TY - CHAP
T1 - Fully-Online, Interoperable Clinical Trial Management System for Multi-Interventional RCT
T2 - Maintain Your Brain Digital Platform
AU - Ginige, Jeewani Anupama
AU - Boulamatsis, Christos
AU - Heffernan, Megan
AU - San Jose, Juan Carlos
AU - Chuprov, Igor
AU - Chau, Tiffany
AU - Maeder, Anthony
AU - Valenzuela, Michael
AU - Fiatarone Singh, Maria
AU - Mavros, Yorgi
AU - Noble, Yian
AU - Radd-Vagenas, Sue
AU - Guerrero, Yareni
AU - Jain, Nidhi
AU - O'Leary, Fiona
AU - Kochan, Nicole
AU - Brodaty, Henry
PY - 2020/3/2
Y1 - 2020/3/2
N2 - Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.
AB - Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.
KW - Clinical Trial Management System
KW - digital trial platform
KW - interoperability
KW - multi-intervention trials
KW - online-interventions
UR - http://www.scopus.com/inward/record.url?scp=85081131898&partnerID=8YFLogxK
U2 - 10.3233/SHTI200009
DO - 10.3233/SHTI200009
M3 - Chapter
C2 - 32141882
AN - SCOPUS:85081131898
SN - 9781643680583
VL - 268
T3 - Studies in Health Technology and Informatics
SP - 97
EP - 112
BT - Information Technology Based Methods for Health Behaviours
A2 - Maeder, Anthony J.
A2 - Champion, Stephanie
A2 - Moores, Carly
A2 - Golley, Rebecca
PB - IOS PRESS
ER -