Objective: To describe the Critical Path for Parkinson’s (CPP) consortium approach to advance the field of digital technologies in clinical drug development for Parkinson’s disease (PD).

Background: PD therapies that intervene early in the disease process are urgently needed. One major challenge to developing such therapies is the paucity of sensitive, yet clinically interpretable tools that can capture meaningful aspects of the disease at the time of clinical diagnosis. Digital health technologies have the potential to advance the field by enabling the objective, remote and frequent measurement of PD signs and symptoms in natural environments and during activities that are meaningful to patients’ daily lives. For these technologies to have widespread drug development impact, a regulatory-aligned consensus is required on best practice in selecting appropriate technologies and in collecting and processing digital data aimed at monitoring disease progression.

Method: CPP consists of pharma companies, academic advisors, non-profit research organizations and regulatory agency representatives. New digital health technology activities have recently been initiated under CPP to advance the field of digital technologies in clinical drug development for Parkinson’s disease (PD).

Results: Three major digital health technology activities have recently been initiated under CPP. The first is an assessment of the landscape of currently available digital health technologies in PD drug development. The second is the collation of existing information from PD individuals regarding their experience using digital sensors. Third, A Digital Drug Development Tools (3DT) group has been created under the auspices of the CPP consortium 3DT is leveraging a recently initiated, prospective study called WATCH-PD (Wearable Assessments in The Clinic and Home in PD), a multicentre, prospective, longitudinal, digital assessment study of PD progression in subjects with early, untreated PD as exemplar pilot study to facilitate discussion and alignment with regulatory agencies on evidentiary considerations for digital assessments.

Conclusion: CPP aims encourage the sharing of positive and negative experiences with digital health technologies in PD and align with regulators early and often to maximize knowledge and minimize duplication of efforts.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/enabling-efficient-use-of-digital-health-technologies-to-support-parkinsons-disease-drug-development-through-precompetitive-collaboration/