Literature DB >> 25676387

Development of a unified clinical trial database for Alzheimer's disease.

Jon Neville1, Steve Kopko2, Steve Broadbent1, Enrique Avilés1, Robert Stafford1, Christine M Solinsky3, Lisa J Bain4, Martin Cisneroz1, Klaus Romero1, Diane Stephenson5.   

Abstract

INTRODUCTION: Data obtained in completed Alzheimer's disease (AD) clinical trials can inform decision making for future trials. Recognizing the importance of sharing these data, the Coalition Against Major Diseases created an Online Data Repository for AD (CODR-AD) with the aim of supporting accelerated drug development. The aim of this study was to build an open access, standardized database from control arm data collected across many clinical trials.
METHODS: Comprehensive AD-specific data standards were developed to enable the pooling of data from different sources. Nine member organizations contributed patient-level data from 24 clinical trials of AD treatments.
RESULTS: CODR-AD consists of control arm pooled and standardized data from 24 trials currently numbered at 6500 subjects; Alzheimer's Disease Assessment Scale-cognitive subscale 11 is the main outcome and specific covariates are also included. DISCUSSION: CODR-AD represents a unique integrated standardized clinical trials database available to qualified researchers. The pooling of data across studies facilitates a more comprehensive understanding of disease heterogeneity.
Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Alzheimer's disease; Clinical trials database; Data integration; Data standardization; Facilitated access; Placebo data

Mesh:

Year:  2015        PMID: 25676387     DOI: 10.1016/j.jalz.2014.11.005

Source DB:  PubMed          Journal:  Alzheimers Dement        ISSN: 1552-5260            Impact factor:   21.566


  14 in total

1.  Apolipoprotein E Genotype and Sex Risk Factors for Alzheimer Disease: A Meta-analysis.

Authors:  Scott C Neu; Judy Pa; Walter Kukull; Duane Beekly; Amanda Kuzma; Prabhakaran Gangadharan; Li-San Wang; Klaus Romero; Stephen P Arneric; Alberto Redolfi; Daniele Orlandi; Giovanni B Frisoni; Rhoda Au; Sherral Devine; Sanford Auerbach; Ana Espinosa; Mercè Boada; Agustín Ruiz; Sterling C Johnson; Rebecca Koscik; Jiun-Jie Wang; Wen-Chuin Hsu; Yao-Liang Chen; Arthur W Toga
Journal:  JAMA Neurol       Date:  2017-10-01       Impact factor: 18.302

Review 2.  Clinical Research Informatics: Supporting the Research Study Lifecycle.

Authors:  S B Johnson
Journal:  Yearb Med Inform       Date:  2017-09-11

3.  Do people with Alzheimer's disease improve with repeated testing? Unpacking the role of content and context in retest effects.

Authors:  Alden L Gross; Nadia Chu; Loretta Anderson; M Maria Glymour; Richard N Jones
Journal:  Age Ageing       Date:  2018-11-01       Impact factor: 10.668

4.  Disease Progression Modeling: Key Concepts and Recent Developments.

Authors:  Sarah F Cook; Robert R Bies
Journal:  Curr Pharmacol Rep       Date:  2016-08-15

Review 5.  New Frontiers in Parkinson's Disease: From Genetics to the Clinic.

Authors:  Lamya S Shihabuddin; Patrik Brundin; J Timothy Greenamyre; Diane Stephenson; S Pablo Sardi
Journal:  J Neurosci       Date:  2018-10-31       Impact factor: 6.167

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

Authors:  Diane Stephenson; Michele T Hu; Klaus Romero; Kieran Breen; David Burn; Yoav Ben-Shlomo; Atul Bhattaram; Maria Isaac; Charles Venuto; Ken Kubota; Max A Little; Stephen Friend; Simon Lovestone; Huw R Morris; Donald Grosset; Margaret Sutherland; John Gallacher; Caroline Williams-Gray; Lisa J Bain; Enrique Avilés; Ken Marek; Arthur W Toga; Yafit Stark; Mark Forrest Gordon; Steve Ford
Journal:  J Parkinsons Dis       Date:  2015       Impact factor: 5.568

Review 7.  Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.

Authors:  Stephen P Arnerić; Richard Batrla-Utermann; Laurel Beckett; Tobias Bittner; Kaj Blennow; Leslie Carter; Robert Dean; Sebastiaan Engelborghs; Just Genius; Mark Forrest Gordon; Janice Hitchcock; June Kaplow; Johan Luthman; Richard Meibach; David Raunig; Klaus Romero; Mahesh N Samtani; Mary Savage; Leslie Shaw; Diane Stephenson; Robert M Umek; Hugo Vanderstichele; Brian Willis; Susan Yule
Journal:  J Alzheimers Dis       Date:  2017       Impact factor: 4.472

8.  Accelerating drug development for Alzheimer's disease through the use of data standards.

Authors:  Jon Neville; Steve Kopko; Klaus Romero; Brian Corrigan; Bob Stafford; Elizabeth LeRoy; Steve Broadbent; Martin Cisneroz; Ethan Wilson; Eric Reiman; Hugo Vanderstichele; Stephen P Arnerić; Diane Stephenson
Journal:  Alzheimers Dement (N Y)       Date:  2017-04-15

9.  The WorldWide Antimalarial Resistance Network Clinical Trials Publication Library: A Live, Open-Access Database of Plasmodium Treatment Efficacy Trials.

Authors:  Junko Takata; Paul Sondo; Georgina S Humphreys; Rebekah Burrow; Brittany Maguire; Mohammad S Hossain; Debashish Das; Robert J Commons; Ric N Price; Philippe J Guerin
Journal:  Am J Trop Med Hyg       Date:  2020-05-07       Impact factor: 2.345

10.  Global Standards to Expedite Learning From Medical Research Data.

Authors:  Lynn D Hudson; Rebecca D Kush; Eileen Navarro Almario; Nathalie Seigneuret; Tammy Jackson; Barbara Jauregui; David Jordan; Ronald Fitzmartin; F Liz Zhou; James K Malone; Jose Galvez; Lauren B Becnel
Journal:  Clin Transl Sci       Date:  2018-04-26       Impact factor: 4.689

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