title: Development of a unified clinical trial database for Alzheimer's disease.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA.
authors: Jon
authors: J
authors: Neville
authors: CDISC, Austin, TX, USA.
authors: Steve
authors: S
authors: Kopko
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA.
authors: Steve
authors: S
authors: Broadbent
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA.
authors: Enrique
authors: E
authors: Avilés
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA.
authors: Robert
authors: R
authors: Stafford
authors: USC Department of Pharmaceutical Sciences, USA.
authors: Christine M
authors: CM
authors: Solinsky
authors: Independent Science Writer, Elverson, PA, USA.
authors: Lisa J
authors: LJ
authors: Bain
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA.
authors: Martin
authors: M
authors: Cisneroz
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA.
authors: Klaus
authors: K
authors: Romero
authors: Coalition Against Major Diseases (CAMD), Critical Path Institute, Tucson, AZ, USA. Electronic address: Dstephenson@c-path.org.
authors: Diane
authors: D
authors: Stephenson
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003071:Cognition; D016208:Databases, Factual; D003657:Decision Making; D006801:Humans; D020407:Internet; D012015:Reference Standards; D013223:Statistics as Topic
keywords: Alzheimer's disease; Clinical trials database; Data integration; Data standardization; Facilitated access; Placebo data