Nomali Mahin, Mehrdad Neda, Heidari Mohammad Eghbal, Ayati Aryan, Yadegar Amirhossein, Payab Moloud, Olyaeemanesh Alireza, Larijani Bagher
Department of Epidemiology and Biostatistics, School of Public Health Tehran University of Medical Sciences Tehran Iran.
Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute Tehran University of Medical Sciences Tehran Iran.
Health Sci Rep. 2023 Aug 6;6(8):e1482. doi: 10.1002/hsr2.1482. eCollection 2023 Aug.
The COVID-19 pandemic has presented significant challenges to clinical research, necessitating the adoption of innovative and remote methods to conduct studies. This study aimed to investigate these challenges and propose solutions for conducting clinical research during the pandemic.
A narrative review was conducted (approval ID: IR.AMS.REC.1401.029), utilizing keyword searches in PubMed and Web of Science (WOS) citation index expanded (SCI-EXPANDED) from January 2020 to January 2023. Keywords included COVID-19, clinical research, barriers, obstacles, facilitators and enablers.
Out of 2508 records retrieved, 43 studies were reviewed, providing valuable insights into the challenges and corresponding solutions for conducting clinical research during the COVID-19 pandemic. The identified challenges were categorized into four main groups: issues related to researchers or investigators, issues related to participants and ethical concerns, administrative issues, and issues related to research implementation. To address these challenges, multiple strategies were proposed, including remote monitoring through phone or video visits, online data collection and interviews to minimize in-person contact, development of virtual platforms for participant interaction and questionnaire completion, consideration of financial incentives, adherence to essential criteria such as inclusion and exclusion parameters, participant compensation, and risk assessment for vulnerable patients.
The COVID-19 pandemic has significantly impacted clinical research, requiring the adaptation and enhancement of existing research structures. Although remote methods and electronic equipment have limitations, they hold promise as effective solutions during this challenging period.
新冠疫情给临床研究带来了重大挑战,因此需要采用创新的远程方法来开展研究。本研究旨在调查这些挑战,并提出在疫情期间进行临床研究的解决方案。
进行了一项叙述性综述(批准号:IR.AMS.REC.1401.029),利用2020年1月至2023年1月在PubMed和科学网(WOS)核心合集(SCI-EXPANDED)中进行的关键词搜索。关键词包括新冠病毒、临床研究、障碍、阻碍因素、促进因素和推动因素。
在检索到的2508条记录中,对43项研究进行了综述,为新冠疫情期间进行临床研究的挑战及相应解决方案提供了有价值的见解。确定的挑战分为四大类:与研究人员或调查人员相关的问题、与参与者和伦理问题相关的问题、管理问题以及与研究实施相关的问题。为应对这些挑战,提出了多种策略,包括通过电话或视频访视进行远程监测、在线数据收集和访谈以尽量减少面对面接触、开发虚拟平台用于参与者互动和问卷填写、考虑经济激励措施、遵守纳入和排除标准等基本标准、参与者补偿以及对弱势患者进行风险评估。
新冠疫情对临床研究产生了重大影响,需要对现有的研究结构进行调整和完善。尽管远程方法和电子设备存在局限性,但在这一具有挑战性的时期,它们有望成为有效的解决方案。