The objective of the Clinical Research Center (CRC) at MMC is to support clinical research to improve the health of African Americans and other populations with health disparities, and to increase the nation's pool of minority physicians and dentists carrying out clinical research.
The specific aims are: 1) to strengthen the administrative infrastructure of the CRC and to diversify the clinical research activities in the CRC by developing initiatives in oral health, community health, clinical pharmacology, and a collaborative clinical research network; 2) to increase the type and quality of direct research support available to both junior and experienced clinical research faculty; and 3) to increase the number of medical and dental faculty conducting clinical research using the CRC.
Aim 1 is to strengthen and expand the CRC and will be achieved by developing a core management team (MT) to improve resource utilization, financial management, to provide assistance to investigators with clinical trials, and to prepare timely management reports. The Associate Director of Oral Health Disparity Research will provide leadership for increasing dental faculty clinical research. A Research Subject Advocate (RSA) will ensure that the safety of research subjects is accorded the highest priority. To diversify clinical research, the CRC will develop collaborative research with community health centers and other RCRll clinical research centers, as well as a clinical pharmacology program.
Aim 2 will increase the type and quality of direct research support, which will be accomplished by hiring a biostatistician/epidemiologist with clinical trial experience and a data analyst to meet increasing requests for assistance with clinical study design, study methodology, data management, and manuscript preparation. Two research assistants, a bilingual research nurse and a community field research nurse, will be added to improve patient recruitment and community outreach, and to accommodate the increasing number of researchers and types of clinical research activities. In year 02, a bioinformatics manager will be hired to develop and integrate computational tools to facilitate multidisciplinary clinical research. In year 03, a clinical pharmacologist will be hired to develop and implement clinical pharmacology studies within the CRC.
Aim 3 involves strategies for increasing the number of MMC clinical researchers in medicine and dentistry, including short-term 'seed' funding to stimulate investigator-initiated research projects, and long-term funding for faculty-developed clinical research projects, which have the potential for extramural funding. Other faculty development initiatives include: 1) monthly CRC Clinical Science Seminars; 2) interdisciplinary Clinical Research Seminars; 3) an annual symposium on health disparities research; 4) grantsmanship workshops; and 5) courses on clinical research for faculty, residents, and students. With these enhancements, the CRC will take on a leadership role in the expansion of clinical research at the college and will become a national source of expertise on clinical research targeting health disparities. The CRC Administrative Core (AC) is responsible for providing leadership, management of the daily operation of the CRC, recruitment of new staff, and for the formulation and implementation of initiatives to enhance clinical research at MMC.
Specific Aim 1 is to strengthen the administrative infrastructure of the CRC and diversify the range of clinical research activities in the CRC by developing initiatives in oral health, community health, clinical pharmacology, and a collaborative clinical research network. A Core MT will be assembled to improve the management of CRC resources, CRC finances, clinical trials, report preparation, and stakeholder communication. The Associate Director for Oral Health Research will develop initiatives to expand the utilization of the CRC by the School of Dentistry and increase the number of clinical research studies in the area of oral health disparities. The RSA will ensure that research subject safety is accorded the highest priority. The Clinical Research Advisory Committee (CRAC) and External Advisory Committee (EAC) involvement in CRC development and evaluation will be strengthened. A CRC website and other tools for marketing the CRC and communicating with potential clinical investigators will be developed. Initiatives will also be developed to increase the number of clinical research studies in the areas of health disparity research including cancer, cardiovascular, infectious disease, HIV/AIDS, neurological/behavioral, and infant mortality. The MT will develop relationships with community health centers to expand CRC activities in population-based, patient-oriented research, and community outreach. The MT will participate in the planning and implementation of a Clinical Research Network in conjunction with other RCRII CRCs. A plan for expanding the capacity for clinical pharmacology research will be developed that will include pharmacokinetics, pharmacodynamics, and pharmacogenomics, and a clinical pharmacologist will be hired in year 03. These initiatives will correct the major weaknesses identified by the EAC, will move the CRC towards the long-term objective of General Clinical Research Center (GCRC) status, and ensure that it becomes a national resource for clinical research targeting health disparities.
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