Originally published as JCO Early Release 10.1200/JCO.2007.15.6398 on April 7 2008

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American Society of Clinical Oncology Statement on Minimum Standards and Exemplary Attributes of Clinical Trial Sites

Robin Zon, Neal J. Meropol, Robert B. Catalano, Richard L. Schilsky

From Michiana Hematology Oncology, South Bend, IN; Fox Chase Cancer Center; Coalition of Cancer Cooperative Groups, Philadelphia, PA; and University of Chicago, Chicago, IL

Corresponding author: Neal J. Meropol, MD, Fox Chase Cancer Center, 333 Cottman Ave, Room C307, Philadelphia, PA 19111; e-mail: nj_meropol{at}fccc.edu

Purpose: To describe both minimum requirements for a site conducting quality clinical trials and attributes of an exemplary site.

Methods: Minimum requirements and exemplary attributes were selected based on literature review, prevailing regulatory requirements, and consensus among a group of community and academic clinical researchers.

Results: To provide guidance to oncologists who wish to conduct patient-oriented research, recommendations are made to assist in the development and implementation of high-quality research programs with the priority of protecting the welfare and rights of trial participants. A quality research site complies with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, the accepted international ethical and scientific quality standards for designing, conducting, recording, and reporting trials involving human participants. Recognizing that many research sites conduct clinical trials in compliance with accepted GCP standards, supplemental attributes of an exemplary research site that exceed the GCP criteria are also described. These attributes include diversification of clinical trial mix, high accrual activity, participation in the trial development process, maintenance of high educational standards, quality assurance, multidisciplinary involvement in the clinical trial process, and promotion of clinical trial awareness programs.

Conclusion: Meeting the minimum criteria ensures conduct of quality clinical trials; however, some sites may wish to incorporate value-added attributes to exceed GCP compliance. These attributes are proposed as performance goals rather than requirements, recognizing that all sites conducting research will not necessarily meet each attribute but may still conduct high-quality clinical trials.

published online ahead of print at www.jco.org on April 7, 2008.

Reviewed and approved by the American Society of Clinical Oncology Board of Directors, October 11, 2007.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.