Achieving Exemplary Attributes With AccrualNet

Abstract

The AccrualNet Web site is a helpful compilation of resources for sites aspiring to improve trial accrual.

AccrualNet was developed by the National Cancer Institute (NCI) as an online resource to address challenges associated with accruing patients to cancer clinical trials.¹ The Web site uses several modalities to help research teams learn about evidence-based accrual methods, access tools and templates, educate staff, and network with colleagues.

This article, part of the Journal of Oncology Practice series on exemplary attributes of clinical trial sites, compliments an original research article published in this issue of JOP titled, AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform.² This article specifically highlights how AccrualNet can be used to achieve the seven attributes of exemplary clinical research sites, which were first published in the 2008 ASCO Statement on Minimum Standards and Exemplary Attributes of Clinical Trial Sites.³ Of note, this article is meant to provide a general overview of the Web site, specifically related to information regarding ASCO's exemplary attributes. The authors did not conduct a thorough analysis or formal evaluation of AccrualNet.

Diversification of the Clinical Trial Mix

As written in the ASCO Statement, exemplary clinical trial sites have diverse clinical trial portfolios that may include trials related to treatment, prevention, quality of life, and symptom management. When a new type of clinical trial is opened, AccrualNet can be used to identify evidence-based accrual methods specific to various trial types and to learn from colleagues about practices that have been successful at their site. Especially helpful are the AccrualNet resources related to “Selecting a Trial,” which advise evaluating a clinical trial portfolio, determining whether a research site will be able to complete all trial requirements, and evaluating whether accrual will be feasible on the basis of the site's patient population. The resources help the user answer the question, “Should this clinical trial be opened at my site?”¹

High Accrual Activity

The ASCO Statement encourages sites to set an accrual benchmark and conduct ongoing assessment of their accrual activity. Although all aspects of the AccrualNet Web site help research sites learn best practices for achieving high accrual activity, the section on “Managing the Trial” provides advice specific to monitoring accrual in a data-driven way. This includes resources for reviewing accrual according to expected performance, assessing what actual costs will be versus the budget, and monitoring for accrual of underserved populations. Also helpful is the “Conversations” tab, which enables users to connect with each other regarding topics related to trial accrual.

Participation in the Clinical Trial Development Process

Collaboration among all stakeholders is important in the clinical trials development process and is highlighted in the ASCO Statement. The AccrualNet page “Developing a Protocol” provides practical advice on how to develop clinical trial protocols that are most likely to accrue participants. This content is helpful for everyone from protocol authors to volunteers on trial sponsor boards and committees. Topics of interest include considering how the trial will be received at affiliate institutions, considering recruitment feasibility, choosing study sites, and developing patient-friendly materials. Particularly helpful are examples of protocol feasibility checklists that were developed by institutions throughout the country.

Maintenance of High Educational Standards

As noted in the ASCO Statement, “continuing education for investigators and research staff should be performed by exemplary sites.” AccrualNet helps sites achieve this attribute through a compilation of training resources listed under the tab titled “Training.” These resources are helpful for new members of the research team as well as seasoned members who wish to enhance their knowledge base. Some research sites have found AccrualNet resources to be especially helpful in educating fellows who may have access to limited formal training regarding the conduct of clinical research.² The Web page includes links to resources in a variety of formats (including online modules, videos, and manuals) that have been developed by the NCI and various other organizations.

Quality Assurance

Implementation of a quality assurance program is an attribute of exemplary research sites. The AccrualNet section on “Managing the Trial” offers articles and resources on monitoring accrual and taking action when a trial is not accruing well. In addition, the section on “Evaluating Accrual and Lessons Learned” provides advice on quality improvement activities to conduct after completion of a trial.

Multidisciplinary Involvement in the Clinical Trial Process

The ASCO Statement acknowledges the importance of physician and nonphysician involvement in the clinical trial process. AccrualNet provides resources to help sites makes this attribute a reality. Articles and resources in the section titled “Engage Intermediaries to Aid Accrual” relate to collaboration with referring physicians, patient advocates, patient navigators, and the overall community. Noteworthy resources include samples of PowerPoint presentations, an example of an internal newsletter on recruitment progress, and a guide for referring physicians.

Clinical Trial Awareness Programs

The ASCO Statement discusses the importance of awareness programs to educate lay populations and clinician colleagues about clinical trials. Resources available on AccrualNet can assist a research site wishing to develop, or enhance, its clinical trial awareness program. Select resources available in the section “Preparing to Open the Trial” include examples of advertisements, a guide for working with the media, and an accrual plan template. The section also links to a multitude of literature on topics such as developing a research culture and ensuring staff awareness about clinical trials.

Recommendations and Next Steps

One potential challenge the authors identified when using AccrualNet is difficulty navigating the Web site for specific resources. A resolution for this problem is to click on the tab “All Tools and Resources,” which facilitates searches using topics areas such as patient demographics, disease site, resource type, and trial type. Other search options include clicking the home page graphic that shows trial stages, and the free-text search field on every subpage.

Another feature the authors hope will be enhanced is the “Conversations” section, where users can post comments and share insights and resources. This section deserves continued focus because it has the potential to promote idea sharing and collaboration among multidisciplinary members of the research community. The authors applaud the AccrualNet Web site and encourage continued quality assessment to ensure the site remains well organized and easy to use.

Summary

The AccrualNet Web site is a helpful compilation of resources for sites aspiring to improve trial accrual. This article, part of the JOP series on attributes of exemplary clinical trial sites, highlights how the AccrualNet Web site can be used to inform efforts to achieve the exemplary attributes, as designated in the 2008 ASCO Statement.³ Research sites wishing to achieve the attributes may also want to explore resources offered by ASCO, including grant and award opportunities offered through the Conquer Cancer Foundation of ASCO,⁴ ASCO's Clinical Trial Resources Web page,⁵ and all of the articles in this JOP series on exemplary attributes of clinical trial sites.⁶ Also noteworthy are collaborative efforts between NCI and ASCO, including the NCI-ASCO Cancer Trial Accrual Symposium that was held in 2010.⁷ Conducting clinical research presents many challenges; however, the NCI and ASCO are committed to assisting research teams implement practices to increase participation in clinical trials and promote the conduct of high-quality cancer research.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

Author Contributions

Conception and design: Allison R. Baer, Robin Zon

Administrative support: Allison R. Baer

Data analysis and interpretation: Allison R. Baer, Jane Hajovsky, Robin Zon

Manuscript writing: All authors

Final approval of manuscript: All authors