Yeboa Debra Nana, Akinfenwa Chidinma Anakwenze, Nguyen Jonathan, Amaya Diana, de Gracia Beth, Ning Matthew, Cox Victoria, De Brian, Smith Benjamin D, Lin Lili, Beddar Sam, Hoang Hanh, Koong Albert, Liao Zhongxing
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Adv Radiat Oncol. 2021 May-Jun;6(3):100676. doi: 10.1016/j.adro.2021.100676. Epub 2021 Mar 3.
Clinical trial enrollment has declined globally as a result of the coronavirus disease 2019 (COVID-19) pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently.
We report the effect of a phased trial reopening strategy, remote research staffing, and telemedicine on cancer trial enrollment at one of the largest radiation oncology academic cancer centers. In phase 1, trials investigating definitive therapeutic benefit were opened, followed by trials not increasing patient exposure or pulmonary toxicity risk in phase 2. During phase 2.5, multicenter trials reopened and limited research staff were allowed on site.
Despite initial enrollment declines during the early pandemic, the percentage of new patients enrolling in clinical trials from March to August 2020 was 8.8%, and represented a 10.5% relative increase from 2019. Monthly accrual enrollment from March to August 2019 ranged from 42 to 71, compared with enrollment during COVID-19 from 23 to 73 patients ( < .001).
Through a phased approach to trial reopening and adaptive techniques, the division of radiation oncology maintained cancer trial accrual during the COVID-19 pandemic. The experience may help centers maintain accrual, preserve clinical trial integrity, and minimize risk to patients and staff.
2019年冠状病毒病（COVID-19）大流行导致全球临床试验入组人数下降。这凸显了采用结构化方法以安全、高效地继续开展关键医学研究的重要性。
我们报告了一项分阶段试验重新开放策略、远程研究人员配备和远程医疗对一家最大的放射肿瘤学学术癌症中心癌症试验入组情况的影响。在第1阶段，开启了研究确定性治疗益处的试验，随后在第2阶段开启了不会增加患者暴露或肺部毒性风险的试验。在第2.5阶段，多中心试验重新开放，并允许有限的研究人员到现场。
尽管在疫情早期入组人数最初有所下降，但2020年3月至8月参加临床试验的新患者比例为8.8%，与2019年相比相对增加了10.5%。2019年3月至8月的每月累积入组人数在42至71人之间，而在COVID-19期间的入组人数为23至73人（P<0.001）。
通过分阶段试验重新开放方法和适应性技术，放射肿瘤学部在COVID-19大流行期间维持了癌症试验的入组。该经验可能有助于各中心维持入组、保持临床试验的完整性，并将对患者和工作人员的风险降至最低。
