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© 1999 American Society for Clinical Oncology Recruiting Minority Cancer Patients Into Cancer Clinical Trials: A Pilot Project Involving the Eastern Cooperative Oncology Group and the National Medical AssociationFrom the Division of Cancer Prevention, National Cancer Institute/National Institutes of Health, Rockville, MD; Oncology Division, Stanford Medical Center, Stanford, CA; AMC Cancer Research Center, Denver, CO; Eastern Cooperative Oncology Group, Philadelphia, PA; National Medical Association, Merrillville, IN; and University of Colorado, Health Science Center, Denver, CO. Address reprint requests to Worta McCaskill-Stevens, MD, Division of Cancer Prevention, National Cancer Institute/National Institutes of Health, 6130 Executive Blvd, Room 300, Rockville, MD 20852; email wm57h{at}nih.gov
PURPOSE: Minority accrual onto clinical trials is of significant interest to cooperative oncology study groups. The Eastern Cooperative Oncology Group (ECOG) conducted a study to identify barriers and solutions to African American accrual onto clinical trials. METHODS: We hypothesize that the National Medical Association (NMA) might provide insight into ways to increase minority participation and that ECOG might facilitate that participation. Four sites were selected in which NMA chapters existed and ECOG main institutions with less than half of the corresponding percentage of minorities in their communities entered trials for 1992. Fifteen workshops were conducted using discussions and open-ended, self-administered questionnaires. RESULTS: Seventy percent of NMA physicians cited mistrust of the research centers, fear of losing patients, and a lack of respect from ECOG institutions as the most important barriers to minority cancer patient referrals, compared with 30% for ECOG physicians. Sixty-nine percent of NMA and 43% of ECOG physicians cited a lack of information about specific trials. Nearly half of NMA physicians (47%) cited a lack of minority investigators as a barrier, compared with 4% of ECOG physicians. Solutions by both groups were improved communication (73%) and culturally relevant educational materials (40%). ECOG physicians cited more minority outreach staff as a potential solution (22% v 6%). NMA physicians cited increased involvement of referring physicians (44% v 4%). CONCLUSION: NMA physicians who serve a significant sector of the African American population demonstrated a willingness to participate and work with a cooperative group effort to increase participation of minority patients and investigators.
OVER THE PAST SEVERAL years, increasing attention has been paid to the issue of maximizing accrual to clinical trials. State-of-the-science therapy in cancer treatment is defined and disseminated by clinical trials research. Participation in cancer clinical trials is estimated to be as low as 3%. It is reported that participation in treatment trials sponsored by the National Cancer Institute (NCI) generally parallels the incident burden of disease among non-Hispanic African Americans, Hispanics, and non-Hispanic whites, which suggests equal access to clinical trials.1 However, it is also known that the majority of patients enrolled onto clinical trials are middle class regardless of race or ethnicity and that significant barriers and problems persist in the accrual process.2 In addition, participation of minority cancer patients in prevention trials has been dismal.3 Cooperative clinical trial groups throughout the nation have begun to evaluate the accrual of minorities who enroll onto national cancer treatment and prevention studies. The impetus to pursue the problem of accrual of minorities onto clinical trials arises from three well-recognized problems: (1) a significant disparity in mortality rates between minority and white cancer patients in several tumor sites; (2) the differences in stage of disease at the time of diagnosis; and (3) a growing need to distinguish the impact of socioeconomic status from race on the primary treatment outcomes of disease-free survival, toxicity, and overall survival. In addition, there are concerns about patient acceptance of prevention regimens and adherence to treatment trials. To study all of these factors efficiently and effectively, adequate numbers of minority patients are needed. These concerns resulted in the National Institutes of Health (NIH) issuing guidelines in 1994 for the inclusion of women and minorities as subjects in clinical research.4 These guidelines stated that the NIH must (1) ensure that women and members of minorities and their subpopulations are included in all human subject research, (2) ensure that women and minorities and their subpopulations are included in phase III clinical trials so that valid analysis of differences in intervention effects can be performed, (3) not allow cost to exclude these groups, and (4) initiate programs and support for outreach efforts to recruit these groups into clinical studies. The NIH initiative presupposes that investigators truly understand the barriers to minority patient accrual to clinical trials. Barriers to patient accrual to clinical trials identified in previous research cover a wide spectrum of problems, ranging from patient beliefs about the value of clinical trials and the efficacy of specific treatment