Challenges and Facilitators of Community Clinical Oncology Program Participation: A Qualitative Study/PRACTITIONER APPLICATION [Journal of Healthcare Management]

(Journal of Healthcare Management Via Acquire Media NewsEdge) Ann Scheck McAleamey, ScD, professor and vice chair for research, Department of Family Medicine, College of Medicine, The Ohio State University, Columbus; Kristin L. Reiter, PhD, assistant professor, Department of Health Policy and Management, University of North Carolina at Chapel Hill; Bryan J. Weiner, PhD, professor, Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill; Lori Minasian, MD, chief, Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland; and Paula H. Song, PhD, assistant professor, Division of Health Services Management and Policy, College of Public Health, The Ohio State University EXECUTIVE SUMMARY Successful participation in the National Cancer Institute's Community Clinical Oncology Program (CCOP) can expand access to clinical trials and promote cancer treatment innovations for patients and communities without access to major cancer centers. Yet CCOP participation involves administrative, financial, and organizational challenges that can affect hospital and provider participants. This study was designed to improve our understanding of challenges associated with CCOP participation from the perspectives of involved providers and to learn about opportunities to overcome these challenges.

We conducted five case studies of hospitals and providers engaged with the CCOP. Across organizations, we interviewed 41 key administrative, physician, and nurse informants. We asked about CCOP participation, focusing on issues related to implementation, operations, and organizational support.

Challenges associated with CCOP participation included lack of appreciation for the value of participation and poor understanding about CCOP operations, cost, and required workflow changes, among others. Informants also suggested opportunities to facilitate participation: (1) increase awareness of the CCOP, (2) enhance commitment to the CCOP, and (3) promote and support champions of the CCOP.

Improving our understanding of the challenges and facilitators of CCOP participation may assist hospitals and providers in increasing and sustaining participation in the CCOP, thus helping to preserve access to innovative cancer treatment options for patients in need.

For more information on the concepts in this article, please contact Dr. McAlearney at mcalearney.l@osu.edu.

BACKGROUND As the potential increases for scientific advances to improve the delivery of cancer care, health services providers are challenged to translate research findings into practice. The National Institutes of Health's (NIH) Roadmap initiative was established to facilitate this translation process (Zerhouni, 2003; NIH, 2011), including supporting the development of provider-based research networks (PBRNs) that can promote the extension of clinical trials research into community practice settings (Mold & Peterson, 2005; Westfall, Mold, & Fagnan, 2007; Ryan et al., 2011).

The Community Clinical Oncology Program (CCOP) of the National Cancer Institute (NCI) is an example of a PBRN - a collaborative partnership between research institutions and community-based physicians and medical groups - that has shown early promise in accelerating cancer treatment progress (Lanier, 2008; NCI, 2011a; Minasian et al., 2010). The NCI CCOP was initiated in 1983 specifically to facilitate Phase III clinical trials involving cancer prevention, treatment, and control in community-based practice settings. By 2010, the NCI's total budget for the CCOP was $93.6 million and provided support for 47 CCOP organizations nationwide. Currently, 340 hospitals and 2,900 community physicians (e.g., oncologists, surgeons) are represented in the NCI CCOP (NCI, 2011b).

The CCOP is designed to disseminate and implement advances in cancer care through support of a research infrastructure linking cancer investigators and academic centers to communitybased settings where the majority of patients receive their care (Minasian et al., 2010; NCI, 2011a). Successful CCOP organizations thus expand access to clinical trials and promote cancer treatment innovations within patient populations and communities that might not otherwise have such access (Minasian et al., 2010; Sales, Smith, Curran, & Kochevar, 2006).

