Methods in Clinical Cancer Research Workshop

临床癌症研究方法研讨会

• 批准号: 10721362
• 负责人: MANUEL HIDALGO
• 金额: $ 7万
• 依托单位: AMERICAN ASSOCIATION FOR CANCER RESEARCH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10721362
• 关键词: Acceleration; Address; American Association of Cancer Research; American Society of Clinical Oncology; Area; Basic Science; Cancer Patient; Career Choice; Caring; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Conduct Clinical Trials; Consent Forms; Contracts; Data; Data Reporting; Development; Discipline; Educational workshop; Effectiveness; Ensure; Ethnic Origin; Evaluation; Faculty; Feedback; Fostering; Funding; Future; Gender; Geography; Goals; Grant; Home; Immunologics; Individual; Institution; Institutional Review Boards; International; Knowledge; Malignant Neoplasms; Mentors; Mentorship; Methodology; Methods; National Cancer Institute; New Agents; Oncology; Participant; Patient Recruitments; Patient Self-Report; Patients; Phase; Positioning Attribute; Prevention; Preventive; Procedures; Process; Program Effectiveness; Protocols documentation; Public Health; Publications; Published Comment; Research Personnel; Review Literature; Site; Speed; Student Selections; Students; Surveys; Teaching Method; Technology; Testing; Training; Translational Research; Work; anticancer research; cancer clinical trial; cancer therapy; career; career development; career networking; clinical practice; clinical trial readiness; data mining; design; effectiveness evaluation; evaluation/testing; experience; falls; flexibility; follow-up; improved; lectures; member; novel therapeutics; patient oriented research; peer; phase 2 designs; phase II trial; pre-clinical; prevent; programs; protocol development; recruit; sound; student participation; success; targeted treatment; tool; trial design

Project Summary/Abstract The Methods in Clinical Cancer Research Workshop is a week-long program designed to educate and train early-career investigators in the best practices of clinical trial design, provide access to experienced clinical investigators from different institutions with expertise across all areas of clinical research, and develop and foster both peer-to-peer and mentoring relationships to enhance career development beyond the dates of the Workshop. Students are selected using a competitive application process that consists of a protocol concept, personal statement, and support from an existing mentor. Those accepted to the Workshop will have access to dozens of faculty members who, through the course of the Workshop, will help students develop concept sheets into IRB-ready clinical trials, including informed consent documents, ready for submission at their home institutions. Students participate in pre- and post-tests to determine the effectiveness of the program, which features a mix of didactic lectures, small group discussions, one-on-one mentoring sessions, and daily protocol development group sessions. The protocol development group sessions are made up of 3-4 faculty members and 8-10 students that work collaboratively as a group for the week. This makes up the core of the Workshop as the groups meet daily to review progress made each day and provide feedback and guidance for next steps in their individual trial designs. Daily, progressive assignments are submitted each evening, with reviews and comments from the faculty provided the following morning. The Workshop is offered to early-career investigators in all oncology disciplines who are nearing completion of their training or have recently begun their initial faculty positions. A review of the literature, comments from Workshop attendees, and the number of similar programs being developed in the U.S. and internationally shows that, despite advances in basic science and new preclinical agent development, there is a serious shortage of clinical investigators who have the pre-requisite knowledge to actually design and conduct effective clinical trials to match the attributes of these new agents. With the ever-increasing pace of technology and its implications in clinical trial design, the knowledge and number of tools that a clinical investigator needs to be able to utilize effectively continue to grow at a rapid rate. The Workshop is designed to address the needs today, while maintaining flexibility to implement changes to train early-career investigators on how to conduct effective clinical trials in the future. The Workshop is organized by the American Association for Cancer Research and the American Society of Clinical Oncology and has provided training to over 1800 investigators since its’ inception in 1996. The Workshop is evaluated through the use of pre- and post-tests given to the students; daily and week-long evaluations completed onsite; a 1-year, 3-year, 5-year, and 10-year followup survey each fall. The Workshop also contracted with an independent data-mining and analysis firm in 2013-2014 to provide a long-term historical comparison of students and non-students (applicants that were not accepted) that quantified their effectiveness pre- and post-Workshop in the areas of successful clinical trials, publications, grants, and collaborations.

