key: cord-0711082-z2j9snb6
authors: Su, Zheng; Wang, Sue-Jane
title: Guest editors-in-chief note to COVID-19 special issue
date: 2020-12-17
journal: Contemp Clin Trials
DOI: 10.1016/j.cct.2020.106241
sha: ee43854d81571f9fb0799cd5c6257da42d102c66
doc_id: 711082
cord_uid: z2j9snb6

nan

Available online 17 December 2020 1551-7144/© 2020 Elsevier Inc. All rights reserved.

Guest editors-in-chief note to COVID-19 special issue

The World Health Organization (WHO) declared COVID-19 a pandemic on March 11, 2020. This major public health emergency poses significant challenges to the conduct and analysis of ongoing clinical trials, which may need to be adapted for participant safety while maintaining the quality of the data and the interpretability of the results. Researchers across the globe have been actively conducting clinical trials in the pursuit of safe and effective treatments and vaccines for COVID-19. The antiviral drug remdesivir recently became the first approved treatment by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, and several COVID-19 vaccine candidates are on the cusp of producing results from their ongoing trials. As global infections of the novel coronavirus approach 50 million, more work urgently needs to be done to expedite the development of treatments and vaccines for COVID-19 and tackle the challenges posed to ongoing and future clinical trials being conducted across the globe. Recent announcements that three COVID-19 trials (one therapeutic development trial and two vaccine development trials) have been paused due to safety concerns remind us of the critical role the Data and Safety Monitoring Board (DSMB) plays in protecting patient safety [1] .

The papers in this COVID-19 special issue cover a range of topics, including mathematical modeling on the containment of COVID-19 with real-life experience in Taiwan [2] ; semi-parametric Bayesian inference on transmission dynamics of COVID-19 [3] ; a pragmatic clusterrandomized trial design for evaluating the effect of vitamin D on COVID-19 [4] ; use of causal inference methods for small nonrandomized studies with application to COVID-19 [5] ; appropriate primary endpoint selection for assessment of treatment effects in comparative clinical studies for COViD-19 [6] ; the role of the DSMB in evaluating treatments of COVID-19 [7] ; arguments against hastily deviating from original statistical analysis plans because of COVID-19 [8] ; a European perspective on infectious disease epidemiology, quantitative methodology and clinical research in the midst of the pandemic [9] ; and a U.S. perspective regarding COVID-19's impact on biostatistics and epidemiology [10] .

Challenging times call for innovative measures. We organized this special issue on COVID-19 to share innovative thinking on tackling some of the challenges the global clinical trials community continues to face during this pandemic. More importantly, we hope that the work contained in this issue will spur broader discussions and timely sharing of innovative ideas on COVID-19 among our readers. The Journal strives to provide a platform for timely knowledge exchange among experts in the global clinical trials community to address the most pressing issues that arise in today's dynamic healthcare environment.

We thank experts from around the globe-including statistical methodologists, clinical trialists, data safety monitoring committee members, epidemiologists, and infectious disease specialists-for their important contributions to this special issue.

Covid Trials Have Been Paused for Safety. That's a Good Thing

The Effect of Preventing Subclinical Transmission on the Containment of COVID-19: Mathematical Modeling and Experience in Taiwan

Semiparametric Bayesian Inference for the Transmission Dynamics of COVID-19 With a State-space Model

The Vitamin D for COVID-19 (VIVID) Trial: A Pragmatic Cluster-randomized Design

Causal inference methods for small non-randomized studies: methods and an application in COVID-19

Selecting Appropriate Endpoints for Assessing Treatment Effects in Comparative Clinical Studies for COVID-19

Data Monitoring Committee for Clinical Trials Evaluating Treatments of COVID-19

COVID-19 Hits a Trial: Arguments Against Hastily Deviating From the Plan

Infectious Disease Epidemiology, Quantitative Methodology, and Clinical Research in the Midst of the COVID-19 Pandemic: Perspective From a European Country

Reacting to Crises: The COVID-19 Impact on Biostatistics and Epidemiology