Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US Task Force recommendations.
An international task force of academic and industry leaders in sarcopenia research met on December 5, 2012 in Orlando, Florida to develop guidelines for designing and executing randomized clinical trials of sarcopenia treatments. The Task Force reviewed results from previous trials in related disease areas to extract lessons relevant to future sarcopenia trials, including practical issues regarding the design and conduct of trials in elderly populations, the definition of appropriate target populations, and the selection of screening tools, outcome measures, and biomarkers. They discussed regulatory issues, the challenges posed by trials of different types of interventions, and the need for standardization and harmonization. The Task Force concluded with recommendations for advancing the field toward better clinical trials.
University of Toulouse III, Toulouse, France.
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Vellas
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Pahor
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Manini
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Rooks
J M
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Guralnik
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Morley
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Studenski
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W
Evans
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Asbrand
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Fariello
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Pereira
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Rolland
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Abellan van Kan
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Cesari
Wm C
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Chumlea
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Fielding
D026683:Advisory Committees; D000368:Aged; D000369:Aged, 80 and over; D003226:Congresses as Topic; D005062:European Union; D016330:Frail Elderly; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D055948:Sarcopenia / Q000188:drug therapy*; D014481:United States