项目概要/摘要 临床癌症研究方法研讨会是一个为期一周的项目，旨在 教育和培训早期职业研究者临床试验设计的最佳实践，提供 接触来自不同机构的经验丰富的临床研究人员，他们拥有各方面的专业知识 临床研究领域，并发展和培养同行和指导关系 加强研讨会日期之后的职业发展。 竞争性申请流程，包括协议概念、个人陈述和 接受研讨会的人将有机会获得数十名导师的支持。 通过研讨会课程帮助学生发展概念的教师 进入 IRB 就绪临床试验，包括知情同意文件，准备好 在其所在机构提交。 学生参加事前和事后测试以确定该计划的有效性，这 包括教学讲座、小组讨论、一对一辅导课程、 以及每日协议开发小组会议。 由 3-4 名教师和 8-10 名学生组成，他们作为一个小组协作工作 这构成了研讨会的核心，因为小组每天都会开会审查进展情况。 每天制作并为个人试验的后续步骤提供反馈和指导 每日、渐进的作业每天晚上提交，并附有评论和说明。 第二天早上，教师们发表了评论。 该研讨会面向所有肿瘤学学科的早期职业研究人员，他们即将 完成培训或最近开始担任初始教师职位的审查。 文献、研讨会参加者的评论以及类似项目的数量 美国和国际上的发展表明，尽管基础科学和技术取得了进步 新的临床前药物开发，临床研究人员严重短缺 实际设计和进行有效的临床试验以匹配的先决知识 随着技术及其影响的不断加快，这些新药物的属性。 在临床试验设计中，临床研究者需要具备的知识和工具数量 能够有效地利用持续快速增长的研讨会旨在解决。 当今的需求，同时保持灵活性以实施变革以培训早期职业生涯 研究者们就如何在未来进行有效的临床试验举办了研讨会。 由美国癌症研究协会和美国临床学会 自 1996 年成立以来，已为 1800 多名研究人员提供了肿瘤学培训。 研讨会通过每天对学生进行的事前测试和事后测试进行评估； 现场完成为期一周的评估；1年、3年、5年和10年的随访； 该研讨会还与独立的数据挖掘和分析机构签订了合同。 公司在2013-2014年提供学生和非学生的长期历史比较 （未被接受的申请人）量化了研讨会前后的有效性 成功的临床试验、出版物、资助和合作领域。

项目成果

Comparison of young clinical investigators' accuracy and reproducibility when measuring pulmonary and skin surface nodules using a circumferential measurement versus a standard caliper measurement: American Association for Cancer Research/American Society

年轻临床研究人员使用圆周测量与标准卡尺测量测量肺部和皮肤表面结节时的准确性和再现性的比较：美国癌症研究协会/美国协会

• 发表时间: 2000-01
• 作者: Monsky, W L;Heddens, D K;Clark, G M;Von Hoff, D D;Coltman Jr, C A;Dorr, R T;Alberts, D S
• 通讯作者: Alberts, D S

A Grant-Based Experiment to Train Clinical Investigators: The AACR/ASCO Methods in Clinical Cancer Research Workshop.

培训临床研究人员的基于拨款的实验：临床癌症研究研讨会中的 AACR/ASCO 方法。

• 发表时间: 2021
• 作者: Von Hoff, Daniel D;Clark, Gary M;Coltman, Charles A;Disis, Mary L;Eckhardt, S G;Ellis, Lee M;Foti, Margaret;Garrett;Gönen, Mithat;Hidalgo, Manuel;Hilsenbeck, Susan G;Littlefield, John H;LoRusso, Patricia M;Lyerly, H Kim;Mero
• 通讯作者: Mero