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