Related Experiment Video
Updated: Aug 7, 2026

Behavioral Phenotyping of Murine Disease Models with the Integrated Behavioral Station (INBEST)
Published on: April 23, 2015
Computable phenotypes for research using real-world data: experiences from the NIH pragmatic trials collaboratory
Marisa L Conte1, Judith M Schlaeger2, Guilherme Del Fiol3
1Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI 48109, United States.
Objectives:
Embedded pragmatic clinical trials (ePCTs) are conducted as part of routine clinical care and therefore use data collected from real-world data sources, such as electronic health record systems and administrative claims. A common approach for using these types of data across all phases of trial conduct is to create a computable phenotype (an explicitly defined data query data, including specified data types, data codes, and logical parameters) to capture patients with a clinical condition, exposure, symptom, characteristic, treatment, or outcome of interest.
Materials And Methods:
The Electronic Health Record (EHR) Core Working Group of the NIH Pragmatic Trials Collaboratory captured the experiences of investigators in developing, adapting, and applying computable phenotype definitions in their studies.
Results:
Four case studies describe different approaches to developing and using computable phenotypes in pragmatic trials.
Discussion:
We recommend: (1) developing computable phenotypes as part of a team with multiple areas of expertise; (2) appropriate validation; (3) dissemination of salient details regarding phenotype creation; and (4) capturing and reporting any modifications made to phenotypes during the conduct of the trial.
Conclusion:
A range of issues and decisions influence how computable phenotypes are developed and used in pragmatic clinical trials. Multidisciplinary teams that understand the context of the data, including the reason the data are collected and potential sources of bias, are best suited for the development and validation of phenotypes for ePCTs.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Clinical Trials
There are four phases in a clinical trial. A phase one...
Data Collection by Experiments
An example of the experimental method is a public clinical trial...
Background and Environment Affect Phenotype
An example of how genetic background affects phenotype can be seen in horses. The Extension gene in horses is responsible for their coat color. A wild-type gene (EE) produces black pigment in the coat, while a mutant gene (ee) produces red pigment. A...
Pharmacogenomics: Identification of New Drug Targets
Polygenic Traits

