Search Results - "PETAVY, Frank"

Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials by Collignon, Olivier, Gartner, Christian, Haidich, Anna‐Bettina, James Hemmings, Robert, Hofner, Benjamin, Pétavy, Frank, Posch, Martin, Rantell, Khadija, Roes, Kit, Schiel, Anja

“…Master protocols have received a growing interest during the last years. By assigning patients to specific substudies, they aim at targeting and accelerating…”
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The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States by Lasch, Florian, Psarelli, Eftychia‐Eirini, Herold, Ralf, Mattsson, Andrea, Guizzaro, Lorenzo, Pétavy, Frank, Schiel, Anja

“…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…”
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Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation by Eichler, Hans‐Georg, Koenig, Franz, Arlett, Peter, Enzmann, Harald, Humphreys, Anthony, Pétavy, Frank, Schwarzer‐Daum, Brigitte, Sepodes, Bruno, Vamvakas, Spiros, Rasi, Guido

“…Real‐world data and patient‐level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A…”
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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 by Pétavy, Frank, Guizzaro, Lorenzo, Antunes dos Reis, Inês, Teerenstra, Steven, Roes, Kit C.B.

“…There is a key problem in randomised clinical trials as outcomes can be distorted due to informative post‐randomisation events. This is inadequately addressed…”
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Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients by Rohner, Eliane, Grabik, Michael, Tonia, Thomy, Jüni, Peter, Pétavy, Frank, Pignatti, Francesco, Bohlius, Julia

“…Since 2010, the European Medicines Agency (EMA) has provided access to clinical study reports (CSRs). We requested CSRs for randomized controlled trials (RCTs)…”
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Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency by Collignon, Olivier, Koenig, Franz, Koch, Armin, Hemmings, Robert James, Pétavy, Frank, Saint-Raymond, Agnès, Papaluca-Amati, Marisa, Posch, Martin

“…In recent years, experience on the application of adaptive designs in confirmatory clinical trials has accumulated. Although planning such trials comes at the…”
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Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study by Ureña-Torres, Pablo A, Floege, Jürgen, Hawley, Carmel M, Pedagogos, Eugenie, Goodman, William G, Pétavy, Frank, Reiner, Maureen, Raggi, Paolo

“…The ADVANCE study assessed the progression of vascular and cardiac valve calcification in 360 hemodialysis patients with secondary hyperparathyroidism (sHPT)…”
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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 carcinoma by Wülfing, Christian, Machiels, Jean‐Pascal H., Richel, Dirk J., Grimm, Marc‐Oliver, Treiber, Uwe, De Groot, Marco R., Beuzeboc, Philippe, Parikh, Roma, Pétavy, Frank, El‐Hariry, Iman A.

“…BACKGROUND: The treatment of recurrent transitional cell carcinoma (TCC) remains an unmet clinical need. This study assessed lapatinib, a dual tyrosine kinase…”
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The inhaled phosphodiesterase 4 inhibitor GSK256066 reduces allergen challenge responses in asthma by Singh, Dave, Petavy, Frank, Macdonald, Alex J, Lazaar, Aili L, O'Connor, Brian J

“…GSK256066 is a selective phosphodiesterase 4 inhibitor that can be given by inhalation, minimising the potential for side effects. We evaluated the effects of…”
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Quantitative Power Doppler Ultrasonography Is a Sensitive Measure of Metacarpophalangeal Joint Synovial Vascularity in Rheumatoid Arthritis and Declines Significantly Following a 2-week Course of Oral Low-dose Corticosteroids by LARCHE, Maggie J, SEYMOUR, Matthew, DOLAN, Kathleen, TAYLOR, Peter C, LIM, Adrian, ECKERSLEY, Robert J, PETAVY, Frank, CHIESA, Flaminia, RIOJA, Inmaculada, LUKEY, Pauline T, BINKS, Michael, MCCLINTON, Catherine

“…To investigate the stability over 2 weeks of ultrasonographic assessments of synovial thickness and vascularity in all 10 metacarpophalangeal joints of…”
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Access to Patient-Level Trial Data — A Boon to Drug Developers by Eichler, Hans-Georg, Pétavy, Frank, Pignatti, Francesco, Rasi, Guido

