Quality of Dissemination Efforts at a Regional Nursing Leadership Conference.

Nursing administration quarterly·2025
Same journal

Covid-19 vaccine study pulled by US CDC is finally published.

BMJ (Clinical research ed.)·2026
Same journal

The doctor will post you now.

BMJ (Clinical research ed.)·2026
Same journal

RSV vaccination programme expanded to thousands more vulnerable people.

BMJ (Clinical research ed.)·2026
Same journal

Adult gender dysphoria services after the Levy review.

BMJ (Clinical research ed.)·2026
Same journal

Blood pressure and cholesterol levels between normal weight and obese adults have narrowed thanks to medications, study says.

BMJ (Clinical research ed.)·2026
Same journal

Amos review fallout: national maternity adviser demands answers over removal of "normal birth" harms.

BMJ (Clinical research ed.)·2026
See all related articles

Related Experiment Video

Updated: Sep 20, 2025

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
08:36

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Published on: April 19, 2024

715

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Rebecca J Williams1, Heather D Dobbins1, Tony Tse2

  • 1National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.

BMJ (Clinical Research Ed.)
|June 10, 2022
PubMed
Summary
This summary is machine-generated.

A new approach improves reporting for master protocol research programs (MPRPs) by using separate registration records for each substudy. This ensures clear, structured information and timely results reporting for complex clinical trials.

More Related Videos

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
07:50

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

16.0K
The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

1.4K

Related Experiment Videos

Last Updated: Sep 20, 2025

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
08:36

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Published on: April 19, 2024

715
A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
07:50

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

16.0K
The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

1.4K

Area of Science:

  • Clinical trial methodology
  • Biomedical research reporting standards

Background:

  • Master protocol research programs (MPRPs) present unique reporting challenges due to their complex, multi-substudy designs.
  • Existing trial registries and reporting systems are often designed for single-protocol studies, hindering effective MPRP data submission.

Purpose of the Study:

  • To describe a structured approach for reporting MPRPs that aligns with good reporting practices.
  • To facilitate clear communication of the overall master protocol and individual substudy designs.
  • To enhance the discoverability and accessibility of MPRP results.

Main Methods:

  • Qualitative analysis of existing reporting practices and challenges.
  • Review of master protocol research program characteristics and examples.
  • Development of a proposed reporting framework.

Main Results:

  • A novel reporting approach is proposed, utilizing separate registration records for each substudy within an MPRP.
  • This method accommodates the complexity of MPRPs, enabling structured reporting of substudy designs and results.
  • The approach supports clear, descriptive, and timely reporting of trial outcomes.

Conclusions:

  • The proposed reporting strategy enhances clarity and efficiency for master protocol research programs.
  • This approach is applicable across various trial registries and results databases, promoting global harmonization.
  • Further discussion and adoption are encouraged to improve the reporting of complex clinical trial programs.