protocols to physician perceptions about the demands that would be placed on their time if they participated in clinical trials research. For example, general barrier categories have been identified in terms of historical, economic, social, and cultural issues,5 as well as in terms of availability, affordability, accessibility, and acceptability of clinical trials for minorities.6,7 Swanson and Ward8 have recently classified barriers to minority recruitment into four general areas: (1) sociocultural barriers, (2) research barriers, (3) economic barriers, and (4) individual barriers. The impact of these barriers affects minority health care providers as well as minority patients. Three major barriers identified by Swanson and Ward8 that pertain specifically to physicians include (1) the time required for the physician to participate in trials, (2) interference with the doctor/patient relationship, and (3) conflict between the role as caregiver and scientist. Limited studies have been published that address the participation of minority physicians in clinical research, and even fewer have addressed the participation of minority physicians in cancer clinical trials. Minority physician participation in clinical trials is characterized by many of the barriers that have been reported to affect the participation of minority patients. The small percentage of minority health care professionals in academic medicine, and specifically in the oncologic specialties, is a significant barrier to the influence that minority health providers might have upon the participation of minority patients in cancer clinical trials. In response to this concern, the Society of Cancer Researchers Advocating Therapeutic Excellence for Special Populations (SOCRATES) was established. SOCRATES, which is composed of African American clinical oncologists who are members of the National Medical Association, the American Society of Clinical Oncologists, American Society for Therapeutic Radiology and Oncology, and other large cooperative cancer clinical trial groups, proposes to maximize the benefits of resources directed at the health needs of African Americans.6 The "Tuskegee Experiment,"9,10 in which African American men with syphilis were left untreated for years, is a barrier that has engendered fear and mistrust of clinical research, especially among members of the African American population. Misuse of African Americans by the United States health care system existed long before Tuskegee, however, as documented by the use of African Americans as research subjects for autopsies, dissections, and experiments during slavery for medical student training in southern medical schools.11,12 These historical occurrences are not forgotten in the African American community.10 In recent years, African Americans were reluctant to participate in clinical trials to test new AIDS treatments, citing a fear of a government conspiracy.13 Historical incidents, along with individual stories of mistrust and fear of research institutions, create an atmosphere of distrust among African Americans that still surrounds clinical research. Both African American physicians and their patients are products of this culture of mistrust. A common reason that cancer patients are not enrolled onto clinical trials is that the patient's physician makes a decision not to refer or recommend the trial to the patient. Although systems to safeguard the rights of clinical study participants have been instituted, including the creation of institutional review boards and stringent requirements for patient informed consent, mistrust of the system persists. The Tuskegee legacy poses critical questions about how to approach African American patients about clinical trial participation, as well as how to design and administer trials to engender more trust within the African American community regarding clinical trials research. In January 1996, a conference on the Recruitment and Retention of Minority Participants in Clinical Research, sponsored by the National Cancer Advisory Board, National Cancer Institute, American Cancer Society, Oncology Nursing Society, Office of Research on Women's Health, and the Office of Research on Minority Health, reviewed the state of science on how to recruit and retain minority participants.14 Panelists presented useful experiences and strategies that addressed payment policies, clinical trials public education, and cultural factors that play key roles in the enrollment of minorities onto clinical studies. The major focus of this conference was outreach support and identification of cultural uniqueness of patients from different minority subpopulations. The Eastern Cooperative Oncology Group (ECOG) is an international organization devoted to the study and cure of neoplastic disease. It is composed of physicians, nurses, data managers, and pharmacists and includes 25 university institutions and several hundred affiliates, Cooperative Group Outreach Programs, Community Clinical Oncology Programs, and Minority-Based Community Clinical Oncology Programs (MBCCOPs) supported by the NCI. In April 1993, a workshop to review barriers to accrual of minority cancer patients onto clinical trials was conducted. This workshop proposed a series of outreach efforts to increase accrual of minority cancer patients from non–ECOG-affiliated