Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study

Bakouny, Ziad; Labaki, Christopher; Bhalla, Sheena; Schmidt, Andrew; Steinharter, John A.; Cocco, Jennifer; Tremblay, Douglas; Awad, Mark M.; Kessler, Alaina J.; Haddad, Robert I.; Evans, Michelle V.; Busser, Fiona; Wotman, Michael; Curran, Catherine; Zimmerman, Brittney S.; Bouchard, Gabrielle; Jun, Tomi; Nuzzo, Pier Vitale; Qin, Qian; Hirsch, Laure; Feld, Jonathan; Kelleher, Kaitlin M.; Seidman, Danielle; Huang, Hsin-Hui; Anderson-Keightly, Heather; Alaiwi, Sarah Abou; Champagne, Catherine M.; Rosenbloom, Talia D.; Stewart, Penina S.; Johnson, Bruce E.; Trinh, Quoc‐Dien; Tolaney, Sara M.; Galsky, Matthew D.; Choueiri, Toni K.; Doroshow, Deborah Blythe

doi:10.1016/j.annonc.2022.04.071

Cited by 23 publications

(17 citation statements)

References 12 publications

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“…The delivery of cancer services was severely impacted by the COVID-19 pandemic. Effects upon cancer surgery [18, 19], chemotherapy [20] and cancer research [21] have been well described. In pancreatic cancer, centres have described impact upon the entire pathway, including diagnostic, staging as well as treatment delivery [22].…”

Section: Discussionmentioning

confidence: 99%

A national audit of pancreatic enzyme prescribing in pancreatic cancer from 2015 to 2023 in England using OpenSAFELY-TPP

Lemańska

Andrews

Fisher

et al. 2022

Preprint

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Background: Cancer treatments were variably disrupted during the COVID-19 pandemic. Despite UK national guidelines recommending pancreatic enzyme replacement therapy to all people with unresectable pancreatic cancer, observational studies demonstrate under-prescribing. Aim: To investigate the impact of the COVID-19 pandemic on the prescribing of pancreatic enzyme replacement to people with unresectable pancreatic cancer. Methods: With the approval of NHS England, we conducted a cohort study using 24 million health records through the OpenSAFELY-TPP research platform. We modelled the effect of COVID-19 with multivariable linear regression. Results: We found no reduction in pancreatic enzyme replacement therapy during the COVID-19 pandemic. Overall, since 2015, the rates of prescribing increased steadily over time by 1% every year. The national rates ranged from 41% in 2015 to 48% in 2022. There was substantial regional variation. The highest rates of 50% to 60% were in the West Midlands and lowest (20% to 30%) in London. Conclusions: In contrast to many other treatments, prescribing of pancreatic enzyme replacement therapy was not affected during the COVID-19 pandemic. Although overall rates increased over time, substantial under-prescribing existed at the end of this study (March 2022). At just under 50% in 2022, the rates were still below the recommended 100% standard. Prior work evaluating quality of care in this area relied on manual audits which come at increased cost and reduced frequency of updates. With the methodological advantage of OpenSAFELY, we established an automated audit which allows for regular updates.

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Section: Discussionmentioning

confidence: 99%

A national audit of pancreatic enzyme prescribing in pancreatic cancer from 2015 to 2023 in England using OpenSAFELY-TPP

Lemańska

Andrews

Fisher

et al. 2022

Preprint

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“…There are many reasons for the negative impact on cancer clinical trials, including travel restrictions, research staff being redeployed to frontline clinical activities and a significant decrease in the number of cancer patients visiting health units [ 105 ]. However, both patients’ visits to health centers and trial activations continuously recovered during the subsequent periods of the pandemic and, despite the ongoing nature of the pandemic, have now returned to almost normal levels [ 106 ].…”

Section: The Impact Of Covid-19 On Cancer Patientsmentioning

confidence: 99%

Delineating the SARS-CoV-2 Induced Interplay between the Host Immune System and the DNA Damage Response Network

et al. 2022

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COVID-19 is an infectious disease caused by the SARS-CoV-2 coronavirus and characterized by an extremely variable disease course, ranging from asymptomatic cases to severe illness. Although all individuals may be infected by SARS-CoV-2, some people, including those of older age and/or with certain health conditions, including cardiovascular disease, diabetes, cancer, and chronic respiratory disease, are at higher risk of getting seriously ill. For cancer patients, there are both direct consequences of the COVID-19 pandemic, including that they are more likely to be infected by SARS-CoV-2 and more prone to develop severe complications, as well as indirect effects, such as delayed cancer diagnosis or treatment and deferred tests. Accumulating data suggest that aberrant SARS-CoV-2 immune response can be attributed to impaired interferon signaling, hyper-inflammation, and delayed adaptive immune responses. Interestingly, the SARS-CoV-2-induced immunological abnormalities, DNA damage induction, generation of micronuclei, and the virus-induced telomere shortening can abnormally activate the DNA damage response (DDR) network that plays a critical role in genome diversity and stability. We present a review of the current literature regarding the molecular mechanisms that are implicated in the abnormal interplay of the immune system and the DDR network, possibly contributing to some of the COVID-19 complications.

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“…There was a 60% decrease in the number of launches of oncology clinical trials of drugs and biological therapies on a commercial clinical trial platform during the pandemic [6]. Similarly, many other centres have reported declines in research activities due to COVID-19 [7][8][9][10][11].…”

Section: The Impact Of Covid-19 On Cancer Researchmentioning

confidence: 99%

Virtual oncology research-different models and lessons learned

Ranganathan

Pramesh

2022

Current Opinion in Supportive &Amp; Palliative Care

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Purpose of reviewThe COVID-19 pandemic posed several challenges to cancer research including halting of trials, reduced recruitment and protocol violations related to inflexible processes followed in clinical trials. Researchers adopted innovative measures to mitigate these problems and continue studies without compromising their quality. This review collates these adaptations that could well continue after the pandemic. Recent findingsThe COVID-19 pandemic forced researchers globally to adopt innovative measures to overcome the challenges of the pandemic. These included protocol amendments to adjust to the pandemic and travel restrictions, and increased use of digital technologies. 'Virtual' clinical trials were conducted increasingly with adaptations in ethics and regulatory approvals, patient recruitment and consenting, study interventions and delivery of study medications, trial assessments, and monitoring. Many of these adaptations are safe and feasible, without compromising study quality and data integrity. Although these may not be universally applicable in all types of research, they bring many benefits including more diverse patient participation, less burden on patients for study procedures and reduced resources to conduct trials.

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Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study

Cited by 23 publications

References 12 publications

A national audit of pancreatic enzyme prescribing in pancreatic cancer from 2015 to 2023 in England using OpenSAFELY-TPP

A national audit of pancreatic enzyme prescribing in pancreatic cancer from 2015 to 2023 in England using OpenSAFELY-TPP

Delineating the SARS-CoV-2 Induced Interplay between the Host Immune System and the DNA Damage Response Network

Virtual oncology research-different models and lessons learned

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