Search Results - "ZOHAR, Sarah"

An adaptive power prior for sequential clinical trials – Application to bridging studies by Ollier, Adrien, Morita, Satoshi, Ursino, Moreno, Zohar, Sarah

“…During drug evaluation trials, information from clinical trials previously conducted on another population, indications or schedules may be available. In these…”
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Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO): an open-label, dose finding, and feasibility phase 1/2 trial by Pressler, Ronit M, PhD, Boylan, Geraldine B, Prof, Marlow, Neil, Prof, Blennow, Mats, Prof, Chiron, Catherine, PhD, Cross, J Helen, Prof, de Vries, Linda S, Prof, Hallberg, Boubou, PhD, Hellström-Westas, Lena, Prof, Jullien, Vincent, PhD, Livingstone, Vicki, PhD, Mangum, Barry, PharmD, Murphy, Brendan, MD, Murray, Deirdre, PhD, Pons, Gerard, PhD, Rennie, Janet, MD, Swarte, Renate, PhD, Toet, Mona C, PhD, Vanhatalo, Sampsa, PhD, Zohar, Sarah, PhD

“…Summary Background Preclinical data suggest that the loop-diuretic bumetanide might be an effective treatment for neonatal seizures. We aimed to assess dose…”
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Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by interval debulking surgery in advanced ovarian cancer: Results from the ANTHALYA trial by Rouzier, Roman, Gouy, Sébastien, Selle, Frédéric, Lambaudie, Eric, Floquet, Anne, Fourchotte, Virginie, Pomel, Christophe, Colombo, Pierre-Emmanuel, Kalbacher, Elsa, Martin-Francoise, Sandrine, Fauvet, Raffaele, Follana, Philippe, Lesoin, Anne, Lecuru, Fabrice, Ghazi, Youssef, Dupin, Julien, Chereau, Elisabeth, Zohar, Sarah, Cottu, Paul, Joly, Florence

“…Abstract Aim To investigate whether adding bevacizumab to neoadjuvant carboplatin-paclitaxel (CP) helps achieve optimal debulking, measured by complete…”
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Phase I/II dose-finding design for molecularly targeted agent: Plateau determination using adaptive randomization by Riviere, Marie-Karelle, Yuan, Ying, Jourdan, Jacques-Henri, Dubois, Frédéric, Zohar, Sarah

“…Conventionally, phase I dose-finding trials aim to determine the maximum tolerated dose of a new drug under the assumption that both toxicity and efficacy…”
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A Bayesian non-inferiority approach using experts' margin elicitation - application to the monitoring of safety events by Aupiais, Camille, Alberti, Corinne, Schmitz, Thomas, Baud, Olivier, Ursino, Moreno, Zohar, Sarah

“…When conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the…”
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An extension of Bayesian predictive sample size selection designs for monitoring efficacy and safety by Teramukai, Satoshi, Daimon, Takashi, Zohar, Sarah

“…Most exploratory clinical trials in cancer are designed as single‐arm trials using a binary efficacy outcome with or without interim monitoring. In this…”
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Bayesian variable selection based on clinical relevance weights in small sample studies—Application to colon cancer by Boulet, Sandrine, Ursino, Moreno, Thall, Peter, Jannot, Anne‐Sophie, Zohar, Sarah

“…Using clinical data to model the medical decisions behind sequential treatment actions raises methodological challenges. Physicians often have access to many…”
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Determination of the optimal sample size for a clinical trial accounting for the population size by Stallard, Nigel, Miller, Frank, Day, Simon, Hee, Siew Wan, Madan, Jason, Zohar, Sarah, Posch, Martin

“…The problem of choosing a sample size for a clinical trial is a very common one. In some settings, such as rare diseases or other small populations, the large…”
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Recent advances in methodology for clinical trials in small populations: the InSPiRe project by Friede, Tim, Posch, Martin, Zohar, Sarah, Alberti, Corinne, Benda, Norbert, Comets, Emmanuelle, Day, Simon, Dmitrienko, Alex, Graf, Alexandra, Günhan, Burak Kürsad, Hee, Siew Wan, Lentz, Frederike, Madan, Jason, Miller, Frank, Ondra, Thomas, Pearce, Michael, Röver, Christian, Toumazi, Artemis, Unkel, Steffen, Ursino, Moreno, Wassmer, Gernot, Stallard, Nigel

