Shalini Moningi MD , Shane Stecklein MD, PhD , Sonal Noticewala MD, MAS , Olsi Gjyshi MD , Todd Pezzi MD , David Boyce-Fappiano MD , Prajnan Das MD, MS, MPH , Bruce Minsky MD , Emma B. Holliday MD , Andrew J. Bishop MD , Albert C. Koong MD, PhD , Chelsea C. Pinnix MD, PhD
{"title":"弗莱彻-考克斯途径：临床试验教育的独特视角","authors":"Shalini Moningi MD , Shane Stecklein MD, PhD , Sonal Noticewala MD, MAS , Olsi Gjyshi MD , Todd Pezzi MD , David Boyce-Fappiano MD , Prajnan Das MD, MS, MPH , Bruce Minsky MD , Emma B. Holliday MD , Andrew J. Bishop MD , Albert C. Koong MD, PhD , Chelsea C. Pinnix MD, PhD","doi":"10.1016/j.adro.2024.101637","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>There currently are no established formal mentorship and training programs for radiation oncology (RO) trainees to learn trial design, creation, writing, or implementation. There only exists informal training on analyzing clinical trials in RO residency programs. The integration of a longitudinal formal training and mentorship program for clinical trialists—consisting of clinical trial education, design, mentorship, and implementation during the RO residency education—will give residents not only formal teaching in the subject but also strong tools and requisite mentorship in hopes to help them succeed as future academic physicians and leaders in the field of RO.</div></div><div><h3>Methods and Materials</h3><div>We developed a clinical trial training pathway in 2018 at MD Anderson Cancer Center, proposing it as a pilot program. The “Fletcher-Cox Pathway” was accepted with a highly positive response by trainees and is now offered as a standard option to RO trainees at our institution.</div></div><div><h3>Results</h3><div>With the guidance of their principal investigator, residents participating in this pathway design and submit a clinical trial for institutional review board review. In 2019, after implementation of the pilot program, 4 of the incoming 7 residents joined the pathway. The program continues, and the current cohort of trainees have received training in clinical trial design and worked with dedicated mentor(s) regarding clinical trial ideas; their studies are currently accruing patients.</div></div><div><h3>Conclusions</h3><div>This pilot program has been viewed by trainees and mentors as successful; it highlights how a structured approach meets a clear need within RO training. We envision the creation of a national platform to increase access, whereby programs adopt this clinical trialist educational pathway, which ultimately leads to the development of a robust clinical trial community with communal resources. We hope that this not only improves and provides educational initiatives to all trainees but also initiates further collaboration.</div></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 12","pages":"Article 101637"},"PeriodicalIF":2.2000,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Fletcher-Cox Pathway: A Unique View on Clinical Trial Education\",\"authors\":\"Shalini Moningi MD , Shane Stecklein MD, PhD , Sonal Noticewala MD, MAS , Olsi Gjyshi MD , Todd Pezzi MD , David Boyce-Fappiano MD , Prajnan Das MD, MS, MPH , Bruce Minsky MD , Emma B. Holliday MD , Andrew J. Bishop MD , Albert C. Koong MD, PhD , Chelsea C. Pinnix MD, PhD\",\"doi\":\"10.1016/j.adro.2024.101637\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>There currently are no established formal mentorship and training programs for radiation oncology (RO) trainees to learn trial design, creation, writing, or implementation. There only exists informal training on analyzing clinical trials in RO residency programs. The integration of a longitudinal formal training and mentorship program for clinical trialists—consisting of clinical trial education, design, mentorship, and implementation during the RO residency education—will give residents not only formal teaching in the subject but also strong tools and requisite mentorship in hopes to help them succeed as future academic physicians and leaders in the field of RO.</div></div><div><h3>Methods and Materials</h3><div>We developed a clinical trial training pathway in 2018 at MD Anderson Cancer Center, proposing it as a pilot program. The “Fletcher-Cox Pathway” was accepted with a highly positive response by trainees and is now offered as a standard option to RO trainees at our institution.</div></div><div><h3>Results</h3><div>With the guidance of their principal investigator, residents participating in this pathway design and submit a clinical trial for institutional review board review. In 2019, after implementation of the pilot program, 4 of the incoming 7 residents joined the pathway. The program continues, and the current cohort of trainees have received training in clinical trial design and worked with dedicated mentor(s) regarding clinical trial ideas; their studies are currently accruing patients.</div></div><div><h3>Conclusions</h3><div>This pilot program has been viewed by trainees and mentors as successful; it highlights how a structured approach meets a clear need within RO training. We envision the creation of a national platform to increase access, whereby programs adopt this clinical trialist educational pathway, which ultimately leads to the development of a robust clinical trial community with communal resources. We hope that this not only improves and provides educational initiatives to all trainees but also initiates further collaboration.</div></div>\",\"PeriodicalId\":7390,\"journal\":{\"name\":\"Advances in Radiation Oncology\",\"volume\":\"9 12\",\"pages\":\"Article 101637\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-09-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Radiation Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2452109424002008\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Radiation Oncology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2452109424002008","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
The Fletcher-Cox Pathway: A Unique View on Clinical Trial Education
Purpose
There currently are no established formal mentorship and training programs for radiation oncology (RO) trainees to learn trial design, creation, writing, or implementation. There only exists informal training on analyzing clinical trials in RO residency programs. The integration of a longitudinal formal training and mentorship program for clinical trialists—consisting of clinical trial education, design, mentorship, and implementation during the RO residency education—will give residents not only formal teaching in the subject but also strong tools and requisite mentorship in hopes to help them succeed as future academic physicians and leaders in the field of RO.
Methods and Materials
We developed a clinical trial training pathway in 2018 at MD Anderson Cancer Center, proposing it as a pilot program. The “Fletcher-Cox Pathway” was accepted with a highly positive response by trainees and is now offered as a standard option to RO trainees at our institution.
Results
With the guidance of their principal investigator, residents participating in this pathway design and submit a clinical trial for institutional review board review. In 2019, after implementation of the pilot program, 4 of the incoming 7 residents joined the pathway. The program continues, and the current cohort of trainees have received training in clinical trial design and worked with dedicated mentor(s) regarding clinical trial ideas; their studies are currently accruing patients.
Conclusions
This pilot program has been viewed by trainees and mentors as successful; it highlights how a structured approach meets a clear need within RO training. We envision the creation of a national platform to increase access, whereby programs adopt this clinical trialist educational pathway, which ultimately leads to the development of a robust clinical trial community with communal resources. We hope that this not only improves and provides educational initiatives to all trainees but also initiates further collaboration.
期刊介绍：
The purpose of Advances is to provide information for clinicians who use radiation therapy by publishing: Clinical trial reports and reanalyses. Basic science original reports. Manuscripts examining health services research, comparative and cost effectiveness research, and systematic reviews. Case reports documenting unusual problems and solutions. High quality multi and single institutional series, as well as other novel retrospective hypothesis generating series. Timely critical reviews on important topics in radiation oncology, such as side effects. Articles reporting the natural history of disease and patterns of failure, particularly as they relate to treatment volume delineation. Articles on safety and quality in radiation therapy. Essays on clinical experience. Articles on practice transformation in radiation oncology, in particular: Aspects of health policy that may impact the future practice of radiation oncology. How information technology, such as data analytics and systems innovations, will change radiation oncology practice. Articles on imaging as they relate to radiation therapy treatment.
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