MENTORED MEDICAL STUDENT CLINCAL RESEARCH PROGRM

描述(改编自申请人的摘要)：申请人的目标 对于MMSCRP来说，是为了获得对学术临床的深入接触 研究并开始获得从事病人职业生涯所需的技能- 以研究为导向。此外，被调查的具体项目将 允许申请人将严谨的科学方法应用于 对无反应的临床问题进行补充医学治疗 对传统疗法很有帮助。申请者将收到结构化 在研究的所有阶段进行指导，包括招募患者， 研究测试、数据组织、分析、解释和 演示文稿。申请人的教育计划将提供严格的 为期一年的课程，将包括成果研究和 临床流行病学，研究设计，生物统计学方法和分析， 临床试验的进行、临床试验中的伦理问题和健康 服务研究。除了正规的课程外，申请人还将 积极参与大学的礼仪审查和讨论 院校检讨委员会。最后，申请者将全面参与 定期安排的会议、会议和对议定书的审查 综合临床研究中心(GCRC)。这项临床研究将是一个 前瞻性、随机、双盲、安慰剂对照试验 如果一种草药制剂，Padma Basic，可以改善患者的功能 症状性PVOD治疗16周。研究的主要终点是 最大步行距离。次要终端将包括：1)无痛 步行距离；2)血流介导的内皮依赖性前臂血管扩张； 3)安静和运动后踝臂指数及动脉波形； 4)血压、血脂和凝血谱；5)患者情况良好- 生存状态与生活质量--SF-36功能自评 和行走障碍问卷。MMSCRP将为申请人提供 有机会将广泛的课堂和研讨会课程结合在一起 在一个由学生发起的项目的临床研究中，她 对临床研究的所有阶段都有直接经验 包括研究设计、数据采集、分析和陈述。它是 预计这将巩固在以下领域获得的信息和技能 之前的培训，将是以患者为基础的职业生涯的第一步 调查。

DESCRIPTION (Adapted from the applicant's abstract): The applicant's goals for this MMSCRP are to obtain an in-depth exposure to academic clinical research and to begin to acquire the skills necessary for a career in patient- oriented research. In addition, the specific project to be investigated will allow the applicant to apply rigorous scientific methods in the study of a complementary medical therapy for a clinical problem which does not respond well to conventional therapies. The applicant will receive structured mentoring at all stages of the study, including recruitment of patients, performance of study tests, data organization, analysis, interpretation, and presentation. The applicant's educational plan will provide rigorous coursework in a one-year program which will cover outcomes research and clinical epidemiology, study design, biostatistical methods and analysis, conduct of clinical trials, ethical issues in clinical trials, and health services research. In addition to formal coursework, the applicant will actively participate in protocol review and discussions in the University's Institutional Review Board. Finally, the applicant will fully participate in regularly scheduled conferences, meetings, and reviews of protocols in the General Clinical Research Center (GCRC). The clinical study will be a prospective, randomized, double-blind, placebo-controlled trial to determine if a herbal preparation, Padma Basic, improves function in patients with symptomatic PVOD treated for 16 weeks. The primary endpoint of the study is maximal walking distance. Secondary endpoints will include: 1) pain-free walking distance; 2) flow-mediated endothelium-dependent forearm vasodilation; 3) resting and post-exercise ankle/brachial indices and arterial waveforms; 4) blood pressure, serum lipid and coagulation profiles; and 5) patient well- being and quality of life self-assessment of function as determined by SF-36 and Walking Impairment Questionnaires. The MMSCRP would provide the applicant with the opportunity to combine an extensive classroom and seminar curriculum in clinical research with a project initiated by the student, in which she will have direct experience in all phases of the conduct of a clinical study including study design, data acquisition, analysis, and presentation. It is expected that this will consolidate information and skills acquired in previous training and will be the first step in a career in patient-based investigation.