DELTA (Difference ELicitation in TriAls)2 advice and recommendations for researchers and funder representatives – output from literature reviews, Delphi study, workshop and stakeholder engagement

Autor: Cook, J, Julious, SA, Sones, W, Hampson, LV, Hewitt, C, Berlin, JA, Ashby, D, Emsley, R, Fergusson, DA, Walters, SJ, Wilson, ECF, Maclennan, GS, Stallard, N, Rothwell, JC, Bland, M, Brown, L, Ramsay, CR, Cook, A, Armstrong, D, Altman, D, Vale, LD

Publikováno v: Health Technology Assessment.

Background The randomised controlled trial (RCT) is widely considered to be the gold standard study for comparing the effectiveness of health interventions. Central to its design is a calculation of the number of participants needed (the sample size)

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Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma.

Autor: Hao Y; Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA.; Current affiliation: Gilead Sciences, Foster City, CA 94404, USA., Hsu WC; Genesis Research, Hoboken, NJ 07030, USA., Parzynski CS; Genesis Research, Hoboken, NJ 07030, USA., Degtyarev E; Novartis Pharma AG, CH-4056, Basel, Switzerland., Hampson LV; Novartis Pharma AG, CH-4056, Basel, Switzerland., Masood A; Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA., Wu WH; Genesis Research, Hoboken, NJ 07030, USA.

Publikováno v: Journal of comparative effectiveness research [J Comp Eff Res] 2023 Jul; Vol. 12 (7), pp. e220173. Date of Electronic Publication: 2023 Jun 22.

A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials.

Autor: Hampson LV; Novartis Pharma AG, Basel, Switzerland., Holzhauer B; Novartis Pharma AG, Basel, Switzerland., Bornkamp B; Novartis Pharma AG, Basel, Switzerland., Kahn J; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA., Lange MR; Novartis Pharma AG, Basel, Switzerland., Luo WL; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA., Singh P; Novartis Pharma AG, Basel, Switzerland., Ballerstedt S; Novartis Pharma AG, Basel, Switzerland., Cioppa GD; Clinical R&D Consultants srls, Rome, Italy.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2022 May; Vol. 111 (5), pp. 1050-1060. Date of Electronic Publication: 2021 Dec 13.

Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in Childhood Polyarteritis Nodosa: An Open-Label, Randomized, Bayesian Noninferiority Trial.

Autor: Brogan PA; University College London Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Arch B; University of Liverpool, Liverpool, UK., Hickey H; University of Liverpool, Liverpool, UK., Anton J; St. Joan de Déu Hospital, Barcelona, Spain., Iglesias E; St. Joan de Déu Hospital, Barcelona, Spain., Baildam E; Alder Hey Children's NHS Foundation Trust, Liverpool, UK., Mahmood K; Alder Hey Children's NHS Foundation Trust, Liverpool, UK., Cleary G; Alder Hey Children's NHS Foundation Trust, Liverpool, UK., Moraitis E; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Papadopoulou C; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Beresford MW; University of Liverpool, Liverpool, UK., Riley P; Royal Manchester Children's Hospital, Manchester, UK., Demir S; Hacettepe University, Ankara, Turkey., Ozen S; Hacettepe University, Ankara, Turkey., Culeddu G; Bangor University, Bangor, UK., Hughes DA; Bangor University, Bangor, UK., Dolezalova P; General University Hospital in Prague and Charles University, Prague, Czech Republic., Hampson LV; Lancaster University, Lancaster, UK., Whitehead J; Lancaster University, Lancaster, UK., Jayne D; University of Cambridge, Cambridge, UK., Ruperto N; Instituto Giannina Gaslini, IRCCS, UOSID Centro Trial, Genoa, Italy., Tudur-Smith C; University of Liverpool, Liverpool, UK., Eleftheriou D; University College London Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.

Publikováno v: Arthritis & rheumatology (Hoboken, N.J.) [Arthritis Rheumatol] 2021 Sep; Vol. 73 (9), pp. 1673-1682. Date of Electronic Publication: 2021 Jul 31.

Bridging across patient subgroups in phase I oncology trials that incorporate animal data.

Autor: Zheng H; Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.; Department of Mathematics and Statistics, Lancaster University, Lancashire, UK., Hampson LV; Advanced Methodology and Data Science, Novartis Pharma AG, Basel, Switzerland., Jaki T; Department of Mathematics and Statistics, Lancaster University, Lancashire, UK.; MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.

Publikováno v: Statistical methods in medical research [Stat Methods Med Res] 2021 Apr; Vol. 30 (4), pp. 1057-1071. Date of Electronic Publication: 2021 Jan 27.