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

4.5K
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...
4.5K
Clinical Trials01:16

Clinical Trials

10.1K
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...
10.1K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

376
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,...
376
Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

833
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
833
Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

1.4K
Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.4K

You might also read

Related Articles

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

Sort by
Same author

Measurement of the Positive Muon Anomalous Magnetic Moment to 127 ppb.

Physical review letters·2025
Same author

Measurement of the Positive Muon Anomalous Magnetic Moment to 0.20 ppm.

Physical review letters·2023
Same author

Measurement of the Positive Muon Anomalous Magnetic Moment to 0.46 ppm.

Physical review letters·2021
Same author

Automatic Staging of Cancer Tumors Using AIM Image Annotations and Ontologies.

Journal of digital imaging·2019
Same author

Challenges in Medical Informatics. A Discipline Coming of Age.

Yearbook of medical informatics·2016
Same author

Challenges for Medical Informatics as an Academic Discipline: Workshop Report.

Yearbook of medical informatics·2016

Related Experiment Video

Updated: Jan 8, 2026

Evidence-based Knowledge Synthesis and Hypothesis Validation: Navigating Biomedical Knowledge Bases via Explainable AI and Agentic Systems
05:47

Evidence-based Knowledge Synthesis and Hypothesis Validation: Navigating Biomedical Knowledge Bases via Explainable AI and Agentic Systems

Published on: June 13, 2025

1.2K

Knowledge representation and tool support for critiquing clinical trial protocols.

D L Rubin1, J Gennari, M A Musen

  • 1Center for Health Care Evaluation, VA Palo Alto Health Care System, Palo Alto, CA, USA.

Proceedings. AMIA Symposium
|November 18, 2000
PubMed
Summary

We developed a protocol inspection and critiquing tool (PICASSO) to automatically evaluate clinical trial protocols. This tool helps standardize protocols and improve their quality by identifying procedural errors.

More Related Videos

Author Spotlight: Improving Radiation Therapy Access with Radiation Planning Assistant
05:18

Author Spotlight: Improving Radiation Therapy Access with Radiation Planning Assistant

Published on: October 6, 2023

1.8K
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

16.4K

Related Experiment Videos

Last Updated: Jan 8, 2026

Evidence-based Knowledge Synthesis and Hypothesis Validation: Navigating Biomedical Knowledge Bases via Explainable AI and Agentic Systems
05:47

Evidence-based Knowledge Synthesis and Hypothesis Validation: Navigating Biomedical Knowledge Bases via Explainable AI and Agentic Systems

Published on: June 13, 2025

1.2K
Author Spotlight: Improving Radiation Therapy Access with Radiation Planning Assistant
05:18

Author Spotlight: Improving Radiation Therapy Access with Radiation Planning Assistant

Published on: October 6, 2023

1.8K
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

16.4K

Area of Science:

  • Clinical trial methodology
  • Medical informatics
  • Health services research

Background:

  • Clinical trial protocols are complex documents essential for study design and execution.
  • Manual authoring of protocols is time-consuming and prone to errors, increasing trial costs.
  • Ensuring protocol quality and adherence to best practices is critical for reliable research outcomes.

Purpose of the Study:

  • To introduce a novel tool, PICASSO (Protocol Inspection and Critiquing tool), for automated evaluation of clinical trial protocols.
  • To enhance the quality and standardization of clinical trial protocols through systematic inspection.
  • To reduce errors and inconsistencies in protocol content, thereby improving the efficiency and reliability of clinical trials.

Main Methods:

  • Developed a knowledge base encompassing medical domain information and clinical trial protocol requirements.
  • Created a formal language to define constraints representing appropriate clinical trial authoring practices.
  • Implemented the PICASSO tool to evaluate procedural aspects of clinical trial protocols against defined constraints.
  • Tested the methodology using a hypothetical protocol with both consistent and inconsistent designs.

Main Results:

  • PICASSO successfully identifies violations of defined constraints within clinical trial protocols.
  • The tool generates user messages and lists inconsistencies for each violated constraint.
  • Demonstrated the feasibility of using a knowledge base and formal constraints for protocol evaluation.

Conclusions:

  • The developed methodology and PICASSO tool offer a promising approach for standardizing and improving the quality of clinical trial protocols.
  • Automated protocol inspection can aid investigators and organizations in creating more robust and error-free trial designs.
  • This approach has the potential to reduce costs and enhance the overall integrity of clinical research.