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Frank Pétavy

European Medicines Agency

18

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224

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The Use of CDISC Standards for Real-World Data (RWD): Expert Perspectives from a Qualitative Delphi Survey (Preprint)

2021 JMIR medical informatics
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The use of a variable representing compliance improves accuracy of estimation of the effect of treatment allocation regardless of discontinuation in trials with incomplete follow-up

2020 Statistics in Biopharmaceutical Research
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EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.

2020 Oncologist
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A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

2020 Trials
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Current statistical considerations and regulatory perspectives on the planning of confirmatory basket, umbrella and platform trials.

2020 Clinical Pharmacology & Therapeutics
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Beyond “Intent‐to‐treat” and “Per protocol”: Improving assessment of treatment effects in clinical trials through the specification of an estimand

2019 British Journal of Clinical Pharmacology
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Are novel, non‐randomised analytic methods fit for decision‐making? The need for prospective, controlled and transparent validation

2019 Clinical Pharmacology & Therapeutics
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The changing landscape of data monitoring committees-Perspectives from regulators, members, and sponsors

2018 Biometrical Journal
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Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency

2018 Trials
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The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations

2018 British Journal of Clinical Pharmacology
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Citations (15)