Dataset Information

Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis.

ABSTRACT:

Background

To 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.

Methods

We 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.

Results

Without 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.

Conclusion

COVID-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.

SUBMITTER: Tang RS

PROVIDER: S-EPMC8935956 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis.

Tang Rui Sammi RS Zhu Jian J Chen Tai-Tsang TT Liu Fang F Jiang Xun X Huang Bo B Lee J Jack JJ Beckman Robert A RA

Contemporary clinical trials 20220321

<h4>Background</h4>To 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.<h4>Methods</h4>We 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 di ...[more]

PMID: 35331946

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Project description:BackgroundCOVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct.Patients and methodsThis prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States between December 2019 and June 2021. The primary objective was to assess the enrollment on, accrual to, and activation of oncology therapeutic clinical trials during the pandemic using an institution-wide cohort of (i) new patient accruals to oncological trials, (ii) a manually curated cohort of patients with cancer, and (ii) a dataset of new trial activations.ResultsThe institution-wide cohort included 4756 new patients enrolled to clinical trials from December 2019 to June 2021. A major decrease in the numbers of new patient accruals (-46%) was seen early in the pandemic, followed by a progressive recovery and return to higher-than-normal levels (+2.6%). A similar pattern (from -23.6% to +30.4%) was observed among 467 newly activated trials from June 2019 to June 2021. A more pronounced decline in new accruals was seen among academically sponsored trials (versus industry sponsored trials) (P < 0.05). In the manually curated cohort, which included 2361 patients with cancer, non-white patients tended to be more likely taken off trial in the early pandemic period (adjusted odds ratio: 2.60; 95% confidence interval 1.00-6.63), and substantial pandemic-related deviations were recorded.ConclusionsSubstantial disruptions in clinical trial activities were observed early during the pandemic, with a gradual recovery during ensuing time periods, both from an enrollment and an activation standpoint. The observed decline was more prominent among academically sponsored trials, and racial disparities were seen among people taken off trial.

Project description:BackgroundSurvey data were needed to assess the mental and social health, health related behaviors and compliance with preventive measures of the population during the COVID-19 pandemic. Yet, the pandemic challenged classical survey methods. Time and budgetary constraints at the beginning of the pandemic led to ad hoc recruitment of participants and easily manageable data collection modes. This paper describes the methodological choices and results in terms of participation for the COVID-19 health surveys conducted in Belgium.MethodsThe COVID-19 health surveys refer to a series of ten non-probability web surveys organized between April 2020 and March 2022. The applied recruitment strategies were diverse including, amongst others, a launch through the website and the social media of the organizing research institute. In addition, the survey links were shared in articles published in the national press and participants were requested to share the surveys in their network. Furthermore, participants were asked consent to be re-contacted for next survey editions using e-mail invitations.ResultsThese mixed approaches allowed to reach a substantial number of participants per edition ranging from 49339 in survey 1 to 13882 in survey 10. In addition, a longitudinal component was created; a large share of the same individuals were followed up over time; 12599 participants completed at least 5 surveys. There were, however, sex, age, educational level and regional differences in participation. Post-stratification weighting on socio-demographic factors was applied to at least partly take this into account.ConclusionThe COVID-19 health surveys allowed rapid data collection after the onset of the pandemic. Data from these non-probability web surveys had their limitations in terms of representativeness due to self-selection but were an important information source as there were few alternatives. Moreover, by following-up the same individuals over time it was possible to study the effect of the different crisis phases on, amongst others, the mental health. It is important to draw lessons from these experiences: initiatives in order to create a survey infrastructure better equipped for future crises are needed.

Dataset Information

Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis.

Background

Methods

Results

Conclusion

Publications

Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis.

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