The SARS-CoV-2 Pandemic and Cancer Trials Ireland: Impact, Resolution and Legacy.
The SARS-CoV-2 Pandemic and Cancer Trials Ireland: Impact, Resolution and Legacy.
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SARS-CoV-2大流行导致医疗保健严重中断。爱尔兰癌症试验是爱尔兰的国家合作癌症试验组织。我们分析了2年期间大流行对癌症临床试验的影响。临床试验应计额下降了54%，其中放疗试验受影响最大，下降了90%。减少的原因是工作人员减少、试验后勤延误以及出于安全考虑停止应计和启动。增加了对试验的远程监测。由于中断访问和诊断测试，违反协议的情况有所增加。对应计收益的影响持续了至少18个月。在征聘和留用方面明显存在重大的中央办事处员额问题。进行了一次撤退，以确定在临床试验行为中建立弹性所需的变革。试验行为中的适应性战略，如扩大远程保健和远程监测、试验安排的灵活性、受保护的工作人员分配以及对研究人员的指导，被确定为大流行病恢复阶段的优先事项。背景：爱尔兰癌症试验（CTI）是爱尔兰的国家合作组织。从2020年3月至今，SARS-CoV-2大流行导致了医疗保健领域持续发生的重大颠覆性变化。它对国家临床试验组织的影响和遗产进行了评估。方法：对2019年至2021年9月期间预期获得的通信、团队日志和时间表、试验启动、结束和应计进行了审查。对大流行对临床研究人员和临床试验单位的影响进行了在线调查。2021年5月21日组织了一次全国癌症务静会，以确定和应对与大流行有关的破坏，并制定适应战略。结果：在宣布大流行后的几周内，所有中央办公室工作人员都开始远程工作。在全国范围内，与2019年同期相比，临床试验应计额下降了54%，放疗试验应计额下降了90%，转化研究下降了36%。60%的单位重新分配了研究护士，42%的单位减少了试验监测，试验启动率下降了67%。在采取封锁措施的同时，监测时间也出现了极端波动。注意到对所有临床试验单位的重大影响，包括工作人员调动、获得诊断成像的机会减少和机构支助减少。远程诊疗和远程监护被广泛采用。国家癌症静养中心确定了试验实施的灵活性、工作人员的招聘和保留、流程协调的必要性以及远程工作背景下研究人员的支持等方面的优先事项。结论：大流行对爱尔兰的癌症临床试验活动产生了重大的持续负面影响。适应性战略，包括试验灵活性、扩大远程保健和远程监测、流程协调和工作人员支持，已被确定为减轻这种影响和发展更可持续的临床试验生态系统的优先事项。
The SARS-CoV-2 pandemic led to a significant disruption to healthcare. Cancer Trials Ireland is the national cooperative cancer trials organisation in Ireland. We analysed the impact of the pandemic on the conduct of cancer clinical trials over a 2 year period. Clinical trial accrual fell by 54%, with trials in radiotherapy being most affected, declining by 90%. This reduction was due to reduced staffing, delays in trial logistics and halting of accrual and initiations due to safety concerns. Remote monitoring of trials increased. Protocol violations increased due to interruption of visits and diagnostic testing. The impact on accrual persisted for at least 18 months. Significant central office staffing issues were evident with recruitment and retention. A retreat was conducted to identify the transformative changes that were needed to build resilience in clinical trial conduct. Adaptive strategies in trial conduct such as expanded telehealth and tele-monitoring, flexibility of trial scheduling, protected staff assignments, and mentoring of research staff were identified as priorities for the recovery stage of the pandemic. Background: Cancer Trials Ireland (CTI) is the national cooperative group in Ireland. The SARS-CoV-2 pandemic led to significant ongoing disruptive change in healthcare from March 2020 to the present day. Its impact and legacy on a national clinical trials organisation was assessed. Methods: A review was conducted of prospectively acquired communications, team logs and time sheets, trial activation, closure and accrual, for the period 2019 to September 2021. An online survey of the impact of the pandemic on clinical investigators and of clinical trials units was performed. A National Cancer Retreat was organised on 21 May 2021 to identify and address pandemic related disruption and develop adaptive strategies. Results: In the weeks after the pandemic was declared, remote working was initiated by all central office staff. Nationally, clinical trial accrual fell by 54% compared to the same period in 2019, radiotherapy trial accrual by 90%, and translational studies by 36%. Staff reassignment of research nurse staff occurred in 60% of units, trial monitoring was reduced in 42%, and trial initiations fell by 67%. Extreme fluctuations in monitoring hours were noted paralleling lockdown measures. Significant impact on all clinical trials units was noted including staff reassignments, reduced access to diagnostic imaging and reduced institutional supports. Remote clinic visits and remote monitoring was widely adopted. The National Cancer Retreat identified flexibility in trial conduct, staff recruitment and retention, the need for harmonisation of processes, and research staff support in the context of remote working as priorities. Conclusion: The pandemic has had a significant ongoing negative impact on cancer clinical trial activity in Ireland. Adaptive strategies including trial flexibility, expanded telehealth and remote monitoring, harmonisation of processes and staff support have been identified as priorities to ameliorate this impact, and develop a more sustainable clinical trial ecosystem.
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影响因子：
4.5
作者：
Lara Gongora AB;Werutsky G;Jardim DL;Nogueira-Rodrigues A;Barrios CH;Mathias C;Maluf F;Riechelmann R;Fraga M;Gomes H;William WN;Yamada CAF;de Castro G Jr;Rosa DD;de Melo AC;Sala R;Bustamante E;Bretel D;Arrieta O;Cardona AF;Bastos DA
通讯作者：
Bastos DA
DOI：
10.6004/jnccn.2020.7643
发表时间：
2021-05
期刊：
Journal of the National Comprehensive Cancer Network : JNCCN
影响因子：
--
作者：
Gerber DE;Sheffield TY;Beg MS;Williams EL;Clark VL;Xie Y;Holbein MEB;Skinner CS;Lee SJC
通讯作者：
Lee SJC
影响因子：
2.1
作者：
Farooq AR;Iqbal S;Abdulaziz N;O'Brien T;Peters N;Collins DC
通讯作者：
Collins DC
影响因子：
5.8
作者：
Clark, Serena;McGrane, Amy;O' Sullivan, Katriona
通讯作者：
O' Sullivan, Katriona
通过对爱尔兰的Covid-19的政策制定来建立卫生系统的韧性：从震惊到改革。
DOI：
10.1016/j.lanepe.2021.100223
发表时间：
2021-10
期刊：
The Lancet regional health. Europe
影响因子：
--
作者：
Burke S;Parker S;Fleming P;Barry S;Thomas S
通讯作者：
Thomas S