Reimagining Global Oncology Clinical Trials for the Postpandemic Era: A Call to Arms

Saini, Kamal S; Heras, Begoña de las; Plummer, Ruth; Moreno, Víctor; Romano, Marco; Castro, Javier de; Aftimos, Philippe; Fredriksson, J.; Bhattacharyya, Gouri Shankar; Olivo, Martin; Schiavon, Gaia; Punie, Kevin; Garcı́a-Foncillas, Jesús; Rogata, Ernesto; Pfeiffer, Richie; Orbegoso, Cecilia; Morrison, Kenneth; Curigliano, Giuseppe; Chin, Lynda; Saini, Monika; Rekdal, Øystein; Anderson, S. Eric; Cortés, Javier; Leone, Manuela; Dancey, Janet; Twelves, Chris; Awada, Ahmad

doi:10.1200/go.20.00346

Cited by 18 publications

(21 citation statements)

References 49 publications

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“…The term ‘decentralised clinical trials’ is used to define those executed through telemedicine and mobile or local health care providers, using processes and technologies that differ from the traditional clinical trial model [ 45 ]. Examples include the use of telemedicine, teleconsent, wearable devices and smartphone applications for educational material, reminders and collection of patient-reported outcomes [ 46 ].…”

Section: Potential Solutionsmentioning

confidence: 99%

Section: Potential Solutionsmentioning

confidence: 99%

“…In order to ensure fluidity of the process, there are a number of issues of basic technology that must be overcome, including enabling a secure and reliable telephone/video contact, as well as financial reimbursement and legal and regulatory issues [46]. Some examples specific to older adults in cancer clinical trials include the use of electronic signature to avoid unnecessary hospital visits for consenting, virtual screening assessment to determine eligibility for investigation and treatment, and routine follow-up appointments [47].…”

Section: Decentralised Clinical Trialsmentioning

confidence: 99%

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Current Challenges Faced by Cancer Clinical Trials in Addressing the Problem of Under-Representation of Older Adults: A Narrative Review

2021

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The number of older adults living with cancer is increasing. There is a clear lack of representation of older adults in clinical trials, including cancer trials. Reasons for this are multifactorial and complex and include protocol, patient and sponsor factors. Potential solutions to overcome issues with trial design include varied methods of recruitment with flexible inclusion criteria. Possible alternatives to randomised trials include prospective cohort studies, pragmatic trials and the use of national population-based data sets. Patient factors may be addressed by integration of geriatric assessment, so patients can be randomised or treated based on their individual needs. Additionally, standard protocols for including older adults with cognitive impairment should be developed, rather than automatic exclusion. Increased effort is needed from sponsors and governing health care bodies to make recruitment of older adults to clinical trials standard.

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Section: Potential Solutionsmentioning

confidence: 99%

Section: Potential Solutionsmentioning

confidence: 99%

Section: Decentralised Clinical Trialsmentioning

confidence: 99%

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Current Challenges Faced by Cancer Clinical Trials in Addressing the Problem of Under-Representation of Older Adults: A Narrative Review

2021

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“…Therefore, research in this field needs to continue to be supported both scientifically and economically [32] . The optimal use of modern technologies such as video, apps or mobile phones, electronic consent and telemedicine consultation could replace some protocol mandatory hospital visits and provide an efficient tool to greatly reduce the bureaucratic burden and methods of data entry [33] .…”

Section: Impact Of Covid-19 Pandemic On Pediatric Cancer Clinical Trimentioning

confidence: 99%

Managing children with brain tumors during the COVID-19 era: Don’t stop the care!

Capozza¹,

Triarico²,

Attinà³

et al. 2021

Computational and Structural Biotechnology Journal

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“…The pandemic has had a severe impact on oncology care and research [2][3][4][5][6][7]. While the majority of patients with COVID-19 remain pauci-or asymptomatic, about 10-15% have a more severe disease, with some developing a clinical syndrome that shares certain similarities with malignancy, including hyper-inflammation, immune dysfunction, and of most concern, widespread thrombosis [8], with microangiopathy being of particular concern [9].…”

Section: Introductionmentioning

confidence: 99%

Emerging issues related to COVID-19 vaccination in patients with cancer

et al. 2021

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Coronavirus disease 2019 (COVID-19) has resulted in millions of deaths globally. The pandemic has had a severe impact on oncology care and research. Patients with underlying cancer are more vulnerable to contracting COVID-19, and also have a more severe clinical course following the infection. The rollout of COVID-19 vaccines in many parts of the world has raised hopes of controlling the pandemic. In this editorial, the authors outline key characteristics of the currently approved COVID-19 vaccines, provide a brief overview of key emerging issues such as vaccine-induced immune thrombotic thrombocytopenia and SARS-CoV-2 variants of concern, and review the available data related to the efficacy and side effects of vaccinating patients with cancer.

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Reimagining Global Oncology Clinical Trials for the Postpandemic Era: A Call to Arms

Cited by 18 publications

References 49 publications

Current Challenges Faced by Cancer Clinical Trials in Addressing the Problem of Under-Representation of Older Adults: A Narrative Review

Current Challenges Faced by Cancer Clinical Trials in Addressing the Problem of Under-Representation of Older Adults: A Narrative Review

Managing children with brain tumors during the COVID-19 era: Don’t stop the care!

Emerging issues related to COVID-19 vaccination in patients with cancer

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