In practice, individual CCOP organizations apply for and receive research grant funding through an NCI-led peer review process. Awards are granted depending on patient recruitment to clinical trials and research productivity; these awards do not typically cover all costs associated with maintaining the clinical trials research infrastructure (Minasian et al., 2010; Reiter et al., 2012). As a result, CCOP participation involves issues of organization, cost, and planning that may be of concern to both hospital and provider participants. In addition, concerns such as building relationships with physicians, monitoring data collection, and recruiting qualified staff have been specifically noted (Lamb, Greenlick, & McCarty, 1998; McKinney, Weiner, & Wang, 2006; Weiner, McKinney, & Carpenter, 2006). Unfavorable economic climates can thus create pressures for providers attempting to sustain CCOP participation (Carpenter, Weiner, Kaluzny, Domino, & Lee, 2006; McKinney, Weiner, & Carpenter, 2006; Sung et al., 2003).

Although prior studies have examined these issues from the perspectives of policy makers and clinical scientists, we know very little about the challenges faced by the hospitals and clinicians who participate in the CCOP and even less about facilitators of participation. Further, for those hospitals interested in CCOP participation, little information is available to inform their planning and decision-making processes regarding the CCOP.

As part of a larger study examining the business case for CCOP participation, we undertook the additional analyses reported in this article to improve our understanding of the challenges hospitals and clinicians associate with CCOP participation. We were also interested in learning about opportunities to overcome participation challenges that could provide insight to hospitals and other provider organizations struggling to sustain CCOP involvement.

METHODS We designed a case-based qualitative study (Yin, 2008) to examine hospitals' and clinicians' perspectives about the business case for CCOP participation, including considerations of the financial and nonfinancial benefits associated with participation (Song, Reiter, Weiner, Minasian, & McAlearney, in press). From this larger study, interviewees' comments frequently included perspectives about the overall challenges and facilitators of CCOP participation. We undertook secondary analyses of this extensive qualitative data set to learn more about these participation challenges from the perspectives of the multiple key informants we interviewed, as we describe in the next sections.

Study Setting and Sample We purposively selected CCOP organizations for our study to ensure that our sample varied with respect to CCOP organization size, structure, geographic region, and maturity (i.e., length of time operating as a CCOP). We were interested in these dimensions in order to learn about CCOP participation from the perspectives of different types of CCOP organizations and from interviewees who had differing lengths of experience with the NCl CCOP.

Our final study sample included four established CCOP provider organizations-two of which had been in operation for more than 10 years and two of which had been in operation for fewer than 10 years - and one that had recently applied to become a CCOP organization but had not yet been selected. By interviewing multiple key informants across these five organizations, we ensured that we reached saturation with respect to interviewees' responses to the questions we asked.

Data Collection We conducted 41 key informant interviews via telephone between August 2008 and April 2010 across the five sites. For each site, we identified a key contact person associated with the CCOP (e.g., the CCOP administrator, the CCOP principal investigator) and asked that individual to identify additional informants appropriate for our study. We sought to interview both administrators and clinicians associated with the CCOP provider organizations, including community-based physicians who had been involved in CCOP clinical trials research.

Key informants included administrative representatives (n = 22) (e.g., administrators and staff members involved in CCOP operations), physicians (n = 13), and nurses (n = 6). We present additional detail about our key informants by site and informant type in Table 1. Informed consent was obtained from all interviewees.

We used a standardized guide to facilitate the interview process, with one version tailored for administrative informants and another tailored for clinical informants. The interview guides included both semistructured questions and probes designed to permit deeper exploration of informants' responses. Questions about CCOP participation were asked directly of all informants and included the following five general domains: (1) history and background, (2) CCOP participation, (3) direct financial costs and benefits of CCOP participation, (4) nonfinancial (i.e., incidental) costs and benefits of CCOP participation, and (5) return on investment. Questions in Domain 3 (e.g., "What are the direct costs associated with CCOP participation " "Are there additional costs as well ") and Domain 4 (e.g., "Are there non-financial costs associated with CCOP participation " "Have you experienced any difficulty hiring or retaining qualified research staff ") often stimulated responses that involved interviewees discussing the challenges of CCOP participation.