institutions and community physicians. After this workshop, the decision was made to form the ECOG Minority Accrual Initiative. The minority group specifically targeted in this initiative was African Americans, due in part to the existing relationship of the coinvestigators as members of the National Medical Association (NMA). However, another factor that encouraged collaboration with the NMA was the fact that the majority of patients seen in the medical practices of African American physicians are African American.15,16 Thus, the position held by NMA physicians as primary caregivers to African American patients may provide increased access to this patient population for inclusion in clinical trials. The NMA is an organization of 22,000 African American physicians, two thirds of whom are primary care physicians. Founded in 1895 in Atlanta, GA, the organization promotes the science and art of medicine. It acts to influence society and its institutions and to encourage, protect, and promote the betterment of the public health and quality of life for individuals and families. State and local societies exist in more than 31 states and the Caribbean. In African American communities, the role of the African American physician continues to be one of leadership in the community as well as that of health care provider for a significant portion of African Americans. In a recent study addressing the role of African American and Hispanic physicians who provide health care in California, it was reported that African American physicians cared for 25% more African American patients than did other physicians. In multivariate analyses, the only characteristic that predicted whether a physician provided health care to a high proportion of African American patients was the race of the physician (African American).17 In this article, a small-scale pilot project is described involving collaboration between ECOG and the NMA. The main objectives of this pilot project were to gain a better understanding of the barriers and potential solutions to low accrual of minority cancer patients into clinical trials and to implement (as a pilot project in a small number of communities) several low-cost strategies to overcome these barriers. This article provides a general description of the pilot project, the barriers and solutions that were identified, and the low-cost strategies that are now being implemented by ECOG and selected local chapters of the NMA.
Overview Figure 1 provides an overview of the research design for the ECOG minority accrual pilot project. As shown, seven ECOG-affiliated institutions in three cities were eventually selected to receive the minority accrual outreach intervention, while a matched set of 22 ECOG institutions in 19 cities served as the control. The intervention, which is described in more detail below, relies on a sequence of five workshops/meetings with ECOG (university-based) physicians as well as physicians affiliated with the NMA. The success of the intervention will be assessed at 2-year follow-up by comparing the percentage increase in minority cancer patient accrual in the intervention institutions versus the control institutions. The main research hypothesis is that the intervention communities will show at least a 100% increase in minority cancer patient accrual, whereas the control sample will show little or no change.
Selection of Sites These 37 ECOG institutions were further examined to determine which had a percentage of minority patients accrued onto clinical trials in 1992 that was less than half the corresponding percentage of minorities in the surrounding community (on the basis of 1990 United States Census data). If the percentage of minority patients accrued onto clinical trials was more than half the corresponding percentage of minorities in the surrounding community, the institution was deleted from the list. If, on the other hand, the percentage of minority patients accrued onto clinical trials was less than half the corresponding percentage of minorities in the surrounding community, the institution was retained on the list. On the basis of this criterion, eight additional institutions were deleted, leaving 29 ECOG institutions from 22 cities. From this list of 29 ECOG institutions in 22 cities, four communities representing seven ECOG institutions were initially selected to participate in this demonstration project. These four communities were Indianapolis, IN, Cleveland, OH, Philadelphia, PA, and Santa Clara/San Mateo County, CA. These communities were selected on the basis of the following additional criteria: (1) the principal investigator of the main ECOG institution(s) in the area expressed an interest in participating; (2) the main ECOG institution(s) had at least five active ECOG clinical trials (at the time of site selection); (3) the local chapter of the NMA was active in the area; and (4) the local NMA leadership expressed an interest in participating in the pilot project. However, as will be noted below, one of the targeted communities (Santa Clara/San Mateo County, CA) was subsequently dropped from the study because the local ECOG leadership was undergoing extensive turnover at the time this project was being implemented. The 22 ECOG institutions in the remaining 19 cities will serve as the control group in this demonstration project.
