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

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.

J Nutr Health Aging. 2013 Jul;17(7):612-8. doi: 10.1007/s12603-013-0362-7.


Prevention trials in Alzheimer's disease: an EU-US task force report.

Vellas B, Aisen PS, Sampaio C, Carrillo M, Scheltens P, Scherrer B, Frisoni GB, Weiner M, Schneider L, Gauthier S, Gispen-de Wied CC, Hendrix S, Feldman H, Cedarbaum J, Petersen R, Siemers E, Andrieu S, Prvulovic D, Touchon J, Hampel H.

Prog Neurobiol. 2011 Dec;95(4):594-600. doi: 10.1016/j.pneurobio.2011.08.014. Epub 2011 Sep 10.


Clinical trials on sarcopenia: methodological issues regarding phase 3 trials.

Abellan van Kan G, Cameron Chumlea W, Gillette-Guyonet S, Houles M, Dupuy C, Rolland Y, Vellas B.

Clin Geriatr Med. 2011 Aug;27(3):471-82. doi: 10.1016/j.cger.2011.03.010. Epub 2011 Jun 8. Review.


Carla Task Force on Sarcopenia: propositions for clinical trials.

Abellan van Kan G, André E, Bischoff Ferrari HA, Boirie Y, Onder G, Pahor M, Ritz P, Rolland Y, Sampaio C, Studenski S, Visser M, Vellas B.

J Nutr Health Aging. 2009 Oct;13(8):700-7.


Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: a consensus report.

Ferrucci L, Guralnik JM, Studenski S, Fried LP, Cutler GB Jr, Walston JD; Interventions on Frailty Working Group.

J Am Geriatr Soc. 2004 Apr;52(4):625-34. Review.


Guidance synthesis. Medical research for and with older people in Europe: proposed ethical guidance for good clinical practice: ethical considerations.

Diener L, Hugonot-Diener L, Alvino S, Baeyens JP, Bone MF, Chirita D, Husson JM, Maman M, Piette F, Tinker A, von Raison F; European Forum for Good Clinical Practice Geriatric Medicine Working Party.

J Nutr Health Aging. 2013 Jul;17(7):625-7. doi: 10.1007/s12603-013-0340-0.


Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations.

Hurria A, Dale W, Mooney M, Rowland JH, Ballman KV, Cohen HJ, Muss HB, Schilsky RL, Ferrell B, Extermann M, Schmader KE, Mohile SG; Cancer and Aging Research Group.

J Clin Oncol. 2014 Aug 20;32(24):2587-94. Review.


Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL.

Value Health. 2012 Mar-Apr;15(2):217-30. doi: 10.1016/j.jval.2011.12.010.


Therapeutic interventions for frail elderly patients: part I. Published randomized trials.

Bibas L, Levi M, Bendayan M, Mullie L, Forman DE, Afilalo J.

Prog Cardiovasc Dis. 2014 Sep-Oct;57(2):134-43. doi: 10.1016/j.pcad.2014.07.004. Epub 2014 Jul 22. Review.


Therapeutic interventions for frail elderly patients: part II. Ongoing and unpublished randomized trials.

Bendayan M, Bibas L, Levi M, Mullie L, Forman DE, Afilalo J.

Prog Cardiovasc Dis. 2014 Sep-Oct;57(2):144-51. doi: 10.1016/j.pcad.2014.07.005. Epub 2014 Jul 22. Review.


Biomarkers of sarcopenia in clinical trials-recommendations from the International Working Group on Sarcopenia.

Cesari M, Fielding RA, Pahor M, Goodpaster B, Hellerstein M, van Kan GA, Anker SD, Rutkove S, Vrijbloed JW, Isaac M, Rolland Y, M'rini C, Aubertin-Leheudre M, Cedarbaum JM, Zamboni M, Sieber CC, Laurent D, Evans WJ, Roubenoff R, Morley JE, Vellas B; International Working Group on Sarcopenia.

J Cachexia Sarcopenia Muscle. 2012 Sep;3(3):181-90. doi: 10.1007/s13539-012-0078-2. Epub 2012 Aug 3.


Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People.

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People.

Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.


Alzheimer's disease therapeutic trials: EU/US Task Force report on recruitment, retention, and methodology.

Vellas B, Hampel H, Rougé-Bugat ME, Grundman M, Andrieu S, Abu-Shakra S, Bateman R, Berman R, Black R, Carrillo M, Donohue M, Mintun M, Morris J, Petersen R, Thomas RG, Suhy J, Schneider L, Seely L, Tariot P, Touchon J, Weiner M, Sampaio C, Aisen P; Task Force Participants.

J Nutr Health Aging. 2012 Apr;16(4):339-45.


Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, Harris S.

Clin Trials. 2012 Dec;9(6):671-80. doi: 10.1177/1740774512461859.


An overview of the optimal planning, design, and conduct of phase I studies of new therapeutics.

LoRusso PM, Boerner SA, Seymour L.

Clin Cancer Res. 2010 Mar 15;16(6):1710-8. doi: 10.1158/1078-0432.CCR-09-1993. Epub 2010 Mar 9. Review.


Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.

Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E; ISPOR ePRO Task Force.

Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.


Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health.

Neaton JD, Babiker A, Bohnhorst M, Darbyshire J, Denning E, Frishman A, Grarup J, Larson G, Lundgren J.

Clin Trials. 2010 Dec;7(6):705-18. doi: 10.1177/1740774510376547. Epub 2010 Aug 20.


Antiphospholipid Syndrome Clinical Research Task Force report.

Erkan D, Derksen R, Levy R, Machin S, Ortel T, Pierangeli S, Roubey R, Lockshin M.

Lupus. 2011 Feb;20(2):219-24. doi: 10.1177/0961203310395053.

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