Packaging Design for Remote Clinical Trial Operations
Name
noh-jnoh-mng-meche-2023-thesis.pdf
Description
Thesis PDF
Size
12.02 MB
Format
Adobe PDF
Checksum (MD5)
4a4aaa665e62c9793f505ee04d426d5b
Author(s)
Noh, Joyce
Advisor(s)
Anthony, Brian W.
Date Issued
June 2023
Publisher
Massachusetts Institute of Technology
Abstract
As remote clinical trials continue to revolutionize the old-fashioned clinical trials model and increase patient enrollment, it has become apparent that there is no regulatory framework in place to standardize their utilization. In traditional clinical studies, there is very little independent user control and, therefore, error as a designated clinician performs all physiological measurements on each subject in person. However, in remote clinical settings, there is an added component of having to collect each participant’s physiological data and other necessary information over distance. This introduces the need for a “trial in a box” or remote clinical trial kits. Both the participant and the facilities in charge of the kits play a role in how these kits need to be designed, manufactured, and handled. However, there is a clear lack in the standardization of kit design.
This project provides a framework for human-subjects researchers to establish their own remote clinical trial operations. This thesis, specifically, focuses on designing the clinical trial kits that could be used for the trials mentioned in this case while also detailing design decisions in order to standardize kit design for other remote clinical trials.
MIT Department
Massachusetts Institute of Technology. Department of Mechanical Engineering
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