[The significance of biobanks for clinical development]. / Die Bedeutung von Biobanken für die klinische Entwicklung.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
; 59(3): 344-50, 2016 Mar.
Article
em De
| MEDLINE
| ID: mdl-26847235
ABSTRACT
Access to samples in biobanks and collection of samples for evaluation of biomarkers in clinical trials are an essential basis for the identification and development of biomarkers. From the perspective of a research-based pharmaceutical company identification of biomarkers and the accompanying diagnostics are an essential prerequisite for the further evolution of personalised healthcare-and the key to more effective and efficient healthcare. Research-based pharmaceutical companies can basically use four types of biobanks biobanks of university hospitals, commercial providers, collaborative groups and company-owned biobanks. Areas of application, arising from the use of biobanks in the context of clinical development, are collection of prevalence data, evaluation of biomarker stability in different disease stages, technical validation of assays, an optimized course of clinical studies by focusing on defined, biomarker-stratified groups of patients and pharmacogenetic research. Challenges are, in particular, the availability of clinically annotated samples and tissue matching blood samples, in addition to sample quality, number and amount. An acceptable legal and regulatory framework, as well as the positive perception of biomarker data by politicians and the public, are important prerequisites for translational research for identification of biomarkers in clinical studies. Also, the early establishment of research alliances between academia and the pharmaceutical industry are required to transfer research results in new strategies for prevention, diagnosis and treatment of patients.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Obtenção de Tecidos e Órgãos
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Modelos Organizacionais
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Bancos de Espécimes Biológicos
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Pesquisa Biomédica
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Indústria Farmacêutica
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Pesquisa Translacional Biomédica
Tipo de estudo:
Risk_factors_studies
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
De
Revista:
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
Assunto da revista:
SAUDE PUBLICA
Ano de publicação:
2016
Tipo de documento:
Article