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Volumn 58, Issue 9, 2010, Pages 1791-1796

Fighting against age discrimination in clinical trials

Author keywords

clinical trial; exclusion; geriatric medicine; older participant; regulatory agency

Indexed keywords

AGEISM; CLINICAL TRIAL; COMORBIDITY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMED CONSENT; OUTCOME ASSESSMENT; PATIENT SELECTION; REVIEW; AGING; CLINICAL TRIAL (TOPIC); GERIATRICS; LEGISLATION AND JURISPRUDENCE; MEDICAL ETHICS; MEDICAL SOCIETY; PREJUDICE; PROCEDURES; PSYCHOLOGY;

EID: 77956325385     PISSN: 00028614     EISSN: 15325415     Source Type: Journal    
DOI: 10.1111/j.1532-5415.2010.03032.x     Document Type: Review
Times cited : (168)

References (29)
  • 1
    • 84925570109 scopus 로고    scopus 로고
    • Food and Drug Administration. Guideline for the study of drugs likely to be used in the elderly. 1989. Available at. Accessed February 1, 2010.
    • Food and Drug Administration. Guideline for the study of drugs likely to be used in the elderly. 1989. Available at Accessed February 1, 2010.
  • 2
    • 84925566967 scopus 로고    scopus 로고
    • International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Studies in support of special populations: geriatric E7, 1994. Available at. Accessed February 1, 2010.
    • International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Studies in support of special populations: geriatric E7, 1994. Available at Accessed February 1, 2010.
  • 3
    • 84925570108 scopus 로고    scopus 로고
    • Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of "Geriatric Use" Subsection in the Labeling. Food and Drug Administration. Department of Health and Human services. Federal register 1997;62: 45313-45326. Available at. Accessed February 1, 2010.
    • Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of "Geriatric Use" Subsection in the Labeling. Food and Drug Administration. Department of Health and Human services. Federal register 1997;62: 45313-45326. Available at Accessed February 1, 2010.
  • 4
    • 84925566966 scopus 로고    scopus 로고
    • Adequacy of guidance on the Elderly regarding medicinal products for human use. Committee for human medicinal products (CHMP). Available at. Accessed February 1, 2010.
    • Adequacy of guidance on the Elderly regarding medicinal products for human use. Committee for human medicinal products (CHMP). Available at Accessed February 1, 2010.
  • 5
    • 33947498821 scopus 로고    scopus 로고
    • Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review
    • Van Spall HG, Toren A, Kiss A et al. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review. JAMA 2007 297 : 1233 1240.
    • (2007) JAMA , vol.297 , pp. 1233-1240
    • Van Spall, H.G.1    Toren, A.2    Kiss, A.3
  • 6
    • 13544258730 scopus 로고    scopus 로고
    • SENIORS Investigators. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)
    • Flather MD, Shibata MC, Coats AJ et al. SENIORS Investigators. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). Eur Heart J 2005 26 : 215 225.
    • (2005) Eur Heart J , vol.26 , pp. 215-225
    • Flather, M.D.1    Shibata, M.C.2    Coats, A.J.3
  • 7
    • 42949112210 scopus 로고    scopus 로고
    • Treatment of hypertension in patients 80 years of age or older
    • Beckett NS, Peters R, Fletcher AE et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008 358 : 1887 1898.
    • (2008) N Engl J Med , vol.358 , pp. 1887-1898
    • Beckett, N.S.1    Peters, R.2    Fletcher, A.E.3
  • 8
    • 0037833740 scopus 로고    scopus 로고
    • Patients with chronic heart failure encountered in daily clinical practice are different from the "typical" patient enrolled in therapeutic trials
    • Badano LP, Di Lenarda A, Bellotti P et al. Patients with chronic heart failure encountered in daily clinical practice are different from the "typical" patient enrolled in therapeutic trials. Ital Heart J 2003 4 : 84 91.