As the study progressed, we continually reviewed our interview notes. In cases where respondents' answers prompted new question probes during a given interview, we used that opportunity to enhance our interview guides for future interviews. For instance, our open-ended approach to concluding our interviews led several interviewees to speculate about what could help their organizations with respect to CCOP participation; we then decided to formally include a question about facilitators of CCOP participation in future interviews.

Key informant interviews lasted 30-60 minutes, with the majority conducted by at least two interviewers. Each interview was recorded and transcribed verbatim, and transcripts were verified and corrected to permit further analyses.

Analyses We analyzed interview data using a combination of deductive and inductive methods (Miles & Huberman, 1994; Strauss & Corbin, 1998). Using a grounded theory approach (Strauss & Corbin, 1998; Glaser & Strauss, 1967), we reviewed interview notes and transcripts and held discussions about preliminary findings as the interviews progressed. These discussions enabled us to identify themes emerging from our interviews and prompted the development of formal question probes to include in subsequent interviews, as discussed above. At the conclusion of our interviews we formed an analysis team composed of the lead qualitative investigator and two research assistants to code all of the transcripts.

For our inductive analysis, we developed a codebook by which to denote responses to all of the direct questions that key informants had been asked. The coding team used this codebook individually to code three common transcripts then met to reach agreement about code definitions and use. Our analyses were supported by use of the Atlas.ti qualitative data analysis software (Scientific Software Development, 2009).

Our deductive analysis was based on our iterative review of codes and transcripts, which occurred as the coding progressed. Throughout this process, the coding team met periodically to ensure coding consistency and to discuss the emergence of themes and subthemes individual coders found in the data. As a group we defined themes and subthemes when we found confirmation across at least three case sites, and we reached agreement about their characterizations among the members of the analysis team. We discuss our findings about these themes and subthemes next.

RESULTS Challenges of CCOP Participation We categorized interviewees' comments related to the challenges of CCOP participation into seven topics reported as important across the five study sites. Following we present each challenge, and in Table 2 we provide select verbatim responses from our informants to further characterize these challenges.

Appreciating the Value of a CCOP Both administrative and clinical interviewees across sites noted how the lack of appreciation by senior leadership for the value of a CCOP created a major challenge for CCOP participation. As one CCOP physician principal investigator (PI) noted, "I don't think they [senior management] understand how cutting edge in terms of the research is that can be done through a CCOP." Even at the site applying for a CCOP grant, an interviewee explained, "I'm not so sure, to be honest, if the senior leadership really understands what a CCOP is or how important it might be to a cancer program." This lack of understanding and appreciation was of particular note when informants expressed concern about the needs to continually justify CCOP participation and sustain CCOP involvement.

Understanding CCOP Operations Interviewees across sites made a number of comments about the challenges associated with understanding and managing CCOP operations. This issue was raised with respect to both the initial decision to engage with the CCOP and the requirements associated with managing CCOP participation over time. As one interviewee commented, "We were all busy, you know, flying through meetings, looking through the latest protocol [i.e., procedures associated with a clinical trial], but not talking about how do we do the nuts and bolts of our business." Another said, "The one thing that floored me when I walked into this was, do you understand that if you don't have a good business manager you won't go anywhere This is not something that should be left to chance. You really need a professional to understand how you navigate the structure of the NCI and how you run a business." The need for specific understanding of CCOP operations was especially salient in the context of threatened budgets associated with maintaining CCOP involvement.

Affording CCOP Participation One physician reflecting on the challenge of affording the costs associated with CCOP participation commented, "[Ojbviously, the financial burden [is] on the practices. . . . You find out that doing all this costs you money. It's a lot of burden on you, and then you start wondering, why am I doing this " Similarly, a CCOP administrator explained, "you're working at a loss business here. You've got to sell that. You've got to find ways to support it, and you have to . . . keep that moving forward. And I don't know too many loss businesses that actually survive." Respondents were generally aware that the CCOP organization received some support from the NCI, but their comments about cost as a challenge to CCOP participation were common across respondent types and indicated a level of insecurity about sustaining CCOP participation over time.

