We use cookies to improve your experience. By continuing to browse this site, you accept our cookie policy.×
Skip main navigation
Aging Health
Bioelectronics in Medicine
Biomarkers in Medicine
Breast Cancer Management
CNS Oncology
Colorectal Cancer
Concussion
Epigenomics
Future Cardiology
Future Medicine AI
Future Microbiology
Future Neurology
Future Oncology
Future Rare Diseases
Future Virology
Hepatic Oncology
HIV Therapy
Immunotherapy
International Journal of Endocrine Oncology
International Journal of Hematologic Oncology
Journal of 3D Printing in Medicine
Lung Cancer Management
Melanoma Management
Nanomedicine
Neurodegenerative Disease Management
Pain Management
Pediatric Health
Personalized Medicine
Pharmacogenomics
Regenerative Medicine

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

    Amelia Wall Warner

    * Author for correspondence

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

    ,
    Karina L Bienfait

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

    ,
    Marianna Bledsoe

    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

    ,
    Gilbert Burckart

    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

    ,
    Bruno Flamion

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

    ,
    Bartha Knoppers

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

    ,
    Anita J Nelsen

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

    ,
    Allen Rudman

    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

    ,
    Nicole J Sieffert

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

    &
    Yoshiaki Uyama

    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

    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

    Published Online:https://doi.org/10.2217/pgs.12.193

    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.

    Papers of special note have been highlighted as: ▪ of interest

    References

    • Patterson SD, Cohen N, Karnoub M et al. Prospective retrospective biomarker analysis for regulatory consideration: a white paper from the Industry Pharmacogenomics Working Group (I-PWG). Pharmacogenomics12(7),939–951 (2011).▪ Perspective from the Industry Pharmacogenomics Working Group (I-PWG) regarding the utility of prospective-retrospective analysis of biomarkers.
    • Ricci DS, Broderick ED, Tchelet A et al. Global requirements for DNA sample collections: results of a survey of 204 ethics committees in 40 countries. Clin. Pharmacol. Ther.89(4),554–561 (2011).▪ Report of an institutional review boards/ethics committees survey conducted by the I-PWG related to the approval of pharmacogenetics studies, collection and banking of samples, and return of data to subjects.
    • Warner AW, Bhathena A, Gilardi S et al. Challenges in obtaining adequate genetic sample sets in clinical trials: the perspective of the Industry Pharmacogenomics Working Group. Clin. Pharmacol. Ther.89(4),529–536 (2011).▪ Report of a survey conducted by the I-PWG to assess pharmacogenetic sample collection practices in the pharmaceutical industry and to gather information on issues affecting collection.
    • Franc MA, Warner AW, Cohen N, Shaw PM, Groenen P, Snapir A. Current practices for DNA sample collection and storage in the pharmaceutical industry, and potential areas for harmonization: perspective of the I-PWG. Clin. Pharmacol. Ther.89(4),546–553 (2011).▪ Report of an I-PWG survey of pharmaceutical companies to determine current industry practices for collection and storage of pharmacogenomic samples.
    • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. J. Eur. Commun.L121,34–44 (2001).
    • Directive 1995/46/EC of the European Parliament and of the Council of 25 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. J. Eur. Commun.L281,31–39 (1995).
    • Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. J. Eur. Commun.L102,48–58 (2004).
    • Dal-Ré R, Luque I, Torres R, Lahuerta J. Drug development: assessment of pharmacogenetic studies by Spanish research ethics committees. Pharmacogenomics J.9,86–89 (2009).
    • Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. § 1320d-9 (2010).
    • 10  Department of Health and Human Services. Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Fed. Regist.76,44512–44531 (2011).
    • 101  Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Japan. Guidance: general principles for clinical trials using pharmacogenomics (2008). www.pmda.go.jp/operations/shonin/outline/shinrai/file/tuchi/1_0930007.pdf▪ Guidance from Japan’s Ministry of Health, Labour and Welfare outlining the general principles of pharmacogenomics in clinical trials and supporting the collection of future use samples for pharmacogenomic research.
    • 102  Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). 25 January 2012. http://ec.europa.eu/justice/data-protection/document/review2012/com_2012_11_en.pdf (Accessed 10 May 2012)▪ Draft privacy regulation from the European Council that when adopted by EU member states will affect the use of specimens for future research.
    • 103  Council of Europe, European Convention for the Protection of Human Rights and Fundamental Freedoms, 1 June 2010.www.echr.coe.int/NR/rdonlyres/D5CC24A7-DC13-4318-B457-5C9014916D7A/0/CONVENTION_ENG_WEB.pdf (Accessed 10 May 2012)
    • 104  US FDA. Clinical pharmacogenomics: premarketing evaluation in early phase clinical studies. February 2011. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243702.pdf (Accessed 10 May 2012)▪ Draft guidance document from the US FDA on pharmacogenomics in early phase clinical trials.
    • 105  ICH E15. Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories. April 2008.www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E15/Step4/E15_Guideline.pdf (Accessed 10 May 2012)