[HTML][HTML] Digital health COVID-19 impact assessment: lessons learned and compelling needs

P Lee, A Abernethy, D Shaywitz, AV Gundlapalli… - NAM …, 2022 - ncbi.nlm.nih.gov
This discussion paper is part of the National Academy of Medicine's Emerging Stronger After
COVID-19: Priorities for Health System Transformation initiative, which commissioned …

Challenges and solutions in clinical research during the COVID‐19 pandemic: A narrative review

M Nomali, N Mehrdad, ME Heidari, A Ayati… - Health science …, 2023 - Wiley Online Library
Abstract Background and Aims The COVID‐19 pandemic has presented significant
challenges to clinical research, necessitating the adoption of innovative and remote …

Machine learning for clinical trials in the era of COVID-19

WR Zame, I Bica, C Shen, A Curth, HS Lee… - Statistics in …, 2020 - Taylor & Francis
The world is in the midst of a pandemic. We still know little about the disease COVID-19 or
about the virus (SARS-CoV-2) that causes it. We do not have a vaccine or a treatment (aside …

Clinical trials impacted by the COVID-19 pandemic: adaptive designs to the rescue?

CU Kunz, S Jörgens, F Bretz, N Stallard… - Statistics in …, 2020 - Taylor & Francis
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic …

[HTML][HTML] A qualitative study on the impacts of COVID-19 on the delivery of randomised controlled trials evaluating lay-delivered psychological interventions in five …

A Massazza, B Roberts, DC Fuhr, A Woodward… - SSM-Mental …, 2023 - Elsevier
COVID-19 is having substantial impacts on research conduct, including clinical trials.
However, there is limited research investigating the impact of the pandemic on the conduct …

Estimands and their estimators for clinical trials impacted by the COVID-19 pandemic: a report from the NISS Ingram Olkin Forum Series on unplanned clinical trial …

K Van Lancker, S Tarima, J Bartlett… - Statistics in …, 2023 - Taylor & Francis
The COVID-19 pandemic continues to affect the conduct of clinical trials globally.
Complications may arise from pandemic-related operational challenges such as site …

[HTML][HTML] Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder: Telemedicine for Evaluation, Adherence and Medication for …

AH Talal, M Markatou, EM Sofikitou, LS Brown… - Contemporary Clinical …, 2022 - Elsevier
Background Telemedicine has the potential to increase healthcare access especially for
vulnerable populations. Telemedicine for Evaluation, Adherence, and Medication for …

Why ITT analysis is not always the answer for estimating treatment effects in clinical trials

ON Keene, D Wright, A Phillips, M Wright - Contemporary Clinical Trials, 2021 - Elsevier
For many years there has been a consensus among the Clinical Research community that
ITT analysis represents the correct approach for the vast majority of trials. Recent worldwide …

Application of estimand framework in ICH E9 (R1) to safety evaluation

X Wang, P Yang, SS Yuan… - Journal of …, 2023 - Taylor & Francis
Defining the right question of interest is important to a clinical study. ICH E9 (R1) introduces
the framework of an estimand and its five attributes, which provide a basis for connecting …

Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic

JC Reid, A Molloy, G Strong, L Kelly, H O'Grady… - Trials, 2022 - Springer
Rationale The COVID-19 pandemic disrupted non-COVID critical care trials globally as
intensive care units (ICUs) prioritized patient care and COVID-specific research. The …