Physician Workshops In the first three workshops, invitations were extended to a core group of physician-leaders who were specifically recruited to serve as idea champions with their colleagues. Within the university setting, these physicians were typically clinical directors, physicians already actively involved in ECOG, and/or physicians who had access to large numbers of cancer patients. Within the NMA, the local physician leadership was targeted, as well as physicians who had access to large numbers of cancer patients, including primary care physicians. For the first workshop, separate meetings were convened for ECOG and NMA physicians. The main objectives of this first meeting were to provide these physician-leaders with an overview of the ECOG minority accrual initiative and to stimulate discussions about physician and patient barriers to clinical trials. Discussions were also held about potential solutions to these barriers. The decision to conduct separate meetings was made to encourage an open, uninhibited discussion that might be difficult to achieve if both groups of physicians were brought together at the outset. Approximately 10 to 12 physicians attended each meeting, which lasted approximately 2 hours. At the conclusion of this first meeting, both groups of physicians completed a self-administered questionnaire that included questions on perceived barriers to clinical trials, as well as potential solutions to these barriers. These questions were primarily formatted as open-ended questions. Also included in the survey was a question asking physicians what ECOG could do to increase enrollment of minority patients into clinical trials, as well as the likelihood that they would try to increase the number of their patients referred to clinical trials. After the second workshop, the participants were asked for a commitment to continue the process to develop and implement solutions to the identified barriers. At the end of the second meeting of the Santa Clara/San Mateo, CA, group, only one third of the participants were interested in working together to develop these solutions. Because of this lack of commitment, this site was dropped from further intervention and the Tables do not include responses from this group. The second and third workshops involved the same core group of physician-leaders, who were invited to attend the same dinner meeting. In the second workshop, results from the self-administered survey completed at the first workshop were shared and discussed. Guided discussions also occurred with respect to potential strategies to increase minority accrual. Another self-administered questionnaire was completed at the end of the second workshop. This survey once again asked participants what ECOG could do to increase minority accrual. Another question requested specific suggestions on how the dissemination of information about clinical trials might be improved for community physicians. In the third workshop, results from the second self-administered questionnaire were shared and discussed. In addition, selected ECOG trials were presented for group discussion. The number of trials presented at the third meeting varied from city to city, depending on the perceived interest and accrual potential within each local chapter of the NMA and availability of the trial in the local community. However, to illustrate the process of patient referral, all three cities were presented with the same set of four ECOG clinical trials. These four clinical trials were the following: (1) Breast (S9313): Phase III Comparison of Adjuvant Chemotherapy With Hi-Dose Cyclophosphamide + Doxorubicin Versus Sequential Doxorubicin Followed by Cyclophosphamide in High-Risk Patients With 0-3 Positive Nodes; (2) Colorectal (C9270): Colorectal Cancer Prevention Trial Using Aspirin: A Phase III Study; (3) Prostate (S9217): Phase III Trial of Chemoprevention of Prostate Cancer With Finasteride (Proscar; Merck & Co, Whitehouse Station, NJ)–Intergroup; and (4) Lung (91025): Phase III Double-Blind Randomized Trial of 13-Cis Retinoic Acid to Prevent Second Primary Tumors in Stage I Non–Small-Cell Lung Cancer. At this third workshop, the physician-leaders were asked to indicate the likelihood that they would recommend each of these four clinical trials to their patients. The fourth workshop involved a special dinner meeting hosted by the local chapter of the NMA. The full membership of the local NMA was invited to this dinner meeting, along with selected physician-leaders from the university. Attendance varied from approximately 25 (Philadelphia) to eight (Cleveland). Attendance at the Cleveland meeting probably suffered because the workshop was scheduled as a separate, stand-alone meeting, whereas in Indianapolis and Philadelphia, the dinner meeting was convened as one of the regularly scheduled meetings of the local NMA. At each of these workshops, Dr. Otis Brawley from the NCI gave a keynote address stressing the importance of minority cancer patient accrual to clinical trials. The same core group of ECOG clinical trials was highlighted and discussed. Local physician-leaders who attended the earlier workshops also endorsed the ECOG minority accrual initiative at this dinner meeting. The fifth and final workshop involved a dinner meeting that was also hosted by the local chapter of the NMA. The purpose of this final meeting was to provide a forum for addressing any remaining issues pertaining to minority patient accrual onto ECOG clinical trials. Attendance ranged from six to 16 participants per community, with most of the physicians affiliated with the NMA. NMA physicians who had made referrals to ECOG institutions were provided an opportunity to share their experiences with other NMA members. At the conclusion of these meetings, physicians were again asked to complete a brief survey. Included in the survey was a question asking them to indicate the likelihood that they would try to increase patient referrals to each trial that was reviewed. Another question asked physicians if they had enough information on how to refer patients to clinical trials and whether they found the dinner-meeting workshop useful.
