TRAINING PROGRAM IN HUMAN INVESTIGATION

描述(申请人摘要) 临床研究人员正在从联邦资助的行列中消失 研究投资组合到了某种程度上，他们已经成为一种“濒危物种” 为了弥补这一损失，这项拟议的硕士课程的目标是 托马斯·杰斐逊大学准备让研究人员为持久的职业生涯做准备 追求资助的、假设驱动的、以患者为导向的研究，并成为 为追求相似职业的后续调查人员提供模特和导师。这 提案提出了一种由多学科组成的临床研究课程 在以病人为中心的研究方面具有专业知识的学科教员，扩大了 相关课程的现有核心内容和以患者为基础的研究经验；以及 临床调查辅导培训。圆满完成 建议的课程将需要超过40个学分和正式的 研究论文和答辩。申请最初将从一个 从不同学院抽调的大批受训人员((多于650人)) 在大学里。符合资格的申请者将包括房屋事务官员和 副专业研究员，牙医，药剂师，拥有药学博士和博士学位。 研究员，以及对病人感兴趣的护理博士学位的人- 以研究为导向。申请者将提交书面申请，三人 推荐信和成绩单，并将由咨询人员选择 委员会在个人面谈后。一旦被录取，实习生将继续 独特的教学和应用研究组件计划。正式的课程作业 将为以患者为中心的研究提供基本主题的培训 包括生物统计学、流行病学、临床试验设计、结果 研究、生物伦理学和负责任的研究、临床 药理学，关于人体的联邦政策和法规，以及科学 写作。课程作业将补充提供以下内容的组件 实践经验是进行以患者为中心的研究的核心。 这些将包括(1)#年在杰斐逊临床研究单位的助理职位 哪些学员将通过以下方式参与指导临床研究体验 生成、实施、完成和报告随机临床 试验；以及(2)确定特定兴趣的论文问题和 咨询，论文提案的开发，以及论文研究的进行。 这一培训计划的其他新颖方面包括轮换 机构评审委员会(IRB)和癌症临床研究评审委员会 (CCRRC)和科学文献批判性审查的助理职位 《内科医学年鉴》的编辑人员。其他重要事项 方案部分将包括道德研讨会和会议、期刊 临床研究俱乐部，一个内部研究研讨会系列，以及 举办临床研究研讨会，邀请外地讲者出席 机构。完成培训后，学员将拥有(1) 深入理解以病人为基础的假设的形成和检验 研究，(2)研究的理论基础和工作知识 设计，(3)洞察基于实验室的分析和 以患者为中心的研究中的替代终点，(4)已证明的记录 开展随机临床试验和其他类型研究的成就 通过出版进行记录，(5)批判性评估 科学文献，以及(6)使用各种基于计算机的 研究相关问题中的统计和数据库程序包。vt.在.的基础上 课程完成后，学员将有资格独立表演 通过人类理学硕士认证的临床研究 调查。

DESCRIPTION (Applicant's Abstract) Clinical investigators are disappearing from the ranks of federally funded research portfolios to the extent that they have become an "endangered species". To counter this loss, the goal of this proposed Master's program at Thomas Jefferson University is to prepare investigators for enduring careers pursuing funded, hypothesis-driven patient-oriented research and to be role models and mentors to subsequent investigators pursing similar careers. This proposal presents a Clinical Research Curriculum composed of a multi- disciplinary faculty with expertise in patient-oriented research, an expanded existing core of relevant courses and patient-based research experiences, and mentored training in clinical investigation. Successful completion of the proposed program will require greater than 40 course credits and a formal research thesis and defense. Applications initially will be solicited from a large pool ((greater than 650) of trainees drawn from the different colleges within the university. Eligible applicants will include house officers and subspeciality fellows, dentists, pharmacy fellows with a Pharm.D., Ph.D. fellows, and those with doctoral degree in nursing interested in patient- oriented research. Applicants will submit a written application, three letters of recommendation, and transcripts and will be selected by an Advisory Committee following personal interviews. Once accepted, trainees will pursue a unique program of didactic and applied research components. Formal coursework will provide training in essential topics for patient-oriented research including biostatistics, epidemiology, clinical trial design, outcomes research, bioethics and the responsible conduct of research, clinical pharmacology, federal policy and regulations on human subjects, and scientific writing. Coursework will be supplemented with components that provide practical experience central to the conduct of patient-oriented research. These will include (1) a clerkship in the Jefferson Clinical Research Unit in which trainees will participate in a mentored clinical research experience by generating, implementing, completing, and reporting on a randomized clinical trial; and (2) identification of an interest-specific thesis question and advisory, development of a thesis proposal, and conduct of thesis research. Additional novel aspects of this training program include rotations on the Institutional Review Board (IRB) and Cancer Clinical Research Review Committee (CCRRC) and a clerkship in the critical review of scientific literature with the editorial staff of the Annals of Internal Medicine. Other important programmatic components will include ethics seminars and conferences, journal club in clinical investigation, an in-house research seminar series, and seminars in clinical investigation with invited speakers from outside the institution. Upon completion of the program, trainees will have (1) a thorough understanding of hypothesis formulation and testing in patient-based studies, (2) a theoretical foundation and working knowledge of research designs, (3) insight into the integration of laboratory-based analyses and surrogate endpoints in patient-oriented research, (4) a demonstrated record of achievement conducting randomized clinical trials and other types of studies documented through publication, (5) the ability to critically evaluate the scientific literature, and (6) the ability to employ various computer-based statistical and database packages in research-related problems. Upon completion of the program, trainees will be qualified to perform independent clinical research with certification through a Master's of Science in Human Investigation.