COVID-19 impact on oncology clinical trials: a 1-year analysis

Upadhaya, Samik; Yu, Jia; Hodge, Jeffrey; Campbell, Jay

doi:10.1038/d41573-021-00086-8

Cited by 28 publications

(19 citation statements)

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“…Indeed, some trial registries observed a reduction down to 60% in launches after the beginning of the pandemic ( 21 ). While reactivation of intervention studies in oncology occurred speedily in high-income countries ( 16 , 22 ), the interviewed investigators in our analysis reported the effect of these challenges for recruitment and follow-up remaining after resuming research activities.…”

Section: Discussionmentioning

confidence: 95%

Cancer Research in the Time of COVID-19: A Colombian Narrative

Murillo

Fernández-Deaza

Zuluaga

et al. 2022

Front. Public Health

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Cancer research is deficient in Colombia and efforts and resources diverted due to the COVID-19 pandemic could worsen the situation. We explore the impact of the pandemic on cancer research funding, output, and conduct. We sought information at national level and used the experience of an academic reference center to contrast the impact at institutional level. We searched databases and official documents of national governmental institutions, trial registries, hospital registries, and the Web of Science. We interviewed principal investigators (PIs) to retrieve information on the conduct of cancer research. A decline in resource availability and new proposals was observed at the national level with a shift to COVID-19 related research. However, at institutional level there was no decline in the number of cancer research proposals. The predominance of observational studies as opposed to the preponderance of clinical trials and basic science in high-income countries may be related to the lower impact at institutional level. Nevertheless, we found difficulties similar to previous reports for conducting research during the pandemic. PIs reported long recovery times and a great impact on research other than clinical trials, such as observational and qualitative studies. No significant impact on research output was observed. Alternatives to ensure research continuity such as telemedicine and remote data collection have scarcely been implemented given limited access and low technology literacy. In this middle-income setting the situation shows a notable dependency of international collaborations to develop research on COVID-19 and cancer and to overcome challenges for cancer research during the pandemic.

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Section: Discussionmentioning

confidence: 95%

Cancer Research in the Time of COVID-19: A Colombian Narrative

Murillo

Fernández-Deaza

Zuluaga

et al. 2022

Front. Public Health

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“…This is in line with the findings of Upadhaya et al, who showed that the impact of the pandemic on ongoing oncology trials lessened from June 2020. 25 Along the same lines, Unger and Xiao investigated trial data for interventional and observational oncology, cardiovascular, and mental health studies from January 2015 through September 2020 based on clinicaltrials.gov for the United States and globally, and concluded that for these indications the COVID-19 outbreak was associated with a decrease in new clinical trial activations. 26 Similarly, the analysis by Lamont et al 27 demonstrates a decrease in trials initiated in oncology.…”

Section: The Impact Of Covid-19 On the Initiation Of Clinical Trials ...mentioning

confidence: 99%

The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States

Lasch

Psarelli

Herold

et al. 2022

Clin Pharma and Therapeutics

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The coronavirus disease 2019 (COVID-19) pandemic impacts the conduct of clinical trials and challenges clinical trial sponsors. WHAT QUESTION DID THIS STUDY ADDRESS?  What is the impact of the COVID-19 pandemic on the initiation of phase II and III clinical trials, both overall and for non-COVID-19 related trials, in Europe and the United States? WHAT DOES THIS STUDY ADD TO OUR KNOW-LEDGE?  This study indicates that the COVID-19 pandemic affected the initiation of clinical trials overall and of non-COVID-19 trials. Although an increase in the overall numbers of clinical trials could be observed both in Europe and the United States, the number of initiated non-COVID-19 trials is reduced, with a slightly larger relative decrease in the United States. Short-term trends are also described. HOW MIGHT THIS CHANGE CLINICAL PHARMA-COLOGY OR TRANSLATIONAL SCIENCE? The investigation and findings are a starting point to understand the impact of the COVID-19 pandemic on clinical trial initiation. The analysis allows to be rerun to capture more recent developments during and after the pandemic.

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“…Due to the high number of COVID-19 cases during the pandemic in 2020, trial initiation dropped by up to 30 % in the USA 8 . During the first wave of the pandemic, more than 1000 trials were stopped as a consequence 9 . Social distancing and quarantine measures have negatively affected patients participation in clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Viral kinetic modeling and clinical trial simulation predicts disruption of respiratory disease trials by non-pharmaceutical COVID-19 interventions

Arsène¹,

Couty²,

Faddeenkov³

et al. 2021

Preprint

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Clinical research in infectious respiratory diseases has been profoundly affected by non-pharmaceutical interventions (NPIs) against COVID-19. On top of trial delays or even discontinuation which have been observed in all disease areas, NPIs altered transmission pattern of many seasonal respiratory viruses which followed regular patterns for decades before the pandemic. Clinical trial design based on pre-pandemic historical data therefore needs to be put in question. In this article, we show how knowledge-based mathematical modeling can be used to address this issue. We set up an epidemiological model of respiratory tract infection (RTI) sensitive to a time dependent between-host transmission rate and coupled this model to a mechanistic description of viral RTI episodes in an individual patient. By reducing the transmission rate when the lockdown was introduced in the United Kingdom in March 2020, we were able to reproduce the perturbed 2020 RTI disease burden data. Using this setup, we simulated several NPIs scenarios of various strength (none, mild, medium, strong) and conducted placebo-controlled in silico clinical trials in pediatric patients with recurrent RTIs (RRTI) quantifying annual RTI rate distributions. In interventional arms, virtual patients aged 1-5 years received the bacterial lysate OM-85 (approved in several countries for the prevention of pediatric RRTIs) through a pro-type I immunomodulation mechanism of action described by a physiologically based pharmacokinetics and pharmacodynamics approach (PBPK/PD). Our predictions showed that sample size estimates based on the ratio of RTI rates (or the post-hoc power of fixed sample size trials) are not majorly impacted under NPIs which are less severe (none, mild and medium NPIs) than a strict lockdown (strong NPI). However, NPIs show a stronger impact on metrics more relevant for assessing the clinical relevance of the effect such as absolute benefit. This dichotomy shows the risk that successful trials (even with their primary endpoints being met) still get challenged in risk benefit assessment during the review of market authorization. Furthermore, we found that a mild NPI scenario already affected the time to recruit significantly when sticking to eligibility criteria complying with historical data. In summary, our model predictions can help rationalize and forecast post-COVID-19 trial feasibility. They advocate for gauging absolute and relative benefit metrics as well as clinical relevance for assessing efficacy hypotheses in trial design and they question eligibility criteria misaligned with the actual disease burden.

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COVID-19 impact on oncology clinical trials: a 1-year analysis

Cited by 28 publications

References 0 publications

Cancer Research in the Time of COVID-19: A Colombian Narrative

Cancer Research in the Time of COVID-19: A Colombian Narrative

The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States

Viral kinetic modeling and clinical trial simulation predicts disruption of respiratory disease trials by non-pharmaceutical COVID-19 interventions

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