Recommendations from national regulatory agencies for ongoing cancer trials during the COVID-19 pandemic

Paula, Bruno de; Araújo, Indiara Iris de Oliveira; Bandeira, Lívia Liberata Barbosa; Barreto, Nathalia Monerat Pinto Blazuti; Doherty, Gary J.

doi:10.1016/s1470-2045(20)30226-6

Cited by 27 publications

(24 citation statements)

References 2 publications

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“…Clinical trials deserve specific consideration in the situation of a pandemic as experienced now. 6 Phase I trials seeking to establish maximum tolerated doses with uncertain individual patient benefit need to be viewed with caution unless the intervention is highly unlikely to compromise immune function or to cause pulmonary toxicity. For most phase II trials, patients already enrolled onto trials and being stable may be kept on trial with a careful risk:benefit ratio from the patient perspective, not from a trial perspective.…”

Section: Clinical Trialsmentioning

confidence: 99%

How we treat patients with brain tumour during the COVID-19 pandemic

Weller

Preusser

2019

ESMO Open

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The COVID-19 pandemic has created major insecurities regarding whether we can and should maintain the current standards of diagnosis and treatment and access to care for patients with cancer. This is particularly true in the field of neuro-oncology, where the perceived benefit of therapeutic interventions is often low, although this notion is partially incorrect. We acknowledge that the recommendations for care of patients with cancer have become a moving target and that all recommendations are subject to modification based on national and institutional regulations. Still, some important considerations and proposals may apply broadly. First, it is important to note that old age and cardiovascular and pulmonary co-morbidities are the major risk factors for experiencing a severe course of and for dying of COVID-19, not chronic immunosuppression and cancer. Second, many of the considerations on how we should adapt clinical practice in neuro-oncology in view of COVID-19 that are now dominating discussions at local tumour boards, as well as on the institutional level and within societies of neuro-oncology, are not novel but have been valid before and only now have become a priority. More than ever, it seems to be mandatory to adhere to evidence-based medicine and not to prescribe potentially toxic, notably immunsuppresssive systemic therapy where evidence for efficacy is low. Furthermore, it is more obvious now that oncologists must not miss the right time for advance care planning, that is, supporting patients in understanding and sharing their personal values, life goals and preferences regarding future medical care. The major psychological impact of transforming oncology care to teleconferences and videoconferences and of the important strict recommendation of social distancing must not be overlooked in a patient population that is characterised by significant prevalence of cognitive decline and by the general perception that their life span may not exceed the life span of the COVID-19 pandemic

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Section: Clinical Trialsmentioning

confidence: 99%

How we treat patients with brain tumour during the COVID-19 pandemic

Weller

Preusser

2019

ESMO Open

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“…Thousands of deaths were registered in only a few months. Many activities in-and outside hospitals significantly slowed down, oncology drug development included [1,2].…”

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confidence: 99%

Oncology clinical trials during the COVID-19 outbreak: Lessons learnt during the crisis and future opportunities

Fontana

Arkenau

2020

Cancer Treatment Reviews

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“…The consequences will be far ranging, short-term and mid-term, and the broader challenges COVID-19 offers across societies and economies will slowly make their way into oncology practice. These will include: the shock of unemployment, which will reduce capacity to pay for existing and emerging cancer therapeutics (45,46), heightened social justice issues whereby the pandemic's structural impacts further frame access to cutting-edge oncological care and clinical trials (47), increased polarization along racial, class, political, and ethnic difference and minority experiences of care (45,48), and the enhanced mental health consequences for patients with cancer already experiencing cancer-related psychosocial issues (49). As post-pandemic austerity shapes the experience of living with cancer, these structural vulnerabilities will intersect with the aforementioned challenges of ongoing virtual consultations, as well as worries around physical contact on the part of patients, families, and clinicians.…”

Section: Legacy Effects and The Significance Of Social Change For Oncmentioning

confidence: 99%

The Paradoxical Effects of COVID-19 on Cancer Care: Current Context and Potential Lasting Impacts

Broom

Kenny

Page

et al. 2020

Clinical Cancer Research

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Coronavirus disease 2019 (COVID-19) has fundamentally disrupted the practice of oncology, shifting care onto virtual platforms, rearranging the logistics and economics of running a successful clinical practice and research, and in some contexts, redefining what treatments patients with cancer should and can receive. Since the start of the pandemic in early 2020, there has been considerable emphasis placed on the implications for patients with cancer in terms of their vulnerability to the virus and potential exposure in healthcare settings. But little emphasis has been placed on the significant, and potentially enduring, consequences of COVID-19 for how cancer care is delivered. In this article, we outline the importance of a focus on the effects of COVID-19 for oncology practice during and potentially after the pandemic, focusing on key shifts that are already evident, including: the pivot to online consultations, shifts in access to clinical trial and definitions of "essential care," the changing economics of practice, and the potential legacy effects of rapidly implemented changes in cancer care. COVID-19 is reshaping oncology practice, clinical trials, and delivery of cancer care broadly, and these changes might endure well beyond the short-to mid-term of the active pandemic. Therefore, shifts in practice brought about by the pandemic must be accompanied by improved training and awareness, enhanced infrastructure, and evidence-based support if they are to harness the positives and offset the potential negative consequences of the impacts of COVID-19 on cancer care.

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Recommendations from national regulatory agencies for ongoing cancer trials during the COVID-19 pandemic

Cited by 27 publications

References 2 publications

How we treat patients with brain tumour during the COVID-19 pandemic

How we treat patients with brain tumour during the COVID-19 pandemic

Oncology clinical trials during the COVID-19 outbreak: Lessons learnt during the crisis and future opportunities

The Paradoxical Effects of COVID-19 on Cancer Care: Current Context and Potential Lasting Impacts

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