Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites — JOP

* Copyright © 2010 by American Society of Clinical Oncology

Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites

1. Allison R. Baer, RN, BSN,
2. Gary Cohen, MD,
3. Dee Anna Smith and
4. Robin Zon, MD, FACP

+ Author Affiliations

1. American Society of Clinical Oncology, Alexandria, VA; Berman Cancer Institute, Greater Baltimore Medical Center, Baltimore, MD; Sarah Cannon Research Institute, Nashville, TN; Michiana Hematology Oncology, South Bend, IN

1. Corresponding author: Allison Baer, RN, BSN, Clinical Trials Specialist, Department of Research Policy, American Society of Clinical Oncology, 2318 Mill Rd, Ste 800, Alexandria, VA 22314; e-mail: Allison.Baer@asco.org.



Introduction

Conducting clinical research is an integral part of cancer care and treatment advances. In 2008, ASCO published the Statement on Minimum Standards and Attributes of Exemplary Clinical Trial Sites to address the minimum requirements of sites conducting quality clinical trials and the attributes of exemplary sites.1 Both the minimum requirements and exemplary attributes were based on a review of the literature, current regulatory requirements, and consensus among community and academic clinical researchers. After publication of the Statement, ASCO developed several initiatives to assist research sites in developing and maintaining exemplary research programs. These initiatives include award and grant opportunities through the ASCO Cancer Foundation,2 the Exemplary Attributes article series published in Journal of Oncology Practice (JOP)3 and development of a Web page (www.asco.org/ClinicalTrialResources) that links to helpful clinical trial resources.

Most recently, at the 2010 ASCO Annual Meeting, members from the Exemplary Attributes Working Group presented an extended education session on the implementation of clinical trials. The session can now be viewed online through ASCO Virtual Meeting and is entitled, “Implementing Clinical Trials: Risks, Benefits, Marketing and Paying for It All.”4 On the basis of the positive feedback from this session, the faculty has chosen to review some of the session's content in a two-part series of articles. Although numerous topics were covered in the session, these two articles will specifically focus on the seven attributes of exemplary clinical trial sites, as stated in the ASCO Statement: (1) diversification of the clinical trial mix, (2) high accrual activity, (3) participation in the clinical trial development process, (4) maintenance of high educational standards, (5) quality assurance, (6) multidisciplinary involvement in the clinical trial process, and (7) clinical trial awareness programs.

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Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites — JOP