Article
Impact of COVID-19 on estimands considerations in Oncology
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Authors
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Martin Oliver Sailer
- Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
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Evgeny Degtyarev
- Novartis, Basel, Switzerland
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Jiangxiu Zhou
- GSK, Collegeville, United States
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Michelle Casey
- Pfizer, Collegeville, United States
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Rui Tang
- Servier Pharmaceuticals, Boston, United States
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Feng Liu
- Astra Zeneca, Gaithersburg, United States
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Yue Shentu
- Merck Sharp & Dohme, Rahway, United States
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Godwin Yung
- Takeda Pharmaceuticals, Cambridge, United States
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Yi Liu
- Nektar Therapeutics, San Francisco, United States
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Kaspar Rufibach
- Methods, Collaboration, and Outreach Group (MCO), Department of Biostatistics, Hoffmann-La Roche Ltd., Basel, Switzerland
| Published: | February 26, 2021 |
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Outline
Text
An addendum to the guideline on statistical principles for clinical trials was issued in 2019 [1] introducing the estimands framework. This framework aims to align trial objectives with study design and statistical analysis. An industry working group for estimands targeted specifically at Oncology was formed to exchange examples and methods suitable for implementing the estimands framework within Oncology clinical trials [2].
The Coronavirus Disease 2019 (COVID-19) is an emerging respiratory infectious disease caused by SARS-CoV-2. First confirmed in Wuhan, China, the virus has since spread across the globe, leading to more than half-a-million infections, twenty-five thousand deaths, and a quarter of the world's population under lockdown (as of March 27, 2020). On March 11, 2020, the World Health Organization (WHO) officially declared COVID-19 a pandemic.
To mitigate the impact of COVID-19 on the conduct and interpretability of ongoing clinical trials, the EMA issued a draft guidance [3] and the FDA issued an emergency final guidance [4]. As noted by the agencies, both the virus as well as actions taken to reduce its spread can potentially impact access to treatment and protocol specified assessments. Therefore, per the estimand framework, intercurrent events and missing data resulting from the COVID-19 pandemic need to be carefully considered in the estimation of treatment effect.
The EFSPI working group on estimands in Oncology collected and shared examples of trial design and analysis measures to address potential difficulties in study result interpretation due to the pandemic.
In this talk we present considerations for efficacy studies in Oncology, using as examples late-phase time-to-event trials and studies with early phase binary endpoints such as objective response.
We share our experience in the implementation of these considerations in the months following the pandemic declaration.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
References
- 1.
- ICH. Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials E9 (R1). Final version. 2019 Nov 20.
- 2.
- Rufibach K, Degtyarev E, Siegel J, Stalbovskaya V, Sun S. Estimand framework in Oncology drug development – impact and opportunities. In: PSI conference; 2019 Jun 4; London.
- 3.
- European Medicines Agency. Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials. EMA/158330/2020. Draft guidance. 2020 Mar 25.
- 4.
- United States Food and Drug Administration. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards. Final Guidance. [Updated 2020 Mar 27]. Available from:https://www.fda.gov/media/136238/download
