Related Experiment Video
Updated: Dec 18, 2025
07:24
Home-Based Monitor for Gait and Activity Analysis
Published on: August 8, 2019
7.1K
Choosing a Mobile Sensor Technology for a Clinical Trial: Statistical Considerations, Developments and Learnings
Colleen Russell1, Marie McCarthy2, Joseph C Cappelleri3
1RussStat Consulting, LLC, 102 E Broadway Street #496, Prosper, TX, 75078, USA. RussStatConsulting@gmail.com.
Therapeutic Innovation & Regulatory Science
|June 20, 2020
Summary
Selecting mobile sensor technology (MST) for clinical trials requires careful consideration of technical specifications, verification, and regulatory status. This guide offers statistical methods for validating MST accuracy and combining data for reliable trial outcomes.
Area of Science:
- Clinical Trials Methodology
- Biomedical Engineering
- Health Informatics
Background:
- Mobile sensor technology (MST) offers potential for objective data collection in clinical trials.
- Standardized guidelines for selecting and validating MST in clinical research are needed.
- Previous work has not comprehensively addressed the multifaceted considerations for MST implementation.
Purpose of the Study:
- To outline key considerations for selecting MST in clinical trials.
- To detail requirements for technology specifications, verification, and regulatory compliance.
- To identify statistical methods for validating MST performance and data integration.
Main Methods:
- Review of current practices and expert consensus from the DIA Study Endpoints Community Working Group.
- Analysis of technological, regulatory, and statistical requirements for MST.
- Literature review and synthesis of existing resources on sensor technology in clinical research.
Main Results:
- Identified critical factors for MST selection: technology specifications, bench testing, and regulatory clearance.
- Proposed statistical approaches for assessing MST accuracy and precision against gold standards.
- Highlighted methods for combining data across different trials, data types, and device versions.
Conclusions:
- A systematic approach to MST selection is crucial for ensuring data integrity and trial success.
- Validation of MST against established clinical standards is essential for reliable evidence generation.
- Standardized methodologies will facilitate the broader adoption and effective use of MST in clinical trials.
Related Concept Videos
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
10.1K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
319
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,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
319