Corbie-Smith believes that race is a major factor in influencing health care delivery and access to care. One aspect of her research explores the long-lasting implications of the Tuskegee study conducted from 1932 to 1972. Below, a study participant has blood drawn for a syphilis test in the early 1950s. Courtesy of Centers for Disease Control and Prevention.

by Rhonda Mullen ost of the patients that Giselle Corbie-Smith sees in her clinic at Grady Memorial Hospital are African-Americans. Typically, her patients live in the inner city and face myriad challenges related to poverty, violence, lack of fulfilling job opportunities, and health. They are part of a population repeatedly identified in studies as being at risk for breast cancer, HIV, heart disease, and other chronic illnesses at double the rates of whites. For Corbie-Smith, they are daily visible proof that race and ethnicity do play major roles in influencing health care delivery and access to care. And they are precisely the population on which she wants to focus her efforts. Her interest in minority health issues began early in her academic career as a medical student at Albert Einstein College of Medicine, and it grew as she completed an internal medicine residency at Yale. Particularly as chief resident at Yale, she began noticing a disturbing trend, that physicians and fellow residents were making assumptions about patients based on race rather than risk factors. When patients were black, they often received a different diagnosis than white patients with similar symptoms and risk factors, Corbie-Smith noticed. On her own initiative, she completed a small, informal study of how race affected diagnoses and outcomes and found her initial observations were consistently true. National research studies validate Corbie-Smith's hypothesis. Of all racial groups, African-Americans live the fewest years, and they live a high proportion of those years with chronic health problems, write authors in Demography. Prostate cancer is the most common malignancy in US men, with substantially higher rates among blacks, according to a National Cancer Institute study published in Cancer Epidemiology. In a recent issue of Surgery, researchers reported that African-American women are seen with more advanced breast cancers, are less likely to receive breast-conserving surgery, and generally have a poorer prognosis than white women. In other areas, such as stroke and colon cancer, the prognosis for blacks is equally dim. Compared with whites, they have a two-fold increased risk for intracerebral hemorrhage, and researchers, who published their study in Neurology, predict that disparities are likely to continue. One way Corbie-Smith is addressing her interest in minority health issues is to work as a clinical educator at Grady, a public hospital in a region where many health status indicators for African-Americans are the lowest in the nation. In addition to her clinical duties, she has lectured in the internal medicine residency program on cultural awareness, cultural considerations for caring for African-American patients, and medical ethics. But she hasn't been content to stop there. She believes clinical research is also a necessary component to addressing these issues.

Prior to its desegregation in 1956, there were two Gradies, one for blacks and one for whites. Above, African-American patients wait in line at the hospital pharmacy. Courtesy of the Atlanta History Center.

hile her medical and residency training prepared Corbie-Smith well for clinical service, it fell short of giving her the necessary skills to conduct clinical research. "It's hard enough when you have the tools," she says. "It's impossible if you don't." At the time Corbie-Smith joined the School of Medicine faculty in 1995, no official program for such training existed at Emory. That scenario recently changed with the establishment of the Master of Science in Clinical Research (MSCR) degree -- a collaboration of Emory's schools of Medicine and Public Health that is offered under the auspices of the graduate school. The program is targeted initially at Emory clinicians like Corbie-Smith, who wish to pursue, or expand, careers in clinical investigation and evaluation. Eventually, the program, which is highly tailored to individual needs, hopes to accommodate 15 to 20 students each year. Emory's MSCR is in part a response to the alarming national trend documented in the 1997 Nathan Report, issued by the National Institutes of Health (NIH), which revealed a significant drop in the number of skilled clinical investigators and a decline in applications for NIH clinical research grants. That document articulated the belief of some members of the academic medical community that physician clinical researchers are a dying breed poorly supported by the NIH. The committee investigating the issue found that physicians or MD/PhD scientists do fall well behind PhD investigators in successfully receiving NIH awards in clinical research. Because it believes that physician investigators in particular make vital contributions to the nation's research effort, the panel recommended that the training of clinical researchers be strengthened, from medical student experiences through fellowships. The NIH responded by establishing not only competitive grants for two-year didactic training programs (one of which Emory recently received) but also a series of individual awards for young clinical investigators. Corbie-Smith is not only one of the students in Emory's first class pursuing the MSCR but she also has received one of the NIH awards for individual investigators. Her recognitions and accomplishments mark her as one of the up and coming doctors who are reversing the prognosis for physician researchers from a dying breed to having renewed commitment and vibrancy.

Corbie-Smith is examining the influence of race, social class, and psychosocial factors on recruitment and retention of subjects in the Women's Estrogen Stroke Trial.

