CA SE STUDY NO. 1
Engaging Key Stakeholders by
Forming a Study Working Group
The Clinician Input Study (CIS-PD) is a trial sponsored by
The Michael J. Fox Foundation (MJFF) that seeks to assess
the impact of wearable and mobile app data on clinical
decision making for individuals with Parkinson’s disease (PD).
Participants logged information on symptoms and medications
via smartphone application; smartwatches collected movement
data. Over the course of the study, an online dashboard
allowed participants’ treating clinicians to assess the utility of
the patient-reported and movement data on clinical care
management. Computational scientists used the data to identify
movement signatures of PD, (i.e., movements specific to PD)
that are recognizable when an individual is wearing a smartwatch.
Representative(s)
+ + Patient Representatives
+ + Community Engagement
Representatives – MJFF
+ + Principal Investigator
+ + Project Managers – MJFF
Several factors contributed to the decision to form a study
working group, including the novelty of data collection methods,
the in-home study design and the impact on a variety of
stakeholders. The group’s goals were to identify and address
potential study off-ramps as well as study design successes.
To accomplish this, the working group included individuals
participating in, implementing, or affected by the outcomes
of the CIS-PD study. The table below lists the key stakeholder
representatives, their perspectives and the areas of study design
that their perspectives informed:
Key Areas for
Consideration
Perspective
+ + Those who would be
participating in the study + + Participant study burden
+ + Those who would be
implementing the study + + Trial team burden
+ + The Technology Platform Provider
+ + Study logistics
+ + Technology capabilities and
Imitations
+ + Data collection methods
+ + Computational Scientists
+ + Clinical endpoints
+ + The Data Management Unit
+ + Clinical Coordinators
+ + Patient Representatives
+ + Computational Scientists
+ + Those who would be affected
by study outcomes
+ + Value to and utility for clinical
care management
+ + Clinical Coordinators
The working group reviewed all study documents including the
research protocol, informed consent documents, case report
forms and procedure manuals. This review process revealed
that a series of the assessments proposed by the computational
6
Accelerating Clinical Trials: Best Practices for Recruitment and Retention
scientists was both lengthy and potentially burdensome
for patients and coordinators. Based on the working group
feedback, the protocol was refined to ensure that there was
balance between data collection and feasibility.