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

4.7K
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...
4.7K
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.8K
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...
4.8K
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

303
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
303
Introduction to Language of Pathophysiology ll01:17

Introduction to Language of Pathophysiology ll

69
This lesson explores key terms that describe how diseases progress, their outcomes, and their distribution in populations.Diagnostic tests identify diseases and monitor treatment. These include blood and urine tests, biopsies, imaging (X-ray, MRI), and detection of infectious agents.Remission is a reduction or disappearance of symptoms.Exacerbation refers to the worsening of symptoms, such as increased wheezing during an asthma attack.A precipitating factor triggers an acute episode, while a...
69

You might also read

Related Articles

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

Sort by
Same author

Association between estimated glucose disposal rate and metabolic syndrome in older adults with sarcopenia.

Frontiers in nutrition·2026
Same author

Ultrafast Access to Indole-Fused Isocoumarin with Tunable Emission via Cascade Dual C-H/C-H Cross-Coupling.

Organic letters·2026
Same author

Silk fibroin/nano-hydroxyapatite scaffolds with graphene oxide induce macrophage M2 polarization and enhance angiogenesis to facilitate bone repair.

RSC advances·2026
Same author

Retraction Note: NSD2 targeting reverses plasticity and drug resistance in prostate cancer.

Nature·2026
Same author

Bio-hybrid nanovesicles with multimodal antioxidant and immunomodulatory functions attenuate acute kidney injury.

Journal of nanobiotechnology·2026
Same author

[Effects of <i>ZHU Lian</i>'s excitation-type acupuncture manipulation on limb function and serum oxidative stress indexes, angiogenic factors in patients with ischemic stroke during the recovery period].

Zhongguo zhen jiu = Chinese acupuncture & moxibustion·2026

Related Experiment Video

Updated: May 5, 2026

Determining the Likelihood of Variant Pathogenicity Using Amino Acid-level Signal-to-Noise Analysis of Genetic Variation
07:15

Determining the Likelihood of Variant Pathogenicity Using Amino Acid-level Signal-to-Noise Analysis of Genetic Variation

Published on: January 16, 2019

10.9K

Using Large Language Models for Advanced and Flexible Labelling of Protocol Deviations in Clinical Development.

Min Zou1, Leszek Popko2, Michelle Gaudio3

  • 1F.Hoffmann-La Roche AG, 4070, Basel, Switzerland. elaine.zou@roche.com.

Therapeutic Innovation & Regulatory Science
|May 13, 2025
PubMed
Summary

A novel large language model (LLM) approach automates protocol deviation (PD) classification, improving clinical trial efficiency. This method rapidly identifies impactful PDs, enhancing human subject protection and disease progression assessment in clinical development.

Keywords:
Good clinical practiceLarge language modelProtocol deviationsQuality assuranceStudy management

More Related Videos

Author Spotlight: Advancing Alzheimer's Research &#8211; Exploring Early Detection and Multi-Omics Approaches
09:47

Author Spotlight: Advancing Alzheimer's Research – Exploring Early Detection and Multi-Omics Approaches

Published on: December 15, 2023

916
Augmenting Large Language Models via Vector Embeddings to Improve Domain-Specific Responsiveness
03:14

Augmenting Large Language Models via Vector Embeddings to Improve Domain-Specific Responsiveness

Published on: December 6, 2024

466

Related Experiment Videos

Last Updated: May 5, 2026

Determining the Likelihood of Variant Pathogenicity Using Amino Acid-level Signal-to-Noise Analysis of Genetic Variation
07:15

Determining the Likelihood of Variant Pathogenicity Using Amino Acid-level Signal-to-Noise Analysis of Genetic Variation

Published on: January 16, 2019

10.9K
Author Spotlight: Advancing Alzheimer's Research &#8211; Exploring Early Detection and Multi-Omics Approaches
09:47

Author Spotlight: Advancing Alzheimer's Research – Exploring Early Detection and Multi-Omics Approaches

Published on: December 15, 2023

916
Augmenting Large Language Models via Vector Embeddings to Improve Domain-Specific Responsiveness
03:14

Augmenting Large Language Models via Vector Embeddings to Improve Domain-Specific Responsiveness

Published on: December 6, 2024

466

Area of Science:

  • Clinical Trial Management
  • Regulatory Science
  • Artificial Intelligence in Healthcare

Background:

  • Protocol deviations (PDs) are changes from study protocols, posing challenges in human subject protection due to inconsistent definitions and review processes.
  • Existing methods for identifying and trending impactful PDs are limited, despite industry efforts.
  • Traditional Natural Language Processing (NLP) methods for PD classification are cumbersome, necessitating advanced solutions.

Purpose of the Study:

  • To develop an automated, efficient, and flexible solution for classifying free-text protocol deviations.
  • To leverage Large Language Models (LLMs) for nuanced and context-aware PD classification.
  • To enable systematic trending and risk assessment of PDs across clinical programs.

Main Methods:

  • Utilized a Large Language Model (LLM), Meta Llama2, with a specifically designed prompt for classifying protocol deviations.
  • Applied the LLM to free-text data from a PD management system.
  • Analyzed model outputs to identify trends, assess risks, and support expert decision-making.

Main Results:

  • The LLM approach successfully flagged over 80% of PDs potentially impacting disease progression assessment.
  • Automated classification provided actionable insights in minutes, significantly reducing analysis time compared to manual methods.
  • Identified gaps in first-line controls, aiding process improvement for disease progression handling in trials.

Conclusions:

  • LLM-based automated classification offers a generalizable framework for efficient PD management in clinical development.
  • This approach enhances accuracy in disease progression assessment and supports better human subject protection.
  • The method facilitates process improvements by highlighting control gaps and enabling rapid risk identification.