ne focus of Corbie-Smith's research is to more fully understand the long-lasting implications of the Tuskegee syphilis study for clinical investigation. The Tuskegee study, conducted by the US Public Health Service, documented the course of syphilis in 400 black sharecroppers in Alabama from 1932 to 1972. The researchers failed to tell the men their diagnosis, to give them counseling on how to avoid the spread of the disease, or to treat them, thus creating the longest nontherapeutic experiment on humans in the history of medicine. However, many physicians still don't understand the lasting legacy of the Tuskegee study on doctor/patient relationships, according to Corbie-Smith. Even as recently as her residency training, she noted the omission of any discussion of Tuskegee by a lecturer who was discussing a resurgence of syphilis in the United States. "As physicians who will be caring for an increasingly diverse nation, it is important that we understand the lasting implications of this study for our patients," Corbie-Smith wrote in her recent article for the American Journal of the Medical Sciences. "The study has come to represent not only the exploitation of blacks in medical history, but the potential for the exploitation of any population that may be vulnerable because of race, ethnicity, gender, disability, age, or social class. However, the effects of the Tuskegee Syphilis Study are demonstrated most strikingly by unsuccessful attempts at improving representation of minority patients in clinical trials." In exploring the Tuskegee legacy, Corbie-Smith builds on the work of her mentor Stephen Thomas, a nationally recognized investigator of the study's implications for HIV/AIDS education and prevention programs in the African-American community and director of the Institute for Minority Health Research at the Rollins School of Public Health. His community-based research on AIDS, violence, and organ donation addresses the importance of interdisciplinary collaboration with research participants, nongovernmental organizations, and the biomedical research establishment as well as collaboration across the disciplines with both established and budding investigators like Corbie-Smith. In her continuing examination of Tuskegee, she found that its disclosure led to the creation of guidelines for the protection of human research subjects and established Institutional Review Boards at all institutions receiving federal research funding. While these initiatives were necessary and good for the protection of vulnerable populations, they led to overprotection, wherein investigators began excluding certain populations from clinical research to avoid the possibility of exploitation. Yet underrepresentation of minority patients in turn led to other problems, including generalization and application of research findings from a homogenous study sample to racially diverse populations, according to Corbie-Smith. In more recent years, when researchers have begun to recruit minority populations for studies as a requirement of the NIH, their efforts have frequently failed. "Public knowledge of the historical relationship between federally funded research and minority patients has contributed to a sense of distrust of the medical profession in general, and medical research in particular," writes Corbie-Smith. The initial step in solving this problem, she believes, is for investigators to first appreciate the significance of the Tuskegee study in recruiting minority patients for research studies. With that significance established, investigators should then approach minority patients with culturally sensitive methods to demonstrate that their work is ethically sound. Thomas likewise argues that "to build community trust, researchers must verify that participants are fully informed about research procedures, costs, risks, and benefits. This is the context in which the process of informed consent becomes a negotiated partnership between the researcher and participant, rather than simple adherence to legal procedures" (American Journal of the Medical Sciences). Still another strategy for dismantling the legacy of Tuskegee, according to Thomas, is a larger number of black physicians who are themselves skilled clinical researchers. "To eliminate the racial and ethnic disparities in health, we need a new kind of health care professional," he says. "Giselle Corbie-Smith is that kind of professional, someone on the front line."

Nurse Eunice Rivers (right) was the liaison between researchers and participants in the Tuskegee study, which has come to represent the potential exploitation of vulnerable populations in research studies, says Corbie-Smith. Courtesy of Centers for Disease Control and Prevention.

ecruitment of African-Americans to research studies can be successful, as shown by Corbie-Smith's collaboration on the Women's Estrogen Stroke Trial (WEST). Under the direction of Ralph Horwitz at Yale, the trial is based in 20 hospitals in or near New Haven. Corbie-Smith joined Horwitz's team in 1997 when the National Institute of Neurologic Disorders and Stroke awarded her a minority investigator supplement to WEST. She is examining the influence of race, social class, and psychosocial factors on the recruitment and retention of women in the study. Because minorities and individuals in low socioeconomic classes are overrepresented among patients with stroke, the research will be particularly important, says Corbie-Smith. Her preliminary analysis shows that the proportion of ethnic minorities in WEST is comparable to the general recruitment rate for all new participants. "These early results show that if you build a study design that considers the recruitment of African-Americans, you can succeed," she says. Also, in 1997, Corbie-Smith joined the Emory component of the Women's Health Initiative (WHI), the largest, randomized patient study in the NIH's history. The WHI is tracking the health of 160,000 women nationally for 12 years. In Atlanta alone, the study has enrolled 4,000. It is Corbie-Smith's job to oversee the adherence and retention of those 4,000 women in the study. Sally McNagny, then principal investigator of Emory's part of the WHI, invited Corbie-Smith to join her research team because of her ability and determination, she says. "We've developed an excellent collegial relationship," McNagny says. "I've been able to be a reality test for her for what to expect in a clinical research career." For one thing, McNagny told Corbie-Smith early on that she would have to work many times harder than other investigators because she had no fellowship training. For another, she encouraged her to seek out nationally recognized mentors. Corbie-Smith followed that advice, working closely not only with McNagny and Thomas at Emory but also Horwitz at Yale. Now with her studies in the MSCR program well under way, she's gaining more of the nitty-gritty skills needed by a clinical researcher in classes such as epidemiology, biostatistics, and clinical trials methodology. Managing time has been her biggest challenge. She does her homework at night after her kids go to bed. She teaches residents each Monday morning. She volunteers for teaching in the Emory Ethics Center, and she works with the Georgia Leadership Commission on Organ, Tissue, Blood, and Marrow Donation among African-Americans. The commission is searching for ways to address the critical shortage of organ donations from African-Americans. Where does she find the energy? "I have a fire in my belly for research," she says. Thomas describes Corbie-Smith as "a prototype for the kind of clinical professional the MSCR wants to train. She takes on the toughest challenges and thrives in the process of learning how to serve."