eprintid: 10076682 rev_number: 16 eprint_status: archive userid: 608 dir: disk0/10/07/66/82 datestamp: 2019-06-26 15:00:40 lastmod: 2021-09-25 23:24:55 status_changed: 2019-06-26 15:00:40 type: article metadata_visibility: show creators_name: Romero, K creators_name: Conrado, D creators_name: Burton, J creators_name: Nicholas, T creators_name: Sinha, V creators_name: Macha, S creators_name: Ahamadi, M creators_name: Cedarbaum, J creators_name: Seibyl, J creators_name: Marek, K creators_name: Basseches, P creators_name: Hill, D creators_name: Somer, E creators_name: Gallagher, J creators_name: Dexter, DT creators_name: Roach, A creators_name: Stephenson, D creators_name: Critical Path for Parkinson's (CPP) Consortium, creators_name: Parkinson's Progression Markers Initiative (PPMI), title: Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease. ispublished: pub divisions: UCL divisions: B04 divisions: C05 divisions: F42 note: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. https://creativecommons.org/licenses/by/4.0/ abstract: The Critical Path for Parkinson's (CPP) Imaging Biomarker and Modeling and Simulation working groups aimed to achieve qualification opinion by the European Medicines Agency (EMA) Committee for Medical Products for Human Use (CHMP) for the use of baseline dopamine transporter neuroimaging for patient selection in early Parkinson's disease clinical trials. This paper describes the regulatory science strategy to achieve this goal. CPP is an international consortium of three Parkinson's charities and nine pharmaceutical partners, coordinated by the Critical Path Institute. date: 2019-05 date_type: published official_url: https://doi.org/10.1111/cts.12619 oa_status: green full_text_type: pub pmcid: PMC6510371 language: eng primo: open primo_central: open_green article_type_text: Journal Article verified: verified_manual elements_id: 1663113 doi: 10.1111/cts.12619 lyricists_name: Hill, Derek lyricists_id: DHILL80 actors_name: Cuccu, Clara actors_id: CCCUC40 actors_role: owner full_text_status: public publication: Clinical and Translational Science volume: 12 number: 3 pagerange: 240-246 event_location: United States issn: 1752-8062 citation: Romero, K; Conrado, D; Burton, J; Nicholas, T; Sinha, V; Macha, S; Ahamadi, M; ... Parkinson's Progression Markers Initiative (PPMI); + view all <#> Romero, K; Conrado, D; Burton, J; Nicholas, T; Sinha, V; Macha, S; Ahamadi, M; Cedarbaum, J; Seibyl, J; Marek, K; Basseches, P; Hill, D; Somer, E; Gallagher, J; Dexter, DT; Roach, A; Stephenson, D; Critical Path for Parkinson's (CPP) Consortium; Parkinson's Progression Markers Initiative (PPMI); - view fewer <#> (2019) Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease. Clinical and Translational Science , 12 (3) pp. 240-246. 10.1111/cts.12619 <https://doi.org/10.1111/cts.12619>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10076682/1/Romero_cts.12619.pdf