Therapeutic Area Data Standards for Autosomal Dominant Polycystic Kidney Disease: A Report From the Polycystic Kidney Disease Outcomes Consortium (PKDOC).
Am J Kidney Dis
; 66(4): 583-90, 2015 Oct.
Article
em En
| MEDLINE
| ID: mdl-26088508
ABSTRACT
Data standards provide a structure for consistent understanding and exchange of data and enable the integration of data across studies for integrated analysis. There is no data standard applicable to kidney disease. We describe the process for development of the first-ever Clinical Data Interchange Standards Consortium (CDISC) data standard for autosomal dominant polycystic kidney disease (ADPKD) by the Polycystic Kidney Disease Outcomes Consortium (PKDOC). Definition of common data elements and creation of ADPKD-specific data standards from case report forms used in long-term ADPKD registries, an observational cohort (Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease [CRISP] 1 and 2), and a randomized clinical trial (Halt Progression of Polycystic Kidney Disease [HALT-PKD]) are described in detail. This data standard underwent extensive review, including a global public comment period, and is now available online as the first PKD-specific data standard (www.cdisc.org/therapeutic). Submission of clinical trial data that use standard data structures and terminology will be required for new electronic submissions to the US Food and Drug Administration for all disease areas by the end of 2016. This data standard will allow for the mapping and pooling of available data into a common data set in addition to providing a foundation for future studies, data sharing, and long-term registries in ADPKD. This data set will also be used to support the regulatory qualification of total kidney volume as a prognostic biomarker for use in clinical trials. The availability of consensus data standards for ADPKD has the potential to facilitate clinical trial initiation and increase sharing and aggregation of data across observational studies and among completed clinical trials, thereby improving our understanding of disease progression and treatment.
Palavras-chave
Autosomal dominant polycystic kidney disease (ADPKD); Clinical Data Interchange Standards Consortium (CDISC); Polycystic Kidney Disease Outcomes Consortium (PKDOC); consensus data standards; controlled terminology; data pooling; disease progression biomarker; standard data structure; total kidney volume (TKV)
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Bases de Dados Factuais
/
Rim Policístico Autossômico Dominante
/
Guias de Prática Clínica como Assunto
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Guideline
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Observational_studies
/
Prognostic_studies
Limite:
Female
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Humans
/
Male
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article