Mobile Devices in Clinical Trials for Neurological Diseases: CDISC Standards Development

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

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

9:35 – 10:05 am

BMDs for Sleep

Rebecca Spencer (University of Massachusetts) – 20 min.
Derek Hill (IXICO) – 10 min.

10:05 – 11:15 am

Capturing Key COIs & Data Flow

Barrie Nelson & Rebecca Spencer

11:15 – Noon

SESSION II: Mobility
Noon – 12:30 pm

BMDs for Mobility/Frailty

Ray Dorsey (University of Rochester) – 20 min.
Jane Mohler (University of Arizona) – 10 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.
Jenny Barnett (Cambridge Cognition) – 10 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