A risk-based approach to experimental early phase clinical trials during the COVID-19 pandemic

Tiu, Crescens; Shinde, Rajiv; Yap, Christina; Baikady, Bindumalini Rao; Banerji, Udai; Minchom, Anna; Bono, Johann S. de; Lopez, Juanita

doi:10.1016/s1470-2045(20)30339-9

Cited by 4 publications

(5 citation statements)

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“…There has also been a significant impact on trial processes [41], including monitoring and audit, with new remote systems being required and deployment of staff to working from home conditions. Consequently, the pandemic has generated calls to streamline cancer trial methodology and paperwork, and to reduce the number of mandatory hospital visits [42].…”

Section: Impact Of the Pandemic On Cancer Trialsmentioning

confidence: 99%

Cancer Treatment and Research During the COVID-19 Pandemic: Experience of the First 6 Months

et al. 2020

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The coronavirus disease-2019 (COVID-19) pandemic has had a significant impact on patients with underlying malignancy. In this article, we summarize emerging data related to patients with cancer and COVID-19. Among patients with COVID-19, a higher proportion have an underlying diagnosis of cancer than seen in the general population. Also, patients with malignancy are likely to be more vulnerable than the general population to contracting COVID-19. Mortality is significantly higher in patients with both cancer and COVID-19 compared with the Digital Features To view digital features for this article go to

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Section: Impact Of the Pandemic On Cancer Trialsmentioning

confidence: 99%

Cancer Treatment and Research During the COVID-19 Pandemic: Experience of the First 6 Months

et al. 2020

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“…12+ weeks on trial, no safety concerns). 30 Further national collaboration between clinicians, trial sponsors, and researchers is required to inform the future debate on this important area.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, remote methods of monitoring are even more relevant for immuno-compromised trial patients who are especially vulnerable during the coronavirus disease 2019 (COVID-19) pandemic, facilitating the triage of patients and reducing the need for face-to-face clinical encounters where the risk–benefit ratio deem it appropriate. 29 , 30 Electronic methods also enable the use of automated alerts for severe symptoms, which could facilitate the management of patient-reported adverse events in trials, 31 but further work is needed to explore a variety of stakeholders’ views and whether this is acceptable in an early phase trial setting.…”

Section: Introductionmentioning

confidence: 99%

Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff

et al. 2020

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Background/aims New classes of cancer drugs bring a range of unknown and undesirable adverse events. Adverse event monitoring is essential in phase I trials to assess toxicity and safety. In phase II, the focus is also on efficacy but robust data on adverse events continue to inform the safety and the adverse event profile. Standard, clinician-led monitoring has been shown to underestimate patients’ symptoms. Hence, patient-reported adverse event monitoring has been argued to complement and improve the information on adverse events in early phase clinical trials. With advances in information technology, real-time patient self-reported adverse events in trials are feasible. This study explored the experiences and procedures for reporting adverse events in early phase trials among patients, clinical staff, and trial staff, and their views on using an electronic patient-reported outcome adverse event system in this setting. Methods Qualitative interviews were conducted with patients, purposively sampled across ages, gender, and different phases of trials, and with clinical and trial-related staff involved in early phase trials (e.g. consultants, research nurses, hospital-based trial assistants/data managers, trial unit management staff). Interviews explored patient experiences and views on current adverse event reporting processes and electronic patient-reported outcome adverse event reporting. Framework analysis techniques were used to analyse the data. Results Interviewees were from two hospital trusts with early phase portfolios in England and a trial unit, and included sixteen patients, five consultants, four research nurses, five hospital-based trial staff, and two trial unit staff. Interviews identified three key themes (patient experiences, data flow, and views on electronic patient-reported outcome adverse event reporting). Stakeholders emphasised the intensity of trials for patients and the importance of extensive information provision within the uncertainty of early phase trial drugs. Regular face-to-face appointments for patients supplemented by telephone contact aimed to capture any adverse events. Delayed or under-reporting of mild- or low-severity symptoms was evident among patients. Hospital-based staff highlighted the challenges of current data collection including intense timescales, monitoring by trial sponsors, and high workload. Positive views on electronic patient-reported outcome adverse events highlighted that this could provide a more comprehensive and accurate view on the side effects of new drugs. Clinical staff emphasised patient safety and the need for clear responsibilities for monitoring. The need for careful decision-making about data flow and symptom attribution was highlighted; with trial unit staff emphasising the need for clinician review. Conclusion Technology advances mean it is timely to explore the benefits and challenges of electronic patient-reported outcome adverse event reporting. This is a complex area warranting further consideration within the trial community. We have developed an online patient self-reporting tool and a small pilot with early phase trial patients is underway.

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“…Though trial recruitment was slowed or halted in anticipation of the expected decline in site capacity, mitigation strategies stabilised and even partially recovered numbers in the face of subsequent waves [42,43], allowing some trial sites to remain operational in heavily pandemic-affected regions. It was feasible even for some experimental and demanding EP trials to be continued in a safe and scientifically rigorous manner using a risk-adapted approach [44,45].While these adaptive strategies allowed some cancer trials to stay afloat throughout the ordeal, the rationalised approach was most comprehensively applied to new studies conceived in response to the pandemic itself. The large-scale, adaptive, randomised, UK-based RECOVERY trial for inpatient COVID-19 treatment employed drastically rationalised site set-up and training, consent, eligibility assessment, endpoints, data monitoring and follow-up, along with preferential allocation of large amounts of trials infrastructure and expedient approval, and the use of data linkage.…”

Section: Effect Of Covid-19 On Cancer Care and Trials And Mitigation ...mentioning

confidence: 99%

Revitalising cancer trials post-pandemic: time for reform

et al. 2023

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The COVID-19 pandemic posed significant risk to the health of cancer patients, compromised standard cancer care and interrupted clinical cancer trials, prompting dramatic streamlining of services. From this health crisis has emerged the opportunity to carry forward an unexpected legacy of positive reforms to clinical cancer research, where conventionally convoluted approvals processes, inefficient trial design, procedures and data gathering could benefit from the lessons in rationalisation learned during the pandemic.

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A risk-based approach to experimental early phase clinical trials during the COVID-19 pandemic

Cited by 4 publications

References 0 publications

Cancer Treatment and Research During the COVID-19 Pandemic: Experience of the First 6 Months

Cancer Treatment and Research During the COVID-19 Pandemic: Experience of the First 6 Months

Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff

Revitalising cancer trials post-pandemic: time for reform

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