Critical Path for Parkinson’s Regulatory Successes and Community Impact
Regulatory endorsement relieves trial sponsors of the burden of having to convince the regulators that methods are reliable and reproducible and could accelerate effective patient treatments. Tools endorsed by regulators save time and money, which incentivizes more trials, which results in increased chances of getting more Parkinson’s disease treatments approved, and directly impacts people in need. View our regulatory successes and how they directly impact people with Parkinson’s below.
| Year | Agency | Type | Description | Link |
|---|---|---|---|---|
| 2015 | FDA | Letter of support | Exploratory prognostic biomarkers for enrichment in early-stage Parkinson's disease LINK clinical trials; molecular neuroimaging biomarker: dopamine trransporter | https://www.fda.gov/media/112637/download |
| 2016 | EMA | Letter of support | Molecular imaging of the dopamine transporter biomarker as an enrichment biomarker LINK for clinical trials for early Parkinson's disease | https://www.ema.europa.eu/en/documents/other/letter-support-molecular-imaging-dopamine-transporter-biomarker-enrichment-biomarker-clinical-trials_en.pdf |
| 2018 | EMA | Qualification opinion | Molecular neuroimaging of the dopamine transporter as biomarker to identify patients LINK with early manifest Parkinsonism in Parkinson's disease | https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-dopamine-transporter-imaging-enrichment-biomarker-parkinsons-disease-clinical_en.pdf |
| 2019 | FDA | Critical path innovation meeting | Digital drug development tools for early Parkinson’s disease clinical trials | |
| 2019 | EMA | Innovative task force | Digital drug development tools for early Parkinson’s disease clinical trials | |
| 2022 | EMA | Letter of support | Model-based clinical trial simulation platform to optimize design of efficacy evaluation LINK studies in Parkinson’s disease | https://www.ema.europa.eu/en/documents/other/letter-support-model-based-clinical-trial-simulation-platform-optimize-design-efficacy-evaluation_en.pdf |
| 2024 | FDA | Letter of Support | Enabling Clinical trials of Biologically defined Neuronal Synuclein disease: A Road to Prevention | https://www.fda.gov/media/181368/download?attachment |
Impact Videos
Sarah Zenner-Dolan: Living with Young Onset Parkinson's Disease
Changing the face of clinical trials for Parkinson’s
/spFlorence Pite Memorial Lecture, London, November 15, 2017
From our Founding Partner, Parkinson's UK: Accelerating Better Treatments in Years, Not Decades
Understanding the Drug Development Process: Explained by The Michael J. Fox Foundation
How NASA’s Space Simulations Mirror the Benefits of Clinical Trial Tools
Parkinson’s Through the Eyes of Carl Ames: A Patient’s Perspective
