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.
IntroductionThe exceedingly high rate of failed trials in Alzheimer's disease (AD) calls for immediate attention to improve efficiencies and learning from past, ongoing, and future trials. Accurate, highly rigorous standardized data are at the core of meaningful scientific research. Data standards allow for proper integration of clinical data sets and represent the essential foundation for regulatory endorsement of drug development tools. Such tools increase the potential for success and accuracy of trial results.MethodsThe development of the Clinical Data Interchange Standards Consortium (CDISC) AD therapeutic area data standard was a comprehensive collaborative effort by CDISC and Coalition Against Major Diseases, a consortium of the Critical Path Institute. Clinical concepts for AD and mild cognitive impairment were defined and a data standards user guide was created from various sources of input, including data dictionaries used in AD clinical trials and observational studies.ResultsA comprehensive collection of AD-specific clinical data standards consisting of clinical outcome measures, leading candidate genes, and cerebrospinal fluid and imaging biomarkers was developed. The AD version 2.0 (V2.0) Therapeutic Area User Guide was developed by diverse experts working with data scientists across multiple consortia through a comprehensive review and revision process. The AD CDISC standard is a publicly available resource to facilitate widespread use and implementation.DiscussionThe AD CDISC V2.0 data standard serves as a platform to catalyze reproducible research, data integration, and efficiencies in clinical trials. It allows for the mapping and integration of available data and provides a foundation for future studies, data sharing, and long-term registries in AD. The availability of consensus data standards for AD has the potential to facilitate clinical trial initiation and increase sharing and aggregation of data across observational studies and among clinical trials, thereby improving our understanding of disease progression and treatment.
Alzheimer's and Parkinson's diseases are the two main neurodegenerative disorders and despite the public health need, drug development for these conditions has been plagued by a high attrition rate in the late phases of evaluation. In order to improve the efficiency of the drug development process for these conditions, the Coalition Against Major Diseases was formed by the Critical Path Institute in September 2008, in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution (W ashington, DC, USA), with the aim of sharing precompetitive patient level data from legacy clinical t rials, and transforming those data into generalizable and shareable knowledge in the form of drug development tools for Alzheimer's and Parkinson's diseases. As of May 2011, Coalition Against Major Diseases has 21 members (14 pharmaceutical companies and seven patient groups), joined by the US FDA, the European Medicines Agency, the National Institute of Aging and the National Institute of Neurological Disorders and Stroke. The drug d evelopment tools in development will take the form of biomarkers and modeling and simulation frameworks, and will be submitted for regulatory evaluation and qualification as 'fit for purpose' in the specific context of the drug development process for these diseases. This article c onstitutes a report of the progress of the work of the coalition in data standards, disease models and biomarkers.
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