A single‐arm, multicenter, open‐label phase 2 study of lapatinib as the second‐line treatment of patients with locally advanced or metastatic transitional cell …

…, MR De Groot, P Beuzeboc, R Parikh, F Pétavy… - Cancer, 2009 - Wiley Online Library
BACKGROUND: The treatment of recurrent transitional cell carcinoma (TCC) remains an unmet
clinical need. This study assessed lapatinib, a dual tyrosine kinase inhibitor of epidermal …

[HTML][HTML] FAIR data sharing: the roles of common data elements and harmonization

…, A Sherman, EA Navarro, R Fitzmartin, F Pétavy… - Journal of biomedical …, 2020 - Elsevier
The value of robust and responsible data sharing in clinical research and healthcare is
recognized by patients, patient advocacy groups, researchers, journal editors, and the healthcare …

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

…, B Hofner, F Pétavy… - Clinical …, 2020 - Wiley Online Library
Master protocols have received a growing interest during the last years. By assigning patients
to specific substudies, they aim at targeting and accelerating clinical development. Given …

Are novel, nonrandomized analytic methods fit for decision making? The need for prospective, controlled, and transparent validation

…, H Enzmann, A Humphreys, F Pétavy… - Clinical …, 2020 - Wiley Online Library
Real‐world data and patient‐level data from completed randomized controlled trials are
becoming available for secondary analysis on an unprecedented scale. A range of novel …

Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study

…, E Pedagogos, WG Goodman, F Pétavy… - Nephrology Dialysis …, 2013 - academic.oup.com
Background The ADVANCE study assessed the progression of vascular and cardiac valve
calcification in 360 hemodialysis patients with secondary hyperparathyroidism (sHPT) …

The impact of COVID‐19 on the initiation of clinical trials in Europe and the United States

…, A Mattsson, L Guizzaro, F Pétavy… - Clinical …, 2022 - Wiley Online Library
The coronavirus disease 2019 (COVID‐19) pandemic has a major impact not only on public
health and daily living, but also on clinical trials worldwide. To investigate the potential …

[HTML][HTML] Use of clinical data interchange standards consortium (CDISC) standards for real-world data: expert perspectives from a qualitative Delphi survey

…, M Gong, Q Li, V Popat, F Pétavy… - JMIR medical …, 2022 - medinform.jmir.org
Background Real-world data (RWD) and real-world evidence (RWE) are playing increasingly
important roles in clinical research and health care decision-making. To leverage RWD …

[PDF][PDF] Lapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trial

…, B Audhuy, JP Machiels, F Pétavy… - Journal of Clinical …, 2008 - researchgate.net
Purpose Lapatinib is an orally reversible inhibitor of epidermal growth factor receptor (EGFR)/human
epidermal growth factor receptor 2 (HER-2) tyrosine kinases with demonstrated …

[HTML][HTML] Access to patient-level trial data—a boon to drug developers

HG Eichler, F Pétavy, F Pignatti… - New England Journal of …, 2013 - Mass Medical Soc
Access to Patient-Level Trial Data — A Boon to Drug Developers | NEJM Skip to main content
NEJM Group Follow Us Facebook Twitter Instagram YouTube LinkedIn Prepare to become a …

[HTML][HTML] Control of mild to moderate asthma over 1-year with the combination of salmeterol and fluticasone propionate

…, A Lindberg, AC Jonsson, LG Larsson, F Pétavy… - Respiratory …, 2006 - Elsevier
OBJECTIVE: The aim of this study was to assess asthma control using salmeterol plus
fluticasone propionate (FP) in combination (SFC) versus salmeterol or FP as monotherapy in …