ArticleStatistics in biopharmaceutical research2020
Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?
Article in Statistics in biopharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic review of available software for multi-arm multi-stage and platform clinical trial design.Trials · 2021Pooled it
- A Multi-component Intervention (NEXpro) Reduces Neck Pain-Related Work Productivity Loss: A Randomized Controlled Trial Among Swiss Office Workers.Journal of occupational rehabilitation · 2023Trial
- Cluster randomised trial of a complex interprofessional intervention (interprof ACT) to reduce hospital admission of nursing home residents.Age and ageing · 2023Trial
- Trial
- Adaptive versus fixed designs in confirmatory clinical trials: centering the choice on ethics.Clinical trials (London, England) · 2026Article
- Article
- A REDCap advanced randomization module to meet the needs of modern trials.Journal of biomedical informatics · 2025Article
- Statistical methods for clinical trials interrupted by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic: A review.Statistical methods in medical research · 2024Review
- The impact of heterogeneity on the analysis of platform trials with normally distributed outcomes.BMC medical research methodology · 2024Article
- Point estimation for adaptive trial designs II: Practical considerations and guidance.Statistics in medicine · 2023Review
- Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial.Statistical methods in medical research · 2023Article
- Point estimation for adaptive trial designs I: A methodological review.Statistics in medicine · 2023Review
- Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints.PloS one · 2023Article
- Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials.Pharmaceutical statistics · 2022Article
- The Impact of COVID-19 on the Initiation of Clinical Trials in Europe and the United States.Clinical pharmacology and therapeutics · 2022Article
- Design aspects of COVID-19 treatment trials: Improving probability and time of favorable events.Biometrical journal. Biometrische Zeitschrift · 2022Article
- Health Product Manufacturers and Innovators COVID-19 Impact Assessment: Lessons Learned and Compelling Needs.NAM perspectives · 2022Review
- Analysis of the COVID-19 Vaccine Development Process: an Exploratory Study of Accelerating Factors and Innovative Environments.Journal of pharmaceutical innovation · 2022Article
- On the role of data, statistics and decisions in a pandemic.Advances in statistical analysis : AStA : a journal of the German Statistical Society · 2022Article
- Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow.Statistics in biopharmaceutical research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 by the World Health Organization. The pandemic has a number of consequences for ongoing clinical trials in non-COVID-19 conditions. Motivated by four current clinical trials in a variety of disease areas we illustrate the challenges faced by the pandemic and sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve Type I error rate control, if required; (iii) how to deal with potential treatment effect heterogeneity; (iv) how to use early read-outs; and (v) how to use Bayesian techniques. In more detail approaches to resizing a trial affected by the pandemic are developed including considerations to stop a trial early, the use of group-sequential designs or sample size adjustment. All methods considered are implemented in a freely available R shiny app. Furthermore, regulatory and operational issues including the role of data monitoring committees are discussed.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.