Related Experiment Video
Updated: May 26, 2026
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Improving adherence to research protocol drug exclusions using a clinical alerting system.
James J Cimino1, Lincoln Farnum, Gary E DiPatrizio
1Laboratory for Informatics Development, NIH Clinical Center, Bethesda, MD, USA.
AMIA ... Annual Symposium Proceedings. AMIA Symposium
|December 24, 2011
Summary
Electronic health record (EHR) systems can now warn prescribers about drug conflicts with research protocols. This method helps prevent subject harm and ensures research integrity by identifying excluded drugs.
Area of Science:
- Clinical Informatics
- Biomedical Research
- Pharmacovigilance
Background:
- Clinical research protocols frequently exclude specific drugs to ensure subject safety and data integrity.
- Nonadherence to these drug exclusion criteria can lead to adverse events, compromised study results, and subject disqualification.
- Existing electronic health record (EHR) systems lack robust mechanisms to automatically flag potential drug-protocol conflicts.
Purpose of the Study:
- To develop a generalizable method for leveraging EHR alerting functions to prevent drug order conflicts with research protocols.
- To enhance patient safety and research integrity by proactively identifying and warning prescribers about excluded medications.
Main Methods:
- Analyzed a sample of National Institutes of Health (NIH) clinical research protocols to determine the prevalence of drug exclusions.
- Developed a data model to represent drug exclusions and exemptions, integrating it with the NIH's Biomedical Translational Research Information System (BTRIS) terminology.
- Created a medical logic module (MLM) for EHR systems to match ordered drug terms against protocol-defined drug concepts.
Main Results:
- Fifty percent of sampled protocols contained specific drug exclusions.
- The developed data model effectively represented exclusion and exemption concepts.
- The MLM successfully detected orders for excluded drugs in a test environment, providing informative alerts to users regarding exclusion context and applicability.
Conclusions:
- Drug exclusions are common in research protocols, necessitating automated detection to prevent violations.
- The proposed approach, utilizing a medical logic module (MLM), knowledge base, and controlled terminology, effectively detects and prevents potential protocol violations.
- Further refinement of the MLM is recommended to incorporate additional exclusion parameters like timing and comorbidities for enhanced accuracy.
More Related Videos
07:31Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
Published on: May 15, 2020
08:46Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
Related Concept Videos
01:19Pharmacovigilance
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...
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...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
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, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
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...
01:11Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
01:11Clinical Trials: Overview
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...
01:26Pharmaceutical Poisoning: Potential Scenarios
Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...