Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US Task Force recommendations.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Vellas, B; Pahor, M; Manini, T; Rooks, D; Guralnik, JM; Morley, J; Studenski, S; Evans, W; Asbrand, C; Fariello, R; Pereira, S; Rolland, Y; Abellan van Kan, G; Cesari, M; Chumlea, WC; Fielding, R

Published Date

  • July 2013

Published In

Volume / Issue

  • 17 / 7

Start / End Page

  • 612 - 618

PubMed ID

  • 23933872

Pubmed Central ID

  • PMC4077187

Electronic International Standard Serial Number (EISSN)

  • 1760-4788

Digital Object Identifier (DOI)

  • 10.1007/s12603-013-0362-7


  • eng

Conference Location

  • France