Factors Affecting Patient Enrollment in Radiology Clinical Trials: A Case Study of the American College of Radiology Imaging Network

doi:10.1016/S1076-6332(03)80365-3

Academic Radiology

Volume 9, Issue 7, July 2002, Pages 862-869

https://doi.org/10.1016/S1076-6332(03)80365-3 Get rights and content

Abstract

Rationale and Objectives

This study was designed to identify factors that affect the enrollment of patients into American College of Radiology Imaging Network clinical trials.

Materials and Methods

A quality improvement study was performed. Brainstorming produced an exhaustive list of factors that could affect the interest of sites in participating in American College of Radiology Imaging Network trials, as well as factors that could influence patient recruitment. Surveys, structured interviews, and benchmarking were used to validate and rank the importance of these factors.

Results

Site participation was influenced mainly by the support of the department chair and the interest of the investigator. Patient recruitment was affected primarily by the ease of identifying candidates and the perceived experience level and skill of the support staff.

Conclusion

Because radiologists do not control patient referrals for imaging tests, a premium must be placed on developing systems to maximize the identification and enrollment of candidates for clinical trials. Other factors considered critical to success in patient enrollment include the supportiveness of the departmental leadership, the experience and skill level of study personnel, and the availability of site-specific infrastructure to support the study.

Section snippets

Study Design

The approach to this study was to execute a quality improvement project. In particular, we analyzed ACRIN's structure and processes with an eye toward understanding how these systems facilitate or impede the ability of ACRIN to accomplish its main performance goal: the efficient development, execution, and completion of important clinical trials. From such analyses, one can derive recommendations for process improvement (1, 2, 3).

General Methods

Four main techniques were used in this project: brainstorming,

Task 1: Factors Affecting Patient Identification and Enrollment

The 15 hypothesized factors affecting patient enrollment could be grouped for simplicity into four major categories: ease of identifying eligible patients, effectiveness of the enrollment process, experience and skill of study personnel, and level of motivation of study personnel.

The mean ratings given to each of these categories are presented in Table 1. The respondents generally believed that the experience and skill of study personnel was the most important factor affecting enrollment and

Discussion and Recommendations

From the data collected and observations made, it seems clear that ACRIN's performance can be improved through adjustments in its structure and processes. What follows is a discussion of what the Advisory Panel believes are the two fundamental problems in structure and process, along with a set of suggested rational interventions for each of them.

Acknowledgments

The authors thank Mary-Beth Muckian and Betty Emanuel for their assistance in manuscript preparation.

References (4)

DM Berwick
Continuous improvement as an ideal in health care
N Engl J Med
(1989)

There are more references available in the full text version of this article.

Cited by (4)

The research associate committee of the ACR imaging network
2006, Journal of the American College of Radiology
Research associates (RAs) play an important role in ensuring the quality of clinical trials. They are largely responsible for maintaining the accuracy and timeliness of data collected and for complying with applicable regulations. At the ACR Imaging Network (ACRIN), a cooperative group, RAs have formed a committee with the mission of helping ACRIN achieve its goal of conducting quality multi-institutional imaging clinical trials. Because of the varying backgrounds and levels of experience of ACRIN’s RAs, one of the first goals of the committee was to develop an educational program that would provide standard training to all RAs. The committee also felt that RAs should be involved in the protocol development process from the earliest stages, and they are now represented on each major ACRIN committee. Other committee activities include publishing a newsletter, conducting an RA questionnaire, maintaining a Web page, and developing an online training tool. With hard work from the committee members, support from ACRIN’s leadership, and demonstrated accomplishments, the committee has become an integral part of ACRIN’s organization.
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