Landmark 226 · Research infrastructure
Critical Path for Parkinson's
In short
A public-private consortium run by the Critical Path Institute pools patient-level data from studies and trials and builds regulator-recognised tools for trial design, of which the 2018 DAT-scan qualification is the best known.
- What it is
- Research infrastructure
- Outcome
- Confirmed and built on
- When
- 2015–2026
- Research lane
- Infrastructure & funding
- Last checked
- 20 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
Critical Path Institute (C-Path) and Parkinson's UK; C-Path thanks Parkinson's UK for its support in founding the consortium in 2015. Executive Director Diane Stephenson. C-Path's page now lists 17 industry members (including AbbVie, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme and UCB), 6 academic institutions and 9 nonprofits, with the EMA, FDA and NINDS as the three government and regulatory members. The Michael J. Fox Foundation, Parkinson's Foundation and Movement Disorder Society were named as members in earlier material; which nonprofits are on the current list was not checked.
What happened
- Pooled database. The Integrated Parkinson's Database harmonises de-identified patient-level data from observational studies and randomised trials, with over 600 variables and "thousands" of participants. C-Path says it has limited biomarker and genetic data and excludes digital-health data. PPMI (landmark 24) data were a core input.
- Regulatory work. The DAT-imaging enrichment qualification is in landmark 79: FDA letter of support 2015, EMA letter of support 7 October 2016, EMA qualification opinion 2018. In August 2026 C-Path announced a Journal of Parkinson's Disease paper behind an FDA letter of support for the seed amplification assay as a trial-selection biomarker (landmark 9); I read only the announcement.
- Trial simulation tool. A disease-progression model of the MDS-UPDRS lets sponsors simulate early-motor-PD trials with DAT-based enrichment, through a cloud-based interface. The page gives no release date or regulatory status for the tool.
Why it moved us toward a cure
Each failed trial (landmark 62 is one) taught the field something only if its data could be reused. Pooled data let designers estimate effect sizes, drop-out and variation before starting an expensive trial. Landmark 79 is the first output.
Outcome
Advanced as an enabler. No claim here that it has shortened any particular trial.
Sources
- C-Path, Critical Path for Parkinson's programme page
- Movement Disorders Society, "Critical Path for Parkinson's", 2023
- C-Path: EMA letter of support, 7 Oct 2016
- News-Medical, 25 Aug 2026, on the C-Path announcement about the seed-assay letter of support
- C-Path release, 26 Jul 2018
- Not yet verified: the number of participants in the database; the status of the simulation tool; which nonprofits are members today; the full 2026 member list (the page was read by summary).
- Programme page read 20 Oct 2026.
How it connects
Built on
- uses PPMI launches · 2010
Led to
- builds on DAT scans qualified for trials · 2015
- uses FDA letter of support for the seed assay · 2024