杂志文章@ 2369-1999 I JMIR出版物创建和实施一个主要研卡塔尔世界杯8强波胆分析究者工具包,以提高后期临床试验的应计率:开发和可用性研究Higgins,Kristin A Thomas,Alexandra A Soto,Nancy Paulus,Rebecca A George,Thomas J %A Julian,Thomas B %A Hartson Stine,Sharon A Markham,Merry Jennifer,Maria + Winship癌症研究所,Emory大学,克利夫顿路东北1365 C,佐治亚州亚特兰大,30322,美国,1 (404)778 0603,kristin.higgins@emory.edu %K临床试验收益%K社交媒体工具%K首席研究员%K PI工具包%K肿瘤%K临床试验%K工具%K资源%K患者%K研究员%K收益%K开发%K参与%K研究%K社区%K计划%K激活%K社交媒体%D 2022 %7 25.8.2022 %9原始论文%J JMIR癌症%G英语%X背景:肿瘤临床试验收益仍然是一个挑战,特别是在COVID-19大流行期间。对于由国家癌症研究所资助的晚期临床试验,这些研究方案的开发是一个资源密集型的过程;然而,在整个国家临床试验网络(NCTN)中,优化试验启动后患者收益的机制还不发达。患者收益低可能导致临床试验过早结束,并最终推迟新的、可能挽救生命的肿瘤学疗法的可用性。目的:本研究的目的是为NCTN,特别是NRG肿瘤合作小组内的肿瘤临床试验研究人员正式创建一个易于实施的资源工具包,以优化患者收益。方法:NRG肿瘤学寻求正式开发一个资源工具包,在NRG肿瘤学临床试验生命周期的特定时间点使用。这些工具被清楚地描述,并涉及在计划、启动和应计期间促进研究首席研究员与科学和患者倡导团体的参与。社交媒体工具也被用来提高这种参与度。 The principal investigator (PI) tool kit was created in 2019 and thereafter piloted with the NRG Oncology/Alliance NRG-LU005 phase II or III trial in small-cell lung cancer. The PI tool kit was developed by the NRG Oncology Protocol Operations Management committee and was tested with the NRG/Alliance LU005 randomized trial within the NCTN. Results: NRG Oncology/Alliance NRG-LU005 has seen robust enrollment, currently 127% of the projected accrual. Importantly, many of the tool kit elements are already being used in ongoing NRG Oncology trials, with 56% of active NRG trials using at least one element of the PI tool kit and all in-development trials offered the resource. This underscores the feasibility and potential benefits of deploying the PI tool kit across all NRG Oncology trials moving forward. Conclusions: While clinical trial accrual can be challenging, the PI tool kit has been shown to augment accrual in a low-cost and easily implementable fashion. It could be widely and consistently deployed across the NCTN to improve accrual in oncology clinical trials. Trial Registration: ClinicalTrials.gov NCT03811002; https://clinicaltrials.gov/ct2/show/NCT03811002 %M 36006678 %R 10.2196/38514 %U https://cancer.www.mybigtv.com/2022/3/e38514 %U https://doi.org/10.2196/38514 %U http://www.ncbi.nlm.nih.gov/pubmed/36006678
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