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Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement
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105citations -
Real-world and natural history data for drug evaluation in Duchenne muscular dystrophy: suitability of the North Star Ambulatory Assessment for comparisons with external controls
Francesco Muntoni A, James Signorovitch, Gautam Sajeev, Nathalie Goemans, Brenda L. Y. Wong, Cuixia Tian, +12 more
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FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective
Jane P. F. Bai, Brian James Schmidt, Kapil G. Gadkar, Valeriu Damian, Justin C. Earp, Christina M. Friedrich, +6 more
39citations -
Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?2021 Journal of Clinical Epidemiology article Mathematics Statistical Methods in Clinical Trials Open access
Rebecca Webster, Felicity L. Bishop, Professor Gary S. Collins, Andrea W.M. Evers, Tammy Hoffmann, J. André Knottnerus, +7 more
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A novel cardiovascular systems model to quantify drugs effects on the inter‐relationship between contractility and other hemodynamic variables2022 CPT Pharmacometrics & Systems Pharmacology article Mathematics Statistical Methods in Clinical Trials Open access
Yu Fu, Hadi Taghvafard, Medhat M. Said, Eric I. Rossman, Teresa A. Collins, Stéphanie Billiald‐Desquand, +4 more
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Histology independent drug development – Is this the future for cancer drugs?2023 Cancer Treatment Reviews article Mathematics Statistical Methods in Clinical Trials Open access
Lucinda Jane Billingham, Theodor Framke, Alastair Greystoke, Eivind J. Hovig, Philippe Page, Elias Péan, +4 more
6citations -
Comparisons of basic target-mediated drug disposition (TMDD) and ligand facilitated target removal (LFTR)2021 European Journal of Pharmaceutical Sciences article Mathematics Statistical Methods in Clinical Trials Open access
Lambertus A. Peletier, Rasmus Jansson‐Löfmark, Johan Gabrielsson
6citations -
A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: A modified Delphi approach2022 British Journal of Clinical Pharmacology article Mathematics Statistical Methods in Clinical Trials Open access
Victoria Palin, Tjeerd Pieter van Staa, Stephanie Steels, Andrea B. Troxel, Rolf H. H. Groenwold, Thomas MacLennan MacDonald, +7 more
6citations