Improving clinical trial sampling for future research – an international approach: outcomes and next steps from the DIA future use sampling workshop 2011

Author:

Warner Amelia Wall1,Bienfait Karina L2,Bledsoe Marianna3,Burckart Gilbert4,Flamion Bruno5,Knoppers Bartha6,Nelsen Anita J7,Rudman Allen4,Sieffert Nicole J8,Uyama Yoshiaki910

Affiliation:

1. Merck & Co., Inc., Clinical Pharmacogenomics & Clinical Specimen Management, 351 North Sumneytown Pike, UGD4-34, Upper Gwynedd, PA 19454, USA.

2. Merck & Co., Inc., Clinical Pharmacogenomics & Clinical Specimen Management, 351 North Sumneytown Pike, UGD4-34, Upper Gwynedd, PA 19454, USA

3. Biorepository & Tissue Banking, Biomedical Laboratory R&D Service, Office of Research & Development, Department of Veterans Affairs, 810 Vermont Ave NW (10P9B), Washington, DC 20420, USA

4. Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, White Oak Building 51, Room 3184, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, USA

5. Physiology & Pharmacology Unit, University of Namur, Belgium, 61 rue de Bruxelles, 5000 Namur, Belgium

6. Faculty of Medicine, Department of Human Genetics, McGill University, 740 Dr Penfield Avenue, Room 5214, Montreal, QC, H3A 0G1, Canada

7. GlaxoSmithKline, Genetics, 5 Moore Drive, Research Triangle Park, NC 27709, USA

8. MD Anderson Cancer Center, 1400 Pressler Street, Unit 1435, Houston, TX 77030, USA

9. Regulatory Science Research Division, Office of Regulatory Science, Pharmaceuticals & Medical Devices Agency (PMDA), Shin-Kasumigaski Building, 3-3-2 Kasumigaseki, Chioyodaku, Tokyo 100-0013, Japan

10. Department of Regulatory Science & Public Administration of Medicine, Graduate School of Medical & Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan

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.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Genetics,Molecular Medicine

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