“…Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including…”
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Bayesian sample size determination for phase IIA clinical trials using historical data and semi‐parametric prior's elicitation by Berchialla, Paola, Zohar, Sarah, Baldi, Ileana

“…Summary The Simon's two‐stage design is the most commonly applied among multi‐stage designs in phase IIA clinical trials. It combines the sample sizes at the…”
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A Bayesian dose-finding design for drug combination clinical trials based on the logistic model by Riviere, Marie-Karelle, Yuan, Ying, Dubois, Frédéric, Zohar, Sarah

“…In early phase dose‐finding cancer studies, the objective is to determine the maximum tolerated dose, defined as the highest dose with an acceptable…”
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Dose-Finding Study of Omeprazole on Gastric pH in Neonates with Gastro-Esophageal Acid Reflux Using a Bayesian Sequential Approach by Kaguelidou, Florentia, Alberti, Corinne, Biran, Valerie, Bourdon, Olivier, Farnoux, Caroline, Zohar, Sarah, Jacqz-Aigrain, Evelyne

“…Proton pump inhibitors are frequently administered on clinical symptoms in neonates but benefit remains controversial. Clinical trials validating omeprazole…”
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Value of information methods to design a clinical trial in a small population to optimise a health economic utility function by Pearce, Michael, Hee, Siew Wan, Madan, Jason, Posch, Martin, Day, Simon, Miller, Frank, Zohar, Sarah, Stallard, Nigel

“…Most confirmatory randomised controlled clinical trials (RCTs) are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a…”
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Dose-finding designs using a novel quasi-continuous endpoint for multiple toxicities by Ezzalfani, Monia, Zohar, Sarah, Qin, Rui, Mandrekar, Sumithra J., Deley, Marie-Cécile Le

“…The aim of a phase I oncology trial is to identify a dose with an acceptable safety profile. Most phase I designs use the dose‐limiting toxicity, a binary…”
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A Bayesian predictive sample size selection design for single-arm exploratory clinical trials by Teramukai, Satoshi, Daimon, Takashi, Zohar, Sarah

“…The aim of an exploratory clinical trial is to determine whether a new intervention is promising for further testing in confirmatory clinical trials. Most…”
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Decision-theoretic designs for small trials and pilot studies: A review by Hee, Siew Wan, Hamborg, Thomas, Day, Simon, Madan, Jason, Miller, Frank, Posch, Martin, Zohar, Sarah, Stallard, Nigel

“…Pilot studies and other small clinical trials are often conducted but serve a variety of purposes and there is little consensus on their design. One paradigm…”
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Approaches to sample size calculation for clinical trials in rare diseases by Miller, Frank, Zohar, Sarah, Stallard, Nigel, Madan, Jason, Posch, Martin, Hee, Siew Wan, Pearce, Michael, Vågerö, Mårten, Day, Simon

“…We discuss 3 alternative approaches to sample size calculation: traditional sample size calculation based on power to show a statistically significant effect,…”
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An approach to meta-analysis of dose-finding studies by Zohar, Sarah, Katsahian, Sandrine, O'Quigley, John

“…The main goal of a Phase I dose‐finding study is the estimation of the maximal tolerated dose (MTD) from a set of available dose levels. For cytotoxic clinical…”
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Using the continual reassessment method to estimate the minimum effective dose in phase II dose-finding studies: a case study by Zohar, Sarah, Resche-Rigon, Matthieu, Chevret, Sylvie

“…Background The Continual Reassessment Method typically is presented as the method of choice for the purpose of dose-finding based on a toxicity scale in phase…”
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Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study by Chéreau, Elisabeth, Uzan, Catherine, Boutmy-Deslandes, Emmanuelle, Zohar, Sarah, Bézu, Corinne, Mazouni, Chafika, Garbay, Jean-Rémi, Daraï, Emile, Rouzier, Roman

“…The aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in…”
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