To highlight the progress of Critical Path for Parkinson’s (CPP), a precompetitive consortium aiming to advance drug development tools for clinical trials targeting early stages of Parkinson’s.

CPP is a public-private partnership, led by the Critical Path Institute (C-Path), jointly funded by Parkinson’s UK and the pharmaceutical industry. CPP comprises a broad coalition of stakeholders, including industry members, regulatory agencies, academic experts and patient-advocacy groups.

Data sources for the CPP Integrated Database include: Parkinson’s Progression Markers Initiative (PPMI), the Cambridgeshire Parkinson's Incidence from GP to Neurologist (CamPaIGN) cohort, Oxford PD Centre (OPDC) Discovery Cohort, Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation - PD (ICICLE-PD) and Tracking Parkinson’s. Clinical trial data include Parkinson Research Examination of CEP-1347 Trial (PRECEPT), DATATOP and ADAGIO. Application of Parkinson’s specific CDISC standards supported the successful integration of patient-level data.

In the three years since the launch of CPP, the consortium has 1) developed a worldwide Parkinson’s integrated database consisting of patient-level data from >7300 individuals with Parkinson’s, 2) achieved a formal qualification opinion from the European Medicines Agency (EMA) for the use of Dopamine Transporter neuroimaging (DAT) as an enrichment biomarker for clinical trials targeting subjects soon after diagnosis, 3) formally engaged both FDA and EMA for regulatory acceptance of a PD disease progression model and 4) released a user friendly simulation tool focused on trial design using DAT biomarker for trial recruitment at baseline.

The CPP global database represents a unique resource to further drug development tools, including biomarkers, disease progression models, and trial simulations, for use in Parkinson’s clinical trials. Future strategies for the consortium are underway and include expanding the CPP database and evaluation of novel digital drug development tools for quantifying disease progression.