March 10, 2017
Pointe Hilton Tapatio Cliffs Resort | Phoenix, AZ
Overview and Objectives
The Coalition Against Major Diseases (CAMD), a consortium within the Critical Path Institute, is focused on accelerating the regulatory sciences required to advance innovative treatments for Alzheimer Disease and related neurodegenerative diseases with impaired cognition and function.
In collaboration with The Clinical Data Interchange Standards Consortium (CDISC), CAMD will sponsor a workshop to advance the understanding of the data standards required to integrate data across clinical drug trials using mobile device technologies.
The objectives of the meeting are:
- Review the existing standards that apply to mobile devices that could be implemented in clinical drug trials and longitudinal disease progression studies;
- Identify/prioritize existing gaps;
- Develop a plan to accelerate the creation/implementation of CDISC standards required for future registration studies that assess mobility, sleep and cognitive
performance;
Notes and action items from the meeting
Meeting Agenda
| Continental Breakfast | |
|
8:00 – 8:15 am |
Advancing CDISC Standards for BMD Use in Clinical Development of Neurological Treatments Stephen P. Arnerić (Critical Path Institute) |
|
8:15 – 8:30 am |
CDISC Standards & Digital Health Michael Ibara (CDISC) |
|
8:30 – 9:00 am |
Data Flow: From COIs to Data Archiving Barrie Nelson (CDISC) |
| 9:00 – 9:15 am |
Representing Device Data Using CDISC Standards Jon Neville (Critical Path Institute) |
| 9:15 – 9:35 am | Break |
| SESSION I: Sleep | |
|
9:35 – 10:05 am |
BMDs for Sleep Rebecca Spencer (University of Massachusetts) – 20 min. |
|
10:05 – 11:15 am |
Capturing Key COIs & Data Flow Barrie Nelson & Rebecca Spencer |
|
11:15 – Noon |
Lunch |
| SESSION II: Mobility | |
| Noon – 12:30 pm |
BMDs for Mobility/Frailty Ray Dorsey (University of Rochester) – 20 min. |
|
12:30 – 1:30 pm |
Capturing Key COIs & Data Flow Barrie Nelson & Lynn Hudson |
| SESSION III: Cognition | |
| 1:30 – 2:10 pm |
BMDs for Cognition Lee Ryan (University of Arizona) – 30 min. |
| 2:10 – 3:30 pm |
Key COIs & Data Flow Barrie Nelson & Lee Ryan |
| 3:30 – 3:50 pm | Break |
| 3:50 – 4:50 pm |
Summary and Next Steps Barrie Nelson, Jon Neville, Stephen Arnerić |