Dealing with CCOP Requirements Meeting CCOP participation requirements presented particular roadblocks across sites. As one administrator noted, "I think they [the NCI] present a lot of challenges in the program that they dump on the CCOPs themselves to solve. They say, This is what we want you to do . . . but sorry that there aren't any protocols for you.' " Another administrator explained, "CCOPs have their own level of responsibilities, requirements, very grant-specific things that don't always mesh with what the strategic plan is for the hospitals. And sometimes that's difficult to work together." These requirements raised concerns about the viability of maintaining CCOP participation when the burden of meeting CCOP requirements did not seem to match the perceived benefits of participation.

Changing Workflow to Accommodate the CCOP Informants explicitly discussed the need to make changes in employee training, data collection processes, and general operations to support participation. One nurse commented about "the sheer number of patients that we see in the clinic, and the number of satellite offices that we've had opened. So each one of those requires training, and bringing on new nurses, and improving our quality as far as the orientation process." Another described how the CCOP involved additional employee stress: "[Y]ou really realize that we all are very stressed with caring for a population that may or may not survive. And riding that rollercoaster with them and helping them navigate is really a huge part of why we're successful. . . . Supporting the people I work with is huge." Additional comments described challenges around laboratory, pharmacy, finance, and institutional review board process changes, all areas that were of concern when informants were discussing both initiating and sustaining CCOP participation.

Managing Patient Recruitment and Physician Involvement Comments were made related to managing the recruitment of sufficient numbers of patients to maintain multiple trials and ensuring physician participation in the trials that had been opened. As one informant said, "We have quite a few people [physicians] who are, quote, 'on the list.' And then there's the people who are really, really active. These are the people that are . . . the bedrock team/ if you will, that's always front and center. . . . [B]ut there are physicians who don't really participate at all." Balancing trial recruitment needs with varying levels of physician involvement and engagement appeared to challenge all CCOP study sites, indicating another area of concern about sustaining CCOP participation.

Sustaining Administrative Support The issue of sustaining administrative support for the CCOP over time was salient with respect to ongoing operations and organizational decisions to reapply for a CCOP grant. As one CCOP manager noted, "I think some of the upper-level high-liners [executives] would vote that we just don't need this here anymore; it's hurting the hospital's bottom line, [so] let's just do away with it. [A]nd I've heard other CCOPs around the country having some of those issues, having to go to battle to maintain themselves." Physicians expressed similar concerns. One explained, "[T]hey just say they support it, but then when it comes time to say how much they're going to support it, there's always something else that is more important. So the research budget gets hacked every year. " Comments from all types of informants across each CCOP site suggested that the need to engage and sustain support over time was a particular challenge they associated with CCOP participation.

Key Factors Facilitating CCOP Participation We categorized interviewees' comments about what could help support, or facilitate, CCOP participation into three main themes: awareness, commitment, and someone to serve as champion. These themes appeared prominent across informant types and study sites (i.e., they were consistently mentioned across at least three sites) and represented perspectives about the factors related to becoming a CCOP and maintaining CCOP participation. Further explanation of these facilitators and the subthemes associated with each main theme are provided next, with additional evidence from respondents' verbatim quotations presented in Table 3.

Awareness The opportunity to increase awareness of the CCOP toward facilitating participation was repeatedly noted across sites. This theme was characterized by two related subthemes: building awareness and understanding of the importance of the CCOP across the organization, and keeping doctors and patients informed about clinical trials.

