Nasser, Nariman; Grady, Deborah MD, MPH; Balke, C. William MD
Ms. Nasser is director, Participant Recruitment Service, University of California, San Francisco (UCSF), Clinical and Translational Science Institute (CTSI), San Francisco, California.
Dr. Grady is professor, Department of Medicine, UCSF School of Medicine, and codirector, UCSF CTSI, San Francisco, California.
Dr. Balke is professor, Department of Medicine, UCSF School of Medicine, and director, Clinical Research Services Program, UCSF CTSI, San Francisco, California.
Editor's Note: This is a commentary on Kitterman DR, Cheng SK, Dilts DM, Orwoll ES. The prevalence and economic impact of low-enrolling clinical studies at an academic medical center. Acad Med. 2011;86:1360–1366.
Correspondence should be addressed to Dr. Balke, University of California, San Francisco, 505 Parnassus Avenue, M-1203, UCSF Box 0126, San Francisco, CA 94143-0126; telephone: (415) 476-8127; fax: (415) 514-8822; e-mail: email@example.com.
In this issue of Academic Medicine, Kitterman and colleagues report the results of an evaluation of the prevalence and cost of low-enrolling studies (zero or one participant enrolled) conducted at Oregon Health & Science University (OHSU). They found that one-third of all studies terminated between 2005 and 2009 at OHSU had low enrollment and that these low-enrolling studies cost the institution almost $1 million annually. The recruitment of research participants is critical to conducting clinical and translational research. Failure to recruit research participants has a negative financial impact, but, more importantly, underenrolled studies do not contribute to scientific or clinical knowledge. In this commentary, the authors describe four areas in which academic health centers (AHCs) could invest more effort and resources to improve the recruitment of research participants. First, more planning and resources should be put into determining the feasibility of participant recruitment. Second, studies that are underenrolling should be terminated early to prevent unethical research, to save financial and other resources, and to allow these resources to be applied to successful research. Third, AHCs should professionalize, centralize, and automate participant recruitment. Fourth, AHCs should take a leadership role in partnering with the public to improve participation in clinical research. Participant recruitment must be improved if clinical and translational research is to meet its promise of improving health.
The recruitment of research participants is critical to conducting clinical and translational research. If we cannot recruit adequately, we simply cannot carry out successful clinical research. In this issue of Academic Medicine, Kitterman and colleagues1 report the results of an evaluation of the prevalence and cost of low-enrolling studies (zero or one participant enrolled) at Oregon Health & Science University (OHSU). They found that one-third of all studies terminated between 2005 and 2009 at OHSU had low enrollment and that these low-enrolling studies cost the institution almost $1 million annually, using a conservative estimate. Failure to recruit research participants has a negative financial impact, but, more important, underenrolled studies are underpowered and often do not contribute to scientific or clinical knowledge. Such studies are unethical—at a minimum, they waste participant time and effort, and many put participants at risk without producing scientific or clinical benefit.
The problem of low enrollment is clearly not unique to OHSU. With some variation, similar dismal recruitment rates apply to all academic health centers (AHCs). Using the same strict definition of low enrollment as Kitterman and colleagues,1 Pierre2 reported in 2006 that 50% of independent inpatient and outpatient sites enrolled one or no patients into the studies initiated at these facilities. This supports the theory that the challenge of recruiting into clinical studies is neither new nor exclusive to AHCs. According to CenterWatch, more than 81% of clinical trials are delayed due to inadequate participant recruitment.3 Despite this serious and widespread problem, little attention has been given to developing innovative methods or implementing best practices for achieving successful participant recruitment.
Improving the Recruitment of Research Participants
We believe that there are at least four areas in which AHCs could invest more effort and resources to improve recruitment of research participants. First, while enormous effort is placed on developing clinical research protocols that are likely to have scientific and community health impact, very little planning and few resources are put into determining the feasibility of participant recruitment. Feasibility of recruitment depends on access to an adequate number of persons who fit the study inclusion criteria as well as on the willingness of these persons to enroll in the study. This willingness often depends on the attractiveness of the research question, the burden of study visits and measures, the invasiveness of study procedures, and the potential risks and benefits associated with the intervention. Much greater attention should be given to designing study protocols that maximize the ability to recruit participants, especially because nearly one-third of the entire cost of a study is invested in the recruitment phase.4 The feasibility of recruitment should also be a major criterion assessed during peer review.
Second, as suggested by Kitterman and colleagues,1 studies that are underenrolling should be terminated early to prevent unethical research, to save financial and other resources, and to allow these resources to be applied to successful research. Annual reports required by most institutional review boards (IRBs) collect data on enrollment, but, to our knowledge, underenrollment generally does not result in IRB requests for new plans to address this issue, and marked underenrollment does not result in the termination of a study. Because underenrollment is one of the main reasons that clinical research studies do not provide good scientific data and, thus, may be unethical, institutions and IRBs should pay more attention to this issue.
Third, AHCs need to professionalize, centralize, and automate the recruitment process. Most investigators still rely on study staff to recruit participants, staff who often have little experience in recruitment and no infrastructure to support their efforts. Professional, full-time, experienced participant recruiters should be available to help investigators optimize protocols for maximal recruitment, estimate resources needed for recruitment, develop recruitment plans and materials, and carry out these plans. Today, recruitment efforts across academic units are uncoordinated and do not take advantage of efficiencies of scale. Centralized recruitment services can improve efficiency and avoid overlap but, more important, can lead the development of key recruitment infrastructure, such as Web sites, call centers, databases, and well-coordinated recruitment campaigns that can sustain participant recruitment efforts across the AHC. Automated recruitment services might include searching clinical and patient databases for eligible participants, maintaining a participant-friendly, Web-based listing of studies actively enrolling at the AHC along with online prescreening tools, and developing a cadre of persons in the community interested in research who can be contacted using popular communications methods such as text messaging and social media.
Fourth, AHCs need to take a leadership role in partnering with the public to increase participation in clinical research. AHCs should play a major role in improving public education about clinical study design, safeguards, potential scientific and clinical impact, and the critical role of research participants. Finally, AHCs should work much more closely with patient advocacy groups to design and implement clinical research of importance to these groups.
How should we pay for professional, centralized, and automated participant recruitment services? We believe that this cost should be shared by the AHC and the study sponsor. As demonstrated by Kitterman and colleagues,1 reducing the number of studies that underenroll or are low enrollers can save an AHC a significant amount of wasted funds, suggesting that institutions should bear some of the cost of developing recruitment services. On the other hand, efficient, cost-effective, and successful recruitment is very valuable to all types of sponsors. A professional, centralized, and automated recruitment service should be supported by appropriately charging the study sponsor and will likely cost no more than current recruitment efforts.
Participant recruitment must be improved if clinical and translational research is to meet its promise of improving health. In this commentary, we offer several suggestions for attaining this goal, and we encourage others to join the conversation.
National Institutes of Health–National Center for Research Resources UCSF CTSI grant number UL1 RR024131.
The contents of this commentary are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
1 Kitterman DR, Cheng SK, Dilts DM, Orwoll ES. The prevalence and economic impact of low-enrolling clinical studies at an academic medical center. Acad Med. 2011;86:1360–1366.
2 Pierre C. Recruitment and retention in clinical trials: What works, what doesn't and why. Paper presented at: 2006 Drug Information Association Annual Summit; June 2006; Philadelphia, Pa.
3 CenterWatch. An industry in evolution: A sourcebook of charts and statistics. Boston, Mass; Thomson CenterWatch; 2006.
4 Getz K. The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial. Bar Harbor, Me: Jerian Publishing; 2007.