The results reported herein were obtained mainly from workshops 1 and 3, which involved a purposive (focus group) sample of ECOG-affiliated physicians with extensive previous experience in clinical trials research and selected physician-leaders from participating local chapters of the NMA. Although individual physician participation varied across the dinner-meeting workshops, a general profile of the physician participants did emerge. Depending on the workshop, between 15 and 30 physicians typically attended, with approximately 50% to 60% affiliated with the NMA (Table 1). All NMA physicians were African American, whereas nearly all ECOG-affiliated physicians were European American. Approximately 25% of NMA physicians had previous experience enrolling patients onto clinical trials, although none reported extensive previous experience with respect to cancer clinical trials. Participating NMA physicians represented a variety of medical specialties (eg, primary care, obstetrics/gynecology, urology, and surgery), whereas ECOG-affiliated physicians were concentrated in medical oncology, surgical oncology, and urology.
Across all workshops, four key themes or issues were explored: (1) the extent to which physicians found the workshops useful; (2) the key barriers preventing both physicians and patients from participating in cancer clinical trials; (3) the solutions or corrective actions that might be taken to increase minority cancer patient accrual to cancer clinical trials; and finally, (4) whether physicians would refer their patients to cancer clinical trials. Results pertaining to each of these four themes are presented below.
Physician Ratings of the Workshop Dinner Meetings
Barriers to Patient Accrual Into Cancer Clinical Trials
Another prevalent barrier, which is also fundamental to the process of referring patients to clinical trials, was a lack of awareness on the part of NMA physicians regarding the availability of specific trials in their community (Table 2). Sixty-nine percent of NMA physicians cited this as a major barrier to cancer clinical trial participation. Interestingly, this issue was often framed by NMA physicians as one of unequal access to new therapeutic advances in the treatment of cancer. NMA physicians believed that their patients did not have equal access to promising new therapies because NMA physicians were essentially "out of the loop" and thus unaware that such trials existed or that their patients had access to these trials. Unlike the previous barriers cited by NMA physicians, this obstacle to physician participation in clinical trials seems imminently more manageable. As one NMA physician was quoted as saying at the first dinner meeting, "If you build the bridge, we will walk to the other side." Interestingly, ECOG physicians were somewhat less likely than NMA physicians to cite lack of information about specific trials as a barrier to clinical trial participation, and they were substantially less likely than NMA physicians to cite a lack of trust and respect as an obstacle to clinical trial participation. Another noteworthy difference between NMA physicians and their ECOG counterparts is the belief that the lack of a proven therapy will impede accrual of minority patients into cancer clinical trials. As shown in Table 2, NMA physicians were about twice as likely to report this concern than ECOG-affiliated physicians. For the most part, the remaining barriers to clinical trial participation had to do with the specific demands or inconveniences associated with conducting clinical trials research. Thus, insufficient resources for patient recruitment were mentioned, as well as the complexity of the trial and excessive eligibility criteria. Both NMA and ECOG physicians were quick to note that complex trials required much more time of the referring physician in terms of explaining the trial to eligible patients. Both NMA and ECOG physicians also expressed concern about the amount of paperwork required to enroll patients onto clinical trials. However, these concerns regarding insufficient resources were reported with greater frequency by ECOG physicians, which may reflect their more extensive previous experience participating in clinical trials research. Physicians participating in the workshops were also asked to identify what they perceived as the major barriers to clinical trial participation from the perspective of their patients. Again, results across the first three workshops were highly consistent. As shown in Table 3, results from the first workshop indicate that patient suspicion, fear, and family resistance related to fear and suspicion were rated as the top patient barrier by both NMA and ECOG physicians. This general barrier was mentioned far more frequently than other barriers, some of which included the previously cited physician barriers (eg, physician's lack of awareness of existing clinical trials and reluctance of physician to refer patients to the medical center sponsoring the trial). Table 3 also reveals that NMA physicians were far more likely to cite the lack of minority physician investigators as a barrier than ECOG physicians (47% v 4%). At the bottom of the list were economic barriers to patients and not approaching patients in a culturally sensitive manner.
The physician-defined patient barrier having to do with fear and suspicion prompted considerable discussion at the workshop dinner meetings. Both NMA and ECOG physicians believed that this was a major obstacle, and on more than one occasion, the legacy of the Tuskegee experiment was cited as a reason for suspicion and fear among African American patients. This discussion almost always returned to the need for patient education materials that would assure patients of the protections provided by the local institutional review board review process, as well as the need to involve minority physicians as coinvestigators in clinical trials.
