[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 …

Point estimation for adaptive trial designs I: A methodological review

DS Robertson, B Choodari‐Oskooei… - Statistics in …, 2023 - Wiley Online Library
Recent FDA guidance on adaptive clinical trial designs defines bias as “a systematic
tendency for the estimate of treatment effect to deviate from its true value,” and states that it is …

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 …

The impact of COVID‐19 on the initiation of clinical trials in Europe and the United States

F Lasch, EE Psarelli, R Herold… - Clinical …, 2022 - Wiley Online Library
The coronavirus disease 2019 (COVID‐19) pandemic has a major impact not only on public
health and daily living, but also on clinical trials worldwide. To investigate the potential …

Efficient adaptive designs for clinical trials of interventions for COVID-19

N Stallard, L Hampson, N Benda… - Statistics in …, 2020 - Taylor & Francis
The COVID-19 pandemic has led to an unprecedented response in terms of clinical
research activity. An important part of this research has been focused on randomized …

Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

M Akacha, J Branson, F Bretz, B Dharan… - Statistics in …, 2020 - Taylor & Francis
The COVID-19 pandemic has a global impact on the conduct of clinical trials of medical
products. This article discusses implications of the COVID-19 pandemic on clinical research …

On the role of data, statistics and decisions in a pandemic

B Jahn, S Friedrich, J Behnke, J Engel… - AStA Advances in …, 2022 - Springer
A pandemic poses particular challenges to decision-making because of the need to
continuously adapt decisions to rapidly changing evidence and available data. For example …

A multi-component intervention (NEXpro) reduces neck pain-related work productivity loss: a randomized controlled trial among Swiss office workers

AM Aegerter, M Deforth, T Volken, V Johnston… - Journal of occupational …, 2023 - Springer
Purpose Neck pain is common among office workers and leads to work productivity loss.
This study aimed to investigate the effect of a multi-component intervention on neck pain …

The impact of COVID-19 on the cell and gene therapies industry: Disruptions, opportunities, and future prospects

T Qiu, Y Wang, S Liang, R Han, M Toumi - Drug discovery today, 2021 - Elsevier
Abstract Coronavirus 2019 (COVID-19) has caused significant disruption to the cell and
gene therapy (CGT) industry, which has historically faced substantial complexities in supply …

Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints

EL Meyer, P Mesenbrink, NA Di Prospero, JM Pericàs… - Plos one, 2023 - journals.plos.org
Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver
disease (NAFLD) and a disease with high unmet medical need. Platform trials provide great …