Objective: To provide a progress update on the Critical Path for Parkinson’s (CPP) consortium’s “Digital Drug Development” (3DT) initiative, which was established in 2019 with the goal to advance the regulatory maturity of digital health technology (DHT) use in Parkinson’s disease (PD) clinical research.

Background: CPP’s 3DT initiative brings together relevant stakeholders including people with PD to collaborate pre-competitively under advisement of regulatory agencies worldwide. Work to date has leveraged the WATCH-PD study, a 12-month longitudinal multi-center study that evaluates DHT in people with early, untreated PD. All data from the WATCH-PD study is shared with 3DT members to advance the use and regulatory maturity of DHTs in a data-driven manner. Formal and informal interactions with regulatory agencies have provided feedback that served as a primary focus of the work completed by the 3DT team to date.

Method: 3DT organized formal scientific advisory meetings with the FDA and EMA to discuss the design of the WATCH-PD study.

Results: 3DT acted upon the advice of the regulatory agencies by creating workgroups consisting of content experts. Actionable items included:
Funding an additional cohort of age- and gender-matched control subjects for the WATCH-PD study to understand variation in DHT measures relative to normal variation.
Setting up workstreams to address key challenges identified by regulators:
Develop recommendations for privacy and security best practices.
Develop a framework for metadata standards to allow for interoperability of device platforms and comparability of DHT data.
Identify sources of variability in hardware, analysis, and user use of digital device data.
Presenting recommendations for engaging patients in DHT trials in a public forum.
Developing a qualitative study among WATCH-PD PD participants to relate experiences of daily living to DHT-based measures to establish content validity.

Conclusion: CPP’s 3DT initiative has addressed many of the main issues that were raised by international health regulators. While DHTs hold great promise for assessing concepts of interest relevant to people with PD in clinical trials, from a regulatory and evidentiary perspective these tools are still in early stages for use. CPP’s 3DT initiative with its core competencies in data- and regulatory science is uniquely poised to address these challenges to move the field forward more rapidly.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-progress-update-on-the-critical-path-for-parkinsons-consortiums-pre-competitive-3dt-initiative/