提高临床试验现场技能的框架：从临床试验协调员劳动力能力建设试点项目中获得的经验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-15 DOI:10.1016/j.conctc.2025.101460

Thobekile Mthethwa-Pitt , Prudence Perry , Jhodie Duncan , Felicity Osmond , Anne Woollett

{"title":"提高临床试验现场技能的框架：从临床试验协调员劳动力能力建设试点项目中获得的经验","authors":"Thobekile Mthethwa-Pitt , Prudence Perry , Jhodie Duncan , Felicity Osmond , Anne Woollett","doi":"10.1016/j.conctc.2025.101460","DOIUrl":null,"url":null,"abstract":"<div><h3>Aim</h3><div>This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity.</div></div><div><h3>Method</h3><div>The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development.</div></div><div><h3>Results</h3><div>Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites’ specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs.</div></div><div><h3>Conclusion</h3><div>Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101460"},"PeriodicalIF":1.4000,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A framework for upskilling the clinical trial site: Learnings from a clinical trial coordinator workforce capability building pilot program\",\"authors\":\"Thobekile Mthethwa-Pitt , Prudence Perry , Jhodie Duncan , Felicity Osmond , Anne Woollett\",\"doi\":\"10.1016/j.conctc.2025.101460\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Aim</h3><div>This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity.</div></div><div><h3>Method</h3><div>The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development.</div></div><div><h3>Results</h3><div>Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites’ specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs.</div></div><div><h3>Conclusion</h3><div>Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.</div></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"44 \",\"pages\":\"Article 101460\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-02-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865425000341\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865425000341","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

摘要

目的介绍一种针对从事临床试验的卫生服务机构的简单教育模式。临床试验协调员（ctc）对临床试验工作人员的运作至关重要；然而，他们在技能和知识方面存在着巨大的差距。TrialHub的技能提升试点项目是一项新颖的、多模式的技能提升计划，旨在开发一个创新的临床试验教育框架，在所有员工中建立一致的标准，而不考虑地点和成熟度。方法在临床试验成熟度不同的7家卫生服务机构实施技能提升试点项目。该项目采用了循序渐进的参与方式，并结合了指导、内部培训计划战略和持续的专业发展计划等要素。这种方法的指导方针是在个别卫生服务中心层面与卫生服务组织治理层面进行磋商，使教育项目能够由卫生服务中心的需求驱动，并监督每个站点的技能标准。跟踪现场活动参与会议，以绘制提升技能元素实施的进度，并告知框架开发。在30个月的时间里（2022年1月至2024年6月），现场参与度跟踪显示每个站点的不同需求，与不同的站点成熟度水平相一致，并在整个试点期间不断提高技能优先级和重点。这些见解强调了在开发过程中根据站点的具体情况和变化成熟度来裁剪技能元素和教育计划的需求。随后，在这些项目学习的基础上，建立了一个技能提升框架，以指导未来的劳动力发展和增长需求。尽管样本量有限，但该试点项目显示了一种量身定制的多模式技能提升方法的潜力，可以为临床试验协调提供宝贵的专业学习经验，并支持临床试验场地能力的发展。如CTC技能提升框架所述，临床试验场所采用技能提升项目需要通过适应性实施进行协调和结构化支持。如果要使临床试验场地足够成熟，并能够满足澳大利亚社区不断增长的需求，就需要在提高临床试验场地能力的同时提高ctc的技能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

A framework for upskilling the clinical trial site: Learnings from a clinical trial coordinator workforce capability building pilot program

Aim

This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity.

Method

The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development.

Results

Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites’ specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs.

Conclusion

Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.