    • (2003) Ital Heart J , vol.4 , pp. 84-91
    • Badano, L.P.1    Di Lenarda, A.2    Bellotti, P.3
  • 9
    • 0042991391 scopus 로고    scopus 로고
    • Most hospitalized older persons do not meet the enrolment criteria for clinical trials in heart failure
    • Masoudi FA, Havranek EP, Wolfe P et al. Most hospitalized older persons do not meet the enrolment criteria for clinical trials in heart failure. Am Heart J 2003 146 : 250 257.
    • (2003) Am Heart J , vol.146 , pp. 250-257
    • Masoudi, F.A.1    Havranek, E.P.2    Wolfe, P.3
  • 10
    • 77954486060 scopus 로고    scopus 로고
    • Health care for older people in Italy: The U.L.I.S.S.E. project (Un Link Informatico sui Servizi Sanitari Esistenti per l'anziano - A computerized network on health care services for older people)
    • Lattanzio F, Mussi C, Scafato E et al. Health care for older people in Italy: The U.L.I.S.S.E. project (Un Link Informatico sui Servizi Sanitari Esistenti per l'anziano - A computerized network on health care services for older people). J Nutr Health Aging 2010 14 : 238 242.
    • (2010) J Nutr Health Aging , vol.14 , pp. 238-242
    • Lattanzio, F.1    Mussi, C.2    Scafato, E.3
  • 11
    • 19444366654 scopus 로고    scopus 로고
    • Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials
    • Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 2005 23 : 3112 3124.
    • (2005) J Clin Oncol , vol.23 , pp. 3112-3124
    • Townsley, C.A.1    Selby, R.2    Siu, L.L.3
  • 12
    • 66149192531 scopus 로고    scopus 로고
    • Current guidelines for using angiotensin-converting enzyme inhibitors and angiotensin II-receptor antagonists in chronic kidney disease: Is the evidence base relevant to older adults?
    • O'Hare AM, Kaufman JS, Covinsky KE et al. Current guidelines for using angiotensin-converting enzyme inhibitors and angiotensin II-receptor antagonists in chronic kidney disease: Is the evidence base relevant to older adults? Ann Intern Med 2009 150 : 717 724.
    • (2009) Ann Intern Med , vol.150 , pp. 717-724
    • O'Hare, A.M.1    Kaufman, J.S.2    Covinsky, K.E.3
  • 13
    • 33947369446 scopus 로고    scopus 로고
    • How to get older people included in clinical studies
    • Witham MD, McMurdo ME. How to get older people included in clinical studies. Drugs Aging 2007 24 : 187 196.
    • (2007) Drugs Aging , vol.24 , pp. 187-196
    • Witham, M.D.1    McMurdo, M.E.2
  • 14
    • 51249113421 scopus 로고    scopus 로고
    • Maximizing clinical research participation in vulnerable older persons: Identification of barriers and motivators
    • Marcantonio ER, Aneja J, Jones RN et al. Maximizing clinical research participation in vulnerable older persons: Identification of barriers and motivators. J Am Geriatr Soc 2008 56 : 1522 1527.
    • (2008) J Am Geriatr Soc , vol.56 , pp. 1522-1527
    • Marcantonio, E.R.1    Aneja, J.2    Jones, R.N.3
  • 15
    • 0025831464 scopus 로고
    • Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group
    • SHEP cooperative research group.
    • SHEP cooperative research group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA 1991 265 : 3255 3264.
    • (1991) JAMA , vol.265 , pp. 3255-3264
  • 16
    • 0343487983 scopus 로고    scopus 로고
    • The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension
    • The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. Lancet 1997 350 : 757 764.
    • (1997) Lancet , vol.350 , pp. 757-764
  • 17
    • 0033528524 scopus 로고    scopus 로고
    • Antihypertensive drugs in very old people: A subgroup meta-analysis of randomised controlled trials
    • Gueyffier F, Bulpitt C, Boissel JP et al. Antihypertensive drugs in very old people: A subgroup meta-analysis of randomised controlled trials. INDANA Group. Lancet 1999 353 : 793 796.
    • (1999) INDANA Group. Lancet , vol.353 , pp. 793-796
    • Gueyffier, F.1    Bulpitt, C.2    Boissel, J.P.3
  • 18
    • 10744233011 scopus 로고    scopus 로고
