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Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011.
Warner, Amelia Wall; Bienfait, Karina L; Bledsoe, Marianna; Burckart, Gilbert; Flamion, Bruno; Knoppers, Bartha; Nelsen, Anita J; Rudman, Allen; Sieffert, Nicole J; Uyama, Yoshiaki.
Afiliação
  • Warner AW; Merck & Co., Inc., Clinical Pharmacogenomics & Clinical Specimen Management, 351 North Sumneytown Pike, Upper Gwynedd, PA 19454, USA. amelia.warner@merck.com
Pharmacogenomics ; 14(1): 103-12, 2013 Jan.
Article em En | MEDLINE | ID: mdl-23252952
Clinical trial samples collected for pharmacogenomic and future research are vital resources for the development of safe and effective drugs, yet collecting adequate, representative sample sets in global trials is challenging. The Drug Information Association (DIA) sponsored a workshop on future use sampling in September 2011, bringing together experts from regulatory agencies, academia and industry to discuss challenges to future use sample collection and identify actions to improve collection. Several common themes and associated action items emerged, including the need for international guidance on the collection of samples for future research; additional discussion related to coding, scope of research, and return of research results; and additional education about pharmacogenomic/future research and the importance of long-term storage of specimens.
Assuntos

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Farmacogenética / Ensaios Clínicos como Assunto / Indústria Farmacêutica / Descoberta de Drogas Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Revista: Pharmacogenomics Assunto da revista: FARMACOLOGIA / GENETICA MEDICA Ano de publicação: 2013 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Farmacogenética / Ensaios Clínicos como Assunto / Indústria Farmacêutica / Descoberta de Drogas Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Revista: Pharmacogenomics Assunto da revista: FARMACOLOGIA / GENETICA MEDICA Ano de publicação: 2013 Tipo de documento: Article País de afiliação: Estados Unidos