Suggested Remedies to Patient Accrual Barriers
Physician Willingness to Refer Patients to Cancer Clinical Trials
Another question asked of physicians during the third workshop was how successful they thought the workshop will be in terms of actually increasing the number of minority cancer patients enrolled onto clinical trials (very, somewhat, not very, or not at all successful). Overall, 48% of physicians rated the third workshop as very successful, and all remaining physicians (52%) rated the workshop as somewhat successful. NMA and ECOG physicians had similar responses to this question (eg, 44% of NMA physicians reported that the workshop was very successful, compared with 53% of ECOG physicians).
It must be recognized from the outset that the NMA physicians participating in this study were not representative of their colleagues within the NMA. They were specifically recruited into this study because of their local leadership within the NMA. Nonetheless, their attitudes and beliefs about clinical trials are highly significant from a programmatic and policy perspective, because efforts to mobilize the NMA at the local level will need to involve these physician-leaders in a fundamental way. Thus, it is of interest to note that these NMA physician-leaders expressed a strong desire to recommend clinical trials to their patients. However, it must also be noted that these physicians also reported significant barriers to patient recruitment. Among the most prevalent barriers reported by NMA physicians was a lack of trust of the medical center sponsoring the trial. It is instructive to note that a lack of trust on the part of the referring physician has often been cited as a major barrier to clinical trials accrual.8 This physician barrier is frequently expressed as a concern or fear about losing patients to those physicians or institutions who are conducting the trial. However, in the case of NMA physicians, this issue encompasses more than concern about losing patients. It also includes a perceived lack of respect for minority physicians, which is manifested in such indicators as the lack of minority physicians who have tenured academic appointments at the institutions sponsoring the trial, the lack of communication that exists between academic institutions and minority physicians in the community, and the lack of minority physicians who occupy leadership roles (eg, study chairpersons and cochairpersons) within clinical cooperative groups. This variation on the lack-of-trust theme should not be overlooked, because it will likely require remedial action that goes beyond good intentions to include forming fundamental behavioral partnerships with minority physicians in the community. For example, efforts by the NCI to improve access to minority patients is reflected in the development of Community Clinical Oncology Programs. Such programs were designed to provide community physicians with access to cancer clinical trials. The MBCCOPs were initiated in 1990 to expand the clinical trials network of the NCI to minorities. The objectives of the MBCCOPs were as follows: (1) to bring the state-of-the-art treatment and prevention to minority patients in their communities; (2) to provide a basis for involving a wide segment of the community in clinical research; (3) to provide an operational base for reducing cancer incidence and mortality; (4) to facilitate wider community participation in future treatment and prevention of cancer; and (5) to examine recruitment and accrual in the MBCCOPs.18 However, the formation of the MBCCOP has not demonstrated any significant increase in the number of minority physicians in clinical trials as investigators. Another barrier receiving widespread support among NMA physicians was a lack of awareness and/or information about specific trials. Other barriers reported less frequently by NMA physicians had to do with the specific demands and inconveniences associated with enrolling patients onto clinical trials (eg, the time involved in explaining complex trials to patients and excessive paperwork). However, the relatively low frequency with which these latter barriers were reported must be interpreted with caution. Participating NMA physicians did not have a great deal of previous experience to draw upon with respect to cancer clinical trial participation. It is conceivable that as NMA physicians become more experienced in cancer clinical trial research, barriers having to do with insufficient resources and additional demands on their time will become increasingly prominent, along with the difficulty of explaining to patients the requirement for randomization that attends many clinical trials, with the latter representing another frequently cited barrier in previous research.8 Barriers having to do with a lack of information or awareness of specific trials are perhaps the easiest of all barriers to remedy. Indeed, NMA physicians were quick to suggest several practical solutions, including patient and physician brochures and other forms of communication. In response to these suggestions, ECOG subsequently developed both a patient brochure and a physician newsletter, as well as a laminated pocket card for physicians. The tri-panel, multicolor patient brochure was printed on heavy stock paper with an African-heritage Kinte cloth pattern and included graphic representations of an African American physician and patient. The brochure provides a brief description of clinical trials research and why such research is important, what some of the benefits and potential drawbacks are to participation in clinical trials research, what the patient can expect