“…The European Medicines Agency aims to make patient-level data from clinical trials publicly accessible while protecting privacy; this would improve…”
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Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective by Butlen-Ducuing, Florence, Pétavy, Frank, Guizzaro, Lorenzo, Zienowicz, Malgorzata, Salmonson, Tomas, Haas, Manuel, Corruble, Emmanuelle, Alteri, Enrica

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Effective use of cinacalcet for the treatment of secondary hyperparathyroidism in Austrian dialysis patients – Results of the Austrian cohort of the ECHO study by Zitt, Emanuel, Jäger, Christine, Rosenkranz, Alexander R., Eigner, Manfred, Kodras, Katharina, Kovarik, Josef, Graf, Helmut, Pétavy, Frank, Horn, Sabine, Watschinger, Bruno

“…Summary BACKGROUND: Despite extensive use of standard therapy for secondary hyperparathyroidism (sHPT) in dialysis patients, still most patients do not achieve…”
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Rethinking the intention-to-treat principle: one size does not fit all by Oude Rengerink, Katrien, Mitroiu, Marian, Teerenstra, Steven, Pétavy, Frank, Roes, Kit Christian Bernardo

“…Adoption of the estimands framework by regulatory authorities and the pharmaceutical industry is expected to lead to global changes in trial design, trial…”
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Estimation of treatment effects in short‐term depression studies. An evaluation based on the ICH E9(R1) estimands framework by Mitroiu, Marian, Teerenstra, Steven, Oude Rengerink, Katrien, Pétavy, Frank, Roes, Kit C. B.

“…Estimands aim to incorporate intercurrent events in design, data collection and estimation of treatment effects in clinical trials. Our aim was to understand…”
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The changing landscape of data monitoring committees—Perspectives from regulators, members, and sponsors by Bhattacharyya, Amit, Gallo, Paul, Crisp, Adam, LaVange, Lisa, Molenberghs, Geert, Pétavy, Frank, Seltzer, Jonathan

“…Data Monitoring Committees (DMCs) are an integral part of clinical drug development. Their use has evolved along with changing study designs and regulatory…”
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Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey by Facile, Rhonda, Muhlbradt, Erin Elizabeth, Gong, Mengchun, Li, Qingna, Popat, Vaishali, Pétavy, Frank, Cornet, Ronald, Ruan, Yaoping, Koide, Daisuke, Saito, Toshiki I, Hume, Sam, Rockhold, Frank, Bao, Wenjun, Dubman, Sue, Jauregui Wurst, Barbara

“…Real-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage…”
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Lapatinib Versus Hormone Therapy in Patients With Advanced Renal Cell Carcinoma: A Randomized Phase III Clinical Trial by RAVAUD, Alain, HAWKINS, Robert, GORE, Martin, SCHÖFFSKI, Patrick, EL-HARIRY, Iman, GARDNER, Jason P, VON DER MAASE, Hans, ZANTL, Niko, HARPER, Peter, ROLLAND, Frédéric, AUDHUY, Bruno, MACHIELS, Jean-Pascal, PETAVY, Frank

“…Lapatinib is an orally reversible inhibitor of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER-2) tyrosine kinases with…”
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Presence of valvular calcification predicts the response to cinacalcet: data from the ADVANCE study by Bellasi, Antonio, Reiner, Maureen, Pétavy, Frank, Goodman, William, Floege, Juergen, Raggi, Paolo

“…Cardiac valve calcification (CVC) and coronary artery calcification (CAC) appear to be linked pathogenetically, and both are associated with a poor prognosis…”
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EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B‐Cell Lymphoma by Papadouli, Irene, Mueller‐Berghaus, Jan, Beuneu, Claire, Ali, Sahra, Hofner, Benjamin, Petavy, Frank, Tzogani, Kyriaki, Miermont, Anne, Norga, Koenraad, Kholmanskikh, Olga, Leest, Tim, Schuessler‐Lenz, Martina, Salmonson, Tomas, Gisselbrecht, Christian, Garcia, Jordi Llinares, Pignatti, Francesco

“…On June 28, 2018, the Committee for Advanced Therapies and the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the…”
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