AASK COHORT STUDY

描述(由申请人提供)： MMC临床研究中心(CRC)的目标是支持临床研究，以改善非裔美国人和其他健康差距人群的健康，并增加全国从事临床研究的少数族裔医生和牙医队伍。具体目标是：1)加强临床研究中心的行政基础设施，并通过发展口腔健康、社区健康、临床药理学和协作临床研究网络方面的举措，使该中心的临床研究活动多样化；2)增加初级和有经验的临床研究人员可获得的直接研究支持的类型和质量；以及3)增加使用该中心进行临床研究的内科和牙科教员的人数。目标1是加强和扩大CRC，将通过建立一个核心管理团队(MT)来实现这一目标，以改善资源利用、财务管理、为临床试验的研究人员提供协助，并及时编写管理报告。口腔健康差距研究副主任将领导增加牙科教师的临床研究。研究课题倡导者(RSA)将确保研究对象的安全得到最高优先考虑。为了使临床研究多样化，CRC将与社区卫生中心和其他RCR11临床研究中心开展合作研究，以及临床药理学计划。目标2将增加直接研究支助的类型和质量，这将通过雇用一名具有临床试验经验的生物统计学家/流行病学家和一名数据分析员来实现，以满足越来越多的临床研究设计、研究方法、数据管理和手稿准备方面的援助要求。将增加两名研究助理，一名双语研究护士和一名社区实地研究护士，以改善患者招聘和社区推广，并适应不断增加的研究人员数量和临床研究活动的类型。在2002年，将聘请一名生物信息学经理开发和整合计算工具，以促进多学科临床研究。在二零零三年，我们会聘请一名临床药剂师，负责在中心内进行临床药理学研究。目标3涉及增加医学和牙科领域MMC临床研究人员数量的战略，包括短期“种子”资金以刺激研究人员发起的研究项目，以及为教师开发的临床研究项目提供长期资金，这些项目有可能成为校外资金。其他教师发展活动包括：1)每月举办CRC临床科学研讨会；2)跨学科临床研究研讨会；3)关于健康差距研究的年度研讨会；4)助学金研讨会；以及5)针对教员、住院医生和学生的临床研究课程。有了这些改进，CRC将在扩大学院临床研究方面发挥领导作用，并将成为针对健康差异的临床研究的全国专业知识来源。 儿童研究中心行政核心负责领导、管理儿童研究中心的日常运作、招聘新员工，以及制订和实施各项措施，以加强医疗中心的临床研究。具体目标1是加强儿童权利中心的行政基础设施，并通过在口腔健康、社区健康、临床药理学和协作临床研究网络方面的举措，使儿童权利中心的临床研究活动范围多样化。将组建一个核心MT，以改善对CRC资源、CRC资金、临床试验、报告准备和利益相关者沟通的管理。口腔健康研究副主任将制定倡议，以扩大牙科学院对儿童权利中心的利用，并增加口腔健康差距领域的临床研究数量。RSA将确保将研究对象的安全放在最优先的位置。将加强临床研究咨询委员会(CRAC)和外部咨询委员会(EAC)对CRC发展和评估的参与。将开发CRC网站和其他工具，用于推销CRC并与潜在的临床研究人员进行沟通。还将制定倡议，以增加健康差距研究领域的临床研究数量，包括癌症、心血管疾病、传染病、艾滋病毒/艾滋病、神经/行为和婴儿死亡率。MT将发展与社区卫生中心的关系，以扩大儿童权利中心在以人口为基础、以患者为导向的研究和社区推广方面的活动。MT将与其他RCRII CRC一起参与临床研究网络的规划和实施。将制定一项扩大临床药理学研究能力的计划，其中将包括药代动力学、药效学和药物基因组学，并将在03年聘请一名临床药理学家。这些举措将纠正选管会发现的主要弱点，推动临床研究中心(CRC)迈向综合临床研究中心(GCRC)的长期目标，并确保其成为针对健康差距的全国临床研究资源。

DESCRIPTION (provided by applicant): 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.