in terms of receiving information about a specific trial, including the general content of the informed consent statement, and the protection that is afforded to patients by their local institutional review board. This latter theme was included in the brochure in response to the perceived patient barrier having to do with fear and suspicion of clinical trials research (Table 3). The brochure also listed several key questions that patients should ask the referring physician regarding participation in clinical trials (eg, purpose of study; short-and long-term side effects; length of the study; and whether there are extra costs, and if yes, who pays). Also developed for patients were special inserts for the brochure that described in lay terms the core group of the four ECOG clinical trials identified earlier (one insert per trial). These inserts were designed to provide physicians with easily updated information on newly activated clinical trials. The physician newsletter developed for this project was tailored to each of the three cities participating in this project. The newsletter was designed to reinforce the central message of referring eligible patients to clinical trials, as well as to provide an update on the number of minority patients in each city who had been enrolled onto ECOG clinical trials, using 1994 as the baseline. Specific columns in the newsletter described the role of clinical trials research and why minority cancer patient participation is important. These newsletters also included guest columns from local physician-leaders encouraging minority cancer patient accrual, as well as specific information on how to enroll a patient onto a given trial. Thus far, one newsletter has been produced and mailed to all NMA physicians in each community as well as to selected ECOG physicians in these same communities. To help publicize the availability of the above-described patient brochure and clinical trial inserts, samples of these materials and a special order form were included in each newsletter. Finally, the laminated pocket card for referring physicians provided a brief overview of how to enroll patients onto cancer clinical trials. Included on the laminated card were the following recommendations: (1) become familiar with relevant cancer clinical trials offered in the local community by calling the Cancer Information Service of the NCI and especially the Physician Data Query System of the Cancer Information Service (relevant telephone numbers were provided); (2) arrange a telephone consultation with the investigator handling the trial in the local community to review the purpose and details of the trial, including eligibility criteria; (3) approach the patient and describe the clinical trial process and the special details of the trial for which the patient may be eligible; and (4) prepare a written summary of the patient's history (eg, pathology report, relevant diagnostic imaging, and histologic and cytologic slides), which would normally be hand-carried by the patient to the oncologist, along with the recommendation not to treat the patient because such treatment may render the patient ineligible for the trial. As noted previously, NMA physicians reported a desire to become more involved in the planning of ECOG clinical trials and to have an opportunity to function as full partners within ECOG. Clearly, both of these requests would help remedy concerns about trust and respect that were mentioned so frequently by NMA physicians. In response to these requests, the ECOG Operations Office and Dr. Edith Mitchell (Director of Special Populations, ECOG), in collaboration with the national office of the NMA, convened a joint symposium ("Minority Patients in Clinical Research: The ECOG Experience") at the April 1997 national meeting of ECOG. Selected NMA physician-leaders from the three targeted communities were in attendance, along with over 100 physician investigators from ECOG. A keynote presentation was made by the President of the NMA (Dr. Randall Morgan). Presentations were made by the Director of ECOG (Dr. Robert Comis), as well as by other key representatives of both the NMA and ECOG, including the immediate past President of the NMA, Dr. Yvonnecris Smith-Veal. A presentation from the NCI's Director of the Cancer Therapeutic Evaluation Program (Dr. Michaele Christian) was included. Specific recommendations made at this joint symposium included the following: (1) inviting NMA physician-leaders to attend various disease- and modality-oriented committees of ECOG to collaborate in the development of new cancer treatment protocols; (2) implementing a series of workshops at the national ECOG meetings to assist NMA physician-leaders in becoming study chairpersons and cochairpersons of ECOG-sponsored trials; (3) inviting ECOG physician investigators to the national NMA meeting to learn more about the NMA, and to make presentations to the NMA membership regarding the importance of clinical trial participation and the availability of specific trials for patient recruitment; and more generally, (4) to implement a mentoring program in which NMA physician-leaders could become more knowledgeable about ECOG and the development of ECOG protocols, from concept development to final NCI approval of a clinical trial protocol, for the purposes of preparing these physician-leaders to become study chairpersons and cochairpersons within ECOG. Partnerships between minority communities and research institutions have rarely involved minority physicians, and when these physicians have become involved, it is usually long after the planning stages of the clinical study. Most of