ArticleContemporary clinical trials2022
Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis.
Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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
4 citing papers in PubMed.
- Real-world clinical outcomes of patients with early-stage TNBC and BRCAm who were treated with adjuvant capecitabine in the United States.Breast cancer research and treatment · 2026Observational
- Pembrolizumab in advanced malignant peripheral nerve sheath tumors: a single-arm phase 2 trial.NPJ precision oncology · 2026Article
- 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 reliability and integrity of overall survival data based on follow-up records only and potential solutions to the challenges.The Lancet regional health. Western Pacific · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundTo identify and assess via simulation the impact of COVID-19 pandemic on oncology trials and discuss potential mitigation strategies for study design, data collection, endpoints and analyses.
methodsWe simulated clinical trials to evaluate the COVID-19 impact on overall survival and progression-free survival. We evaluated survival in single-region trials with different proportions of impacted patients across treatment arms, and in multi-region randomized trials with different proportions of impacted patients across regions. We also assessed the impact on PFS when the missingness of disease assessment and censoring rules vary. Impact on the trial success and robustness of statistical inference was summarized.
resultsWithout regional impact, the impact on OS analysis is minimal if proportions of impacted patients are similar across arms, however, if a larger proportion of treatment arm patients are impacted, trials may suffer substantial power loss and underestimate treatment effect size. For multi-region trials, if more treatment arm patients are enrolled from more severely impacted regions, trials also have poorer performance. For PFS analysis, the intent-to-treat rule performs well even when the treatment arm patients are more likely to miss disease assessments, while the consecutive-missing censoring rule may lead to poorer performance.
conclusionCOVID-19 affects oncology trials. Simulations would be highly informative to Data Monitoring Committee in understanding the impact and making appropriate recommendations, upon which the sponsor could start planning potential remedies. We also recommend a decision tree for choosing the appropriate methods for PFS evaluation in the presence of missing disease assessments due to COVID-19.
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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.