As to building awareness and understanding, one CCOP manager explained, "I think some of our upper-level vice presidents support that and understand it and get why we're here and see the value of us." At another site, an interviewee commented, "We have gotten the message from them [hospital leadership] that they understand who we are, what we're doing, and how important we are, and they support us in that role. They allow our administrator to do what we need to do to keep that going." The second subtheme, the importance of keeping physicians and patients informed about CCOP trials, was demonstrated by one site's administrator, who explained, "The clinical staff here have really done a good job of keeping all principal investigators informed of new trials. They have these cards [that describe which patients would be eligible for the trials] that they make for each of the physicians to put in their pockets; [the cards are) very widely used. And every trial that's opened [has a card made]. And it's [the cards are] updated very, very frequently." This subtheme was also apparent in informants' comments about how they needed to inform new clinicians about the CCOP. For instance, one administrator explained how the organization would "bring on new doctors that are new to this research program and get them comfortable and referring to the protocols and aware of the protocols, and understanding how our intake system works." Other related comments described explicit organizational communication efforts.

Commitment Commitment was distinguished by role as either a member of hospital administration or a clinician. Commitment from hospital administrators as a facilitator was mentioned at every site. As one interviewee described, "I think [the hospital's leaders are] very committed, and that's the piece of why we're still in existence." Another noted, "We had buy-in from senior leadership in terms of the CEO knew what I was doing and wanted it to be successful." Administrative commitment was characterized by descriptors such as support, responsibility, and financial commitment.

Commitment from clinicians was noted as a key facilitator because of clinicians' importance to the trials. As one administrator described, "They're our principal investigators. They're the ones who allow us to function through their offices and also have been instrumental in linking us over the 20-plus years to the local hospitals as well." Another hospital's research nurse reflected on the importance of this commitment over time. "I think as the years have gone by, the physicians are more and more committed to the CCOP. I think that is recognized, or I've recognized that, just through the increased number of physicians doing clinical trials with our CCOP." The involvement of nurse clinicians as a facilitator of CCOP participation was seen in several quotes, examples of which are presented in Table 3.

Champions Across sites, the influence of administrative champions was frequently discussed. One interviewee described the organization's CCOP director as having "definitely been a champion. . . . She goes to bat for us, be it with the economy being so poor, she [works] for us to make sure we all keep our jobs and our funding and keeping operational costs down." At another site, an administrative champion was similarly lauded: "She's been a strong supporter, and then she also helps to spread the support among the staff, whether it's medical assistants or nurses in medical oncology here, who are very instrumental in helping to identify patients as appropriate [for participation in the trial], especially for prevention and control studies." Clinical champions are important facilitators of CCOP participation because, as one interviewee explained, "It is important to have a physician leader. At the start of the program, there are political and clinical issues. And if there is no physician champion who helps to drive it, you cannot get it started." Another hospital's research nurse described its physician champion: "He is very dedicated. . . . We do have tumor boards [where different tumors are discussed in a multidisciplinary setting] here at the hospital every week ... for different sites of disease. And he talks to the physicians and asks them, 'Hey, you know, why aren't you accruing What can we do to make it better ' " The involvement of nurses as clinical champions was also reported as important.

DISCUSSION The challenges interviewees associated with CCOP participation were common across the CCOP organizations we studied and were consistent with reports of recent research highlighting issues such as leadership support, patient recruitment, and physician participation (e.g., Minasian et al., 2010; McKinney, Weiner, & Carpenter, 2006; Beckett et al., 2011). Given the important role of the CCOP and growing interest in the potential of PBRNs to promote patient access to scientific advances by expanding the reach of clinical trials, our findings could be perceived as troubling to policy makers and scientists because of the difficulties we uncovered. These challenges, however, may not be insurmountable. For instance, while factors related to the bureaucratic requirements of the CCOP may be beyond the control of hospitals and clinicians who participate in CCOP organizations, the five CCOP challenges - lack of appreciation of the CCOP's value, limited understanding of the initiative, needed workflow changes, issues related to managing CCOP operations, and the need to sustain administrative support - can be addressed. We explore this possibility later in our discussion of the implications of these findings for management practice.