the partnerships are composed of nonphysician health care providers, many of whom are trained by the sponsoring institution. Implementation of the above four specific recommendations has the potential to nurture minority primary care physicians as gatekeepers in the current health care environment and increase their knowledge base regarding cancer treatment and prevention. Our study found that both NMA and ECOG physicians recommended an increased role of minority health care providers in clinical research. The increased visibility of minority physicians participating in cancer clinical trials could also serve as a model to minority medical students and increase the number of research oncologists from the African American community. The initial 3-year ECOG minority accrual pilot project was completed in April 1997, with the joint symposium that was convened by the ECOG Operations Office and the national office of the NMA. During this 3-year period, 15 physician workshops were convened with NMA physician-leaders from three targeted communities. On the basis of results obtained from these workshops, a patient brochure and physician newsletter and pocket card were developed that will continue to be distributed by ECOG, along with a commitment from ECOG to continue their efforts to integrate NMA physicians into the fabric of ECOG. Only time will tell whether these low-cost communication materials will be effective in facilitating minority cancer patient accrual onto clinical trials. However, data obtained from the fifth workshop, which followed the unveiling of the brochures, newsletters, and pocket cards to NMA physicians, suggest a promising start in this regard. Thus, when asked whether they had sufficient information on how to refer a patient to an NCI clinical trial, 96% of participating physicians answered in the affirmative (ECOG physicians, 100%; NMA physicians, 95%). As this minority accrual initiative continues to unfold, ECOG will continue to monitor minority cancer patient accrual to their clinical trials, pursuant to the research design presented in Fig 1. It is hoped that future analyses will document a significant increase in minority cancer patient accrual within the three target communities, which would then provide the evidence necessary to expand this pilot project to all of ECOG, and perhaps to other clinical cooperative groups as well. At its most fundamental level, what is at stake in projects such as this is equity, that is, ensuring that all cancer patients have equal access to promising new cancer therapies. However, equity is not the only issue. When subgroups of cancer patients are not represented in sufficient numbers to support key subgroup analyses, the science of clinical trials research may also suffer. For example, response to therapy, toxicity, and even survival may differ by racial/ethnic subgroup independently of stage at diagnosis, treatment regimen, or other prognostic indicators. The investigation of such issues, which is critical to the development of effective cancer treatment and prevention, cannot occur if minority patients are underrepresented in clinical trials. Indeed, for some clinical trials, it may be necessary to oversample minority patients to ensure that adequate numbers are available to conduct high-priority subgroup analyses. Moreover, the current mechanisms of minority accrual into NCI clinical trials may not accurately reflect the diversity of the African American population. The sociodemographic characteristics of patients served by NMA physicians may enable a more diverse sample of minority patients to be included in clinical trials, thereby increasing the chance of finding important biologic differences if they exist. Thus, if appropriate representation of minority cancer patients is to occur, a fundamental and equitable partnership must be forged with physician gatekeepers from the community, which, for minority cancer patients, must involve organizations such as the NMA. Finally, if the goodwill and favorable intentions of these physician gatekeepers in the community is to be nurtured and sustained over time, the NCI may need to respond to the more resource-specific barriers to patient recruitment (eg, time required to explain complex trials to patients, excessive paperwork, and lack of data management support) that were not emphasized by the NMA physicians participating in this pilot project, perhaps because they did not have extensive experience in conducting clinical trials research.8 These resource-specific barriers, which have been well documented in previous research, may require the allocation of additional resources to physicians who practice in the community and provide critically important access to underserved patients in the United States.
We authors gratefully acknowledge the numerous NMA and ECOG physicians who participated in the workshop dinner meetings that were conducted in Indianapolis, IN, Philadelphia, PA, Cleveland, OH, and San Mateo County, CA, specifically local NMA chapter presidents Andrew Moore, M D, Winston Stubbs, MD, Billy Brown, MD, and James O. Wyatt, MD, for their assistance in identifying focus-group participants. We also thank AMC Cancer Research Center staff member Martha Tenney, MPH, for providing project manager support. Finally, we acknowledge the considerable support provided by Dr. Otis Brawley of the NCI, who made a special presentation on behalf of this project at the fourth workshop dinner meeting in each of the three participating communities.
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Copyright © 1999 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
