title: Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011.
abstract: 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.
authors.affiliation: Merck & Co., Inc., Clinical Pharmacogenomics & Clinical Specimen Management, 351 North Sumneytown Pike, Upper Gwynedd, PA 19454, USA. amelia.warner@merck.com
authors.forename: Amelia Wall
authors.initials: AW
authors.lastname: Warner
authors.forename: Karina L
authors.initials: KL
authors.lastname: Bienfait
authors.forename: Marianna
authors.initials: M
authors.lastname: Bledsoe
authors.forename: Gilbert
authors.initials: G
authors.lastname: Burckart
authors.forename: Bruno
authors.initials: B
authors.lastname: Flamion
authors.forename: Bartha
authors.initials: B
authors.lastname: Knoppers
authors.forename: Anita J
authors.initials: AJ
authors.lastname: Nelsen
authors.forename: Allen
authors.initials: A
authors.lastname: Rudman
authors.forename: Nicole J
authors.initials: NJ
authors.lastname: Sieffert
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Uyama
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D055808:Drug Discovery / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods* / Q000592:standards