Our findings about the challenges these interviewees perceived to be associated with CCOP participation suggest important opportunities for the NCI to support providers' involvement with CCOPs by reducing some of these barriers and emphasizing the benefits of participation. For instance, developing a means for organizations to document and quantify a business case could help providers justify and sustain their participation in the CCOP In light of the results of prior studies that have shown the need for quality improvement and health programs to demonstrate a business case to generate or sustain support from organizations (Leatherman et al., 2003; Reiter, Kilpatrick, Greene, Lohr, & Leatherman, 2007; Song, Robbins, Garman, & McAlearney, 2012), paying attention to the challenges associated with the perceived costs and operational impacts of CCOP participation may be especially important.

In this study we have also highlighted three factors that interviewees noted could facilitate CCOP participation: commitment, the presence of champions, and awareness. These facilitators are consistent with results reported from prior research focused on efforts to diffuse and implement innovations (e.g., Sales et al., 2006; Rogers, 2003; Klein & Sorra, 1996), especially in health services (e.g., Helfrich, Weiner, McKinney, & Minasian, 2007; Beckett et al., 2011). For instance, the critical role of champions in efforts to implement innovations has been emphasized in studies of technology implementation and organizational change in diverse healthcare settings (e.g., Poon et al., 2004; Miller & Sim, 2004; Nanji et al., 2009). Similarly, the notion of commitment is important for any change to succeed over time (e.g., Poon et al., 2004; Miller & Sim, 2004).

Particularly striking is our finding about the importance of awareness. The notion of awareness, as demonstrated in our study, is consistent with diffusion of innovation theory, which posits that knowledge is the first of five stages of the innovation-decision process (Rogers, 2003), and with prior studies that have highlighted the role of awareness in promoting behavior change (Prochaska & DiClemente, 1983). More recently, Beckett et al. (2011) conceptualized a decision-making model incorporating the work of Prochaska & DiClemente (1983) that emphasizes the importance of awareness in encouraging community physicians to participate in clinical trials research. The role of awareness in helping to facilitate CCOP participation was noteworthy because of its potential link to the other facilitators of commitment and the use of champions that emerged. Emphasizing and building awareness may thus help to create new champions and, ideally, enhance commitment to CCOP participation.

Management Implications Although the facilitators of CCOP participation were not proposed as direct solutions to the challenges raised, focusing on these three factors could help hospitals and physicians overcome such challenges. First, emphasizing commitment-administrative and clinical - can help address the challenges associated with implementing required workflow changes, managing patient recruitment and physician involvement, and sustaining administrative support. Second, the important role of champions can be leveraged when solutions to CCOP-related challenges require difficult changes, conversations (e.g., about patient recruitment and physician involvement), and budgetary decisions. Finally, awareness of the CCOP and its contributions to patient care may help build the support needed to implement and maintain the CCOP over time, particularly in the presence of financial challenges and competing demands. By taking these three factors into account, CCOP participants may find their challenges less burdensome as the value of this participation is better recognized and promoted.

Limitations Our study has several limitations. First, given our sample of five purposively selected CCOP organizations, our results represent the perceptions of the informants we interviewed and may not be representative of perceptions from different providers or CCOP organizations. However, we attempted to interview a broad sample of informants, including both administrative and clinical interviewees, and have confidence that the findings we report fairly represent interviewees' perspectives about challenges and facilitators of CCOP participation. Second, our study was constrained by the time frame in which it was conducted. Although changes in CCOP participation, NCI funding, research experiences, and other factors are expected over time, we were unable to study changes that could be directly attributed to our study design involving interviews conducted at one point in time. Third, while we highlight several opportunities to overcome CCOP participation challenges, our study was not designed to determine whether focusing on these suggested facilitators would be effective in practice.

