Managing Clinical Trials for Alzheimer's Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain.
Managing Clinical Trials for Alzheimer's Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain.
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DOI：
10.3233/jad-200750
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
Research Center and Memory Clinic, Fundació ACE
中科院分区：
文献类型：
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作者：
Abdelnour C;Esteban de Antonio E;Pérez-Cordón A;Lafuente A;Buendía M;Pancho A;Jofresa S;Aguilera N;Ibarria M;Cuevas R;Cañada L;Calvet A;Diego S;González-Pérez A;Orellana A;Montrreal L;de Jorge L;Marquié M;Benaque A;Gurruchaga M;Tárraga L;Ruiz A;Boada M;Research Center and Memory Clinic, Fundació ACE
COVID-19大流行给全球卫生系统带来了巨大破坏。这影响了正在进行的临床研究，特别是在那些最容易受到流行病影响的人中，如痴呆症患者。ACE基金会是一个研究中心和记忆诊所，总部设在西班牙巴塞罗那，这是受影响最严重的国家之一。介绍为科普这场危机而制定的特别战略计划，并分享其成果。我们描述了参与者的临床和人口统计学特征。此外，我们还解释了我们的战略计划，旨在最大限度地减少对临床试验研究活动的影响，其中包括对所有参与者和工作人员进行SARS-CoV-2 RT-PCR和IgG血清学检测。根据研究期间观察到的安全性事件和脱落情况描述计划结局。在封锁建立时，共有130名患者参加了ACE基金会的16项积极临床试验。在隔离期间，我们向参与者拨打了1018次电话，其中26次发现了不良事件，6次发现了COVID-19症状。共有83名患者（64%）可以在2020年5月11日重新开始现场访视。现场访视前进行的所有SARS-CoV-2 RT-PCR诊断检测均为阴性，只有3次IgG血清学检测为阳性。在整个研究期间，我们仅观察到一例因与COVID-19无关的不良事件而脱落的患者。ACE基金会实施的计划能够保护正在进行的临床试验的安全性和完整性。我们必须利用从大流行病中吸取的教训，为临床试验设计防危机的方案。
The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. We describe participants’ clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.