MSKCC Clinical Research Methodology Curriculum

描述（由申请人提供）： 这一竞争性申请旨在更新纪念斯隆-凯特琳癌症中心（MSKCC）的教学临床研究方法课程（CRMC）。 来自麻醉学和重症监护，流行病学和生物统计学，医学，外科，放射肿瘤学，儿科，神经病学，泌尿学，精神病学和行为科学部门的教师将参加为期两年的多学科课程，该课程提供教学课程工作和作为独立临床研究人员成功职业所需的基本技能。 拟议的课程是从最初的应用程序的大幅增强和方案演变。 四个教学研究方法模块提供了全面和深入的指导方法和理论基础健全的临床研究。 它们包括：1）从临床前测试到FDA批准的研究药物和医疗器械开发; 2）结局分析、心理测量、生物标志物和流行病学的临床研究; 3）涉及人类受试者研究的道德行为、法规、数据管理、报告责任、机构监督和临床研究中的利益冲突; 4）临床试验设计、相关科学的整合、伦理考虑和监管监督。 该课程还包括生物统计学课程和高度互动的研讨会，包括赠款写作和临床方案制定，提供假设检验和临床试验方法的额外培训。 自成立以来，该计划已成功地实现了培训独立的临床研究人员在不同学科的目标，包括妇产科，骨科手术，耳鼻喉科，普通外科，泌尿外科，肿瘤学，儿科肿瘤学，神经病学，精神病学和行为科学，放射肿瘤学。 这些研究人员有学术预科和校外资助他们的临床研究的杰出记录，并发表了300多篇手稿。 通过本课程培训的独立临床研究者已经是生物医学研究的新兴领导者，为全国75个IRB批准的研究方案提供了主要或共同主要研究者的知识领导。 这一竞争性更新表明了我们对临床研究者培训的实质性承诺以及CRMC在实现这一目标方面的成功。

DESCRIPTION (provided by applicant): This competing application seeks to renew the didactic Clinical Research Methodology Curriculum (CRMC) at Memorial Sloan-Kettering Cancer Center (MSKCC). Faculty from the Departments of Anesthesiology and Critical Care, Epidemiology and Biostatistics, Medicine, Surgery, Radiation Oncology, Pediatrics, Neurology, Urology, Psychiatry and Behavioral Sciences will participate in a two-year, multidisciplinary program that provides the didactic course work and fundamental skills required for a successful career as an independent clinical researcher. The proposed curriculum represents a substantial enhancement and programmatic evolution from the initial application. Four didactic research methodology modules provide comprehensive and in-depth instruction in the methodology and theory fundamental to sound clinical research. They include: 1) Investigational drug and medical device development from pre-clinical testing to FDA approval; 2) Clinical research in outcomes analysis, psychometric measurements, biological markers, and epidemiology; 3) Ethical conduct, regulations involving human subject research, data management, reporting responsibilities, institutional oversight, and conflict of interest in clinical investigations; 4) Clinical trial designs, integration of correlative sciences, ethical considerations, and regulatory oversight. The curriculum also includes a course in biostatistics and highly interactive workshops in both grant writing and clinical protocol development that provide additional training in hypothesis testing and clinical trial methodology. Since its inception, the program has been successful in achieving its goal of training independent clinical researchers in diverse disciplines including Obstetrics and Gynecology, Orthopedic Surgery, Otolaryngology, General Surgery, Urology, Oncology, Pediatric Oncology, Neurology, Psychiatry and Behavioral Sciences, and Radiation Oncology. These investigators have outstanding records of academic matriculation and extramural funding for their clinical research and have published over 300 manuscripts. The independent clinical investigators trained by this curriculum are already emerging leaders in biomedical research, providing intellectual leadership as Principal or Co-Principal Investigators for 75 IRB-approved research protocols nationwide. This competitive renewal demonstrates our substantial commitment to the training of clinical investigators and the success of the CRMC in achieving that goal.