Future Research Opportunities Future studies may overcome some limitations of this study by considering different designs and methodological approaches. For instance, by studying CCOP organizations that have successfully navigated participation challenges over time, future research can be designed to discover more about the factors that facilitate participation and those that lead to successful, sustained performance for CCOP organizations.

CONCLUSION CCOP participation is an important component of the NCI's strategy to promote PBRNs in the expansion of access to clinical trials for new and perhaps underserved populations. The challenges of CCOP participation are not trivial. Nonetheless, improving our understanding of these barriers and potential opportunities to overcome them may assist hospitals and physicians in increasing and sustaining participation in the CCOP and other PBRNs, thereby helping to preserve and extend critical access to innovative medical treatment options for patients in need.

ACKNOWLEDGMENTS The project described was supported by Award Number R01CA124402 from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. We thank Erin Schaffer, Padmini Ekbote, Alexandra Moss, and J. Phil Harrop for their assistance in early work on this study. No conflict of interest exists with this article.

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PRACTITIONER APPLICATION Patrick A. Grusenmeyer, ScD, FACHE, president, Christiana Care Health Initiatives, and senior vice president, cancer and imaging services, Christiana Care Health System, Newark, Delaware When reading an article on cancer research and the National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP), it may be easy for healthcare executives to get lost in the acronyms and seemingly arcane and distant research functions. The reality is that one in two men and one in three women will be diagnosed with invasive cancer sometime in their life, and they will seek care in our institutions. Although the death rate for heart disease has steadily decreased over the past several decades, the death rate for cancer has improved only marginally; as a result, cancer has surpassed heart disease and is now the leading cause of death in all persons except the very elderly. All of us know, personally and professionally, someone who has been diagnosed with or died of cancer.

The more important reality is that research cures cancers. The cancer community has made significant strides in curing cancers, particularly childhood cancers such as leukemia and early-stage adult cancers such as breast and colon cancers. It is also true that many cancers, particularly advanced cancers or those diagnosed in late stages, have proven incredibly complex and difficult to cure.

As a cancer program administrator for more than 15 years in facilities with NCI-funded CCOPs, I have experienced firsthand that good cancer programs incorporate significant cancer clinical research into their services. Clinical research involves patients; it does not take place in the laboratory. Physicians who participate in cancer clinical research, who recruit patients to and manage patients on clinical trials, are much more likely than other oncologists to utilize evidence-based care in treating their cancer patients and will more quickly incorporate the outcomes of new clinical trials into the care they provide. The outcome is substantially improved care for the patient.

In this article, McAlearney et al. identify seven challenges and three facilitators of participation in NCI-funded cancer research. Particularly important to hospital executives are the challenges of poor understanding, lack of appreciation, cost, and lack of hospital leadership support.

Healthcare executives face many issues in today's environment, particularly those related to quality and safety, reimbursement and operating margins, and changing models of care. Incorporating cancer clinical trials into a cancer program can improve patient quality and safety, but it can also lead to increased pressure on the bottom line, as clinical trials are not fully supported by the NCI.

In fact, only a limited number of hospitals and healthcare systems are funded by the NCI to carry out CCOP research activities. The NCI funds 47 CCOP grants and 16 minority-based CCOPs. Grant funding has become increasingly competitive as pay lines (the grant application evaluation score needed to qualify for a grant) have decreased (in the NCI process, counterintuitively a lower score is better). In addition, the NCI has announced the merger of its two community-based research programs, the CCOP and the Community Cancer Centers Program, into the NCI Community Oncology Research Program. Funding criteria, the grant application process, and scoring are still under development at the NCI.

Regardless of whether a hospital or healthcare system is NCI funded, it can participate in the cancer clinical trials process, as an affiliate of a funded CCOP or through the NCI's Clinical Trials Support Unit. To do so requires a commitment from leadership to support the clinical trials function, a commitment worth the resultsbecause research cures cancer.

(c) 2013 Health Administration Press

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