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J Parkinsons Dis. 2015;5(3):581-94. doi: 10.3233/JPD-150570.

Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease.

Author information

1
Critical Path Institute, CAMD, Tucson, AZ, USA.
2
Nuffield Department of Clinical Neurosciences, University of Oxford, Neurology Department, Level 3, West Wing, John Radcliffe Hospital, Headley Way, Headington, Oxford, UK.
3
Scientific consultant, London, UK.
4
Henry Wellcome Building, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
5
University of Bristol, Canynge Hall, Bristol, UK.
6
US Food and Drug Administration (FDA), New Hampshire Avenue, Silver Spring, MD, USA.
7
EMA, 30 Churchill Place, Canary Wharf, London, UK.
8
U of Rochester Medical Center, Crittenden Blvd, Rochester, NY, USA.
9
Michael J Fox Foundation for Parkinson's Research, Seventh Avenue, New York, NY, USA.
10
Aston University and MIT, Aston University, Aston Triangle, Birmingham, Media Lab, Massachusetts Institute of Technology, Cambridge, MA, USA.
11
Sage Bionetworks, Seattle, WA, USA.
12
Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.
13
Department of Clinical Neuroscience, UCL Institute of Neurology, London, UK Department of Neurology, Royal Free Hospital, London, UK Neurology, National Hospital for Neurology, London, UK.
14
Institute of Neuroscience and Psychology, University of Glasgow, Scotland, UK.
15
National Institute of Neurological Disorders and Stroke (NINDS), Neuroscience Center, Bethesda, MD, USA.
16
Department of Psychiatry, University of Oxford Hospital, Warneford, Oxford, UK.
17
Department of Clinical Neurosciences, John Van Geest Centre for Brain Repair, University of Cambridge, E.D. Adrian Building, Forvie Site, Robinson Way, Cambridge, UK.
18
Independent Scientific & Medical Writer, Savits Drive, Elverson, PA, USA.
19
Institute of Neurodegenerative Diseases, Parkinson's Progression Markers Initiative, Suite 8B, New Haven, CT, USA.
20
Laboratory of Neuro Imaging, Keck School of Medicine of USC, University of Southern California, CA, USA.
21
Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.
22
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
23
Parkinson's UK, London, UK.

Abstract

Parkinson's disease is a complex heterogeneous disorder with urgent need for disease-modifying therapies. Progress in successful therapeutic approaches for PD will require an unprecedented level of collaboration. At a workshop hosted by Parkinson's UK and co-organized by Critical Path Institute's (C-Path) Coalition Against Major Diseases (CAMD) Consortiums, investigators from industry, academia, government and regulatory agencies agreed on the need for sharing of data to enable future success. Government agencies included EMA, FDA, NINDS/NIH and IMI (Innovative Medicines Initiative). Emerging discoveries in new biomarkers and genetic endophenotypes are contributing to our understanding of the underlying pathophysiology of PD. In parallel there is growing recognition that early intervention will be key for successful treatments aimed at disease modification. At present, there is a lack of a comprehensive understanding of disease progression and the many factors that contribute to disease progression heterogeneity. Novel therapeutic targets and trial designs that incorporate existing and new biomarkers to evaluate drug effects independently and in combination are required. The integration of robust clinical data sets is viewed as a powerful approach to hasten medical discovery and therapies, as is being realized across diverse disease conditions employing big data analytics for healthcare. The application of lessons learned from parallel efforts is critical to identify barriers and enable a viable path forward. A roadmap is presented for a regulatory, academic, industry and advocacy driven integrated initiative that aims to facilitate and streamline new drug trials and registrations in Parkinson's disease.

KEYWORDS:

Data standards; collaboration; data integration; privacy; quantitative disease progression; regulatory science

PMID:
26406139
PMCID:
PMC4887129
DOI:
10.3233/JPD-150570
[Indexed for MEDLINE]
Free PMC Article

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