How to Carry out Clinical Trials in Investigational Sites during COVID-19 Outbreak: A Single-Center Qualitative Study and System Review

Abstract

Objectives: This article offers general advice on how to conduct clinical trials during a disease pandemic by summarizing the difficulties and risks of clinical trials confronting investigational sites during the outbreak of COVID-19 and the responses taken throughout the country during the pandemic so as to give references to performing clinical trials in a safe and effective manner during COVID-19 outbreak or the potential disease outbreak in the future.

Methods: The systematic literature search was performed in Cochrane Library, MEDLINE, Baidu Search Engine, Google, and WeChat official Accounts platform. Studies published up to March 9, 2020 were searched. A pre-test for the title and abstract screening was performed by three reviewers.

Results: A total of 468 records were identified through online searching. As there were few studies about carrying out clinical trials in investigational sites as of March 9, 2020, after duplicate removal only 299 records were retrieved. 263 records were assessed for eligibility after title screening of which 15 records provided a clear description of clinical trials in investigational sites during COVID-19 outbreak published up to March 9, 2020.

Conclusion: Considering the summary of difficulties and risks arising from investigational sites and health institutions conducting clinical trials and the induction of relevant strategies and measures under the outbreak of COVID-19, following suggestions on pandemic are made accordingly based on informed analysis. First, hierarchical classification assessment of clinical trials is the top priority for conducting clinical trials under the pandemic. Second, conducting clinical trials in the way of non-contact is a necessary measure to ensure the safety of during the pandemic. Third, enhanced qualitative risk analysis of clinical trials and strict quality control are important means to ensure the integrity and authenticity of clinical trial data during pandemic.

Note: Funding: None.

Conflict of Interest: None.

Ethical Approval: This retrospective study was approved by the authors institute.