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

Autor: Diane Stephenson, Lisa J. Bain, Robert Stafford, Enrique Aviles, Steve Broadbent, Klaus Romero, Steve Kopko, Jon Neville, Christine M. Solinsky, Martin Cisneroz
Rok vydání: 2014
Předmět:
Zdroj: Alzheimer'sdementia : the journal of the Alzheimer's Association. 11(10)
ISSN: 1552-5279
Popis: 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.
Databáze: OpenAIRE