title: Challenges in obtaining adequate genetic sample sets in clinical trials: the perspective of the industry pharmacogenomics working group.
abstract: Collection of DNA samples from subjects participating in clinical trials is vital to understanding variability in drug response. The purpose of this study was to assess pharmacogenetic sample-collection practices in the industry and to gather information on issues affecting collection. A survey questionnaire was developed and distributed to 20 pharmaceutical companies; 15 provided responses. Assessments included rate of DNA sample collection, reasons for low collection rates, reasons for rejection by health authorities (HAs) and institutional review boards/ethics committees (IRBs/ECs), and country-specific hurdles to sample collection. The results indicated that, although DNA samples are frequently collected, sample-acquisition rates remain lower than expected. Overall, the companies' experience has been that restrictions on sample usage are not consistently applied by regulatory bodies. This may reflect changing opinions/interpretations of HAs/IRBs/ECs. Collection of DNA samples in industry trials is still a challenge. Harmonization of sample-collection practices may facilitate the process.
authors.affiliation: Clinical Pharmacogenomics and Clinical Specimen Management, Merck & Co., Inc., North Wales, Pennsylvania, USA. amelia.warner@merck.com
authors.forename: A W
authors.initials: AW
authors.lastname: Warner
authors.forename: A
authors.initials: A
authors.lastname: Bhathena
authors.forename: S
authors.initials: S
authors.lastname: Gilardi
authors.forename: D
authors.initials: D
authors.lastname: Mohr
authors.forename: D
authors.initials: D
authors.lastname: Leong
authors.forename: K L
authors.initials: KL
authors.lastname: Bienfait
authors.forename: J
authors.initials: J
authors.lastname: Sarang
authors.forename: S
authors.initials: S
authors.lastname: Duprey
authors.forename: M A
authors.initials: MA
authors.lastname: Franc
authors.forename: A
authors.initials: A
authors.lastname: Nelsen
authors.forename: A
authors.initials: A
authors.lastname: Snapir
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D004247:DNA / Q000032:analysis*; D003625:Data Collection; D004345:Drug Industry / Q000706:statistics & numerical data*; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods*; D013048:Specimen Handling / Q000379:methods
chemical_list: D004247:DNA