    • Hypertension in the Very Elderly Trial Working Group. Results of the pilot study for the Hypertension in the Very Elderly Trial
    • Bulpitt CJ, Beckett NS, Cooke J et al. Hypertension in the Very Elderly Trial Working Group. Results of the pilot study for the Hypertension in the Very Elderly Trial. J Hypertens 2003 21 : 2409 2417.
    • (2003) J Hypertens , vol.21 , pp. 2409-2417
    • Bulpitt, C.J.1    Beckett, N.S.2    Cooke, J.3
  • 19
    • 0041963049 scopus 로고    scopus 로고
    • Embracing complexity: A consideration of hypertension in the very old
    • Goodwin JS. Embracing complexity: A consideration of hypertension in the very old. J Gerontol A Biol Sci Med Sci 2003 58A : 653 658.
    • (2003) J Gerontol A Biol Sci Med Sci , vol.58 , pp. 653-658
    • Goodwin, J.S.1
  • 20
    • 0033517302 scopus 로고    scopus 로고
    • The effect of spironolactone on morbidity and mortality in patients with severe heart failure
    • Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999 341 : 709 717.
    • (1999) N Engl J Med , vol.341 , pp. 709-717
    • Pitt, B.1    Zannad, F.2    Remme, W.J.3
  • 21
    • 3442886513 scopus 로고    scopus 로고
    • Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study
    • Juurlink DN, Mamdani MM, Lee DS et al. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med 2004 351 : 543 551.
    • (2004) N Engl J Med , vol.351 , pp. 543-551
    • Juurlink, D.N.1    Mamdani, M.M.2    Lee, D.S.3
  • 22
    • 3442896492 scopus 로고    scopus 로고
    • Treatment of heart failure with spironolactone-trial and tribulations
    • McMurray JJ, O'Meara E. Treatment of heart failure with spironolactone-trial and tribulations. N Engl J Med 2004 351 : 526 528.
    • (2004) N Engl J Med , vol.351 , pp. 526-528
    • McMurray, J.J.1    O'Meara, E.2
  • 23
    • 74549114172 scopus 로고    scopus 로고
    • Prescribing optimal drug therapy for older people: Sending the right message: Comment on "impact of FDA black box advisory on antipsychotic medication use."
    • Rochon PA, Anderson GM. Prescribing optimal drug therapy for older people: Sending the right message: Comment on "impact of FDA black box advisory on antipsychotic medication use." Arch Intern Med 2010 170 : 103 106.
    • (2010) Arch Intern Med , vol.170 , pp. 103-106
    • Rochon, P.A.1    Anderson, G.M.2
  • 24
    • 1942455747 scopus 로고    scopus 로고
    • Informed consent for research participation in frail older persons
    • Barron JS, Duffey PL, Byrd LJ et al. Informed consent for research participation in frail older persons. Aging Clin Exp Res 2004 16 : 79 85.
    • (2004) Aging Clin Exp Res , vol.16 , pp. 79-85
    • Barron, J.S.1    Duffey, P.L.2    Byrd, L.J.3
  • 25
    • 19944412446 scopus 로고    scopus 로고
    • Potential pitfalls of disease-specific guidelines for patients with multiple conditions
    • Tinetti ME, Bogardus ST Jr., Agostini JV. Potential pitfalls of disease-specific guidelines for patients with multiple conditions. N Engl J Med 2004 351 : 2870 2874.
    • (2004) N Engl J Med , vol.351 , pp. 2870-2874
    • Tinetti, M.E.1    Bogardus, Jr.S.T.2    Agostini, J.V.3
  • 26
    • 1842784019 scopus 로고    scopus 로고
    • Interventions on Frailty Working Group. 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 et al. Interventions on Frailty Working Group. Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: A consensus report. J Am Geriatr Soc 2004 52 : 625 634.
    • (2004) J Am Geriatr Soc , vol.52 , pp. 625-634
    • Ferrucci, L.1    Guralnik, J.M.2    Studenski, S.3
  • 27
    • 42449130997 scopus 로고    scopus 로고
    • Functional outcomes for clinical trials in frail older persons: Time to be moving
    • Working Group on Functional Outcome Measures for Clinical Trials.
    • Working Group on Functional Outcome Measures for Clinical Trials. Functional outcomes for clinical trials in frail older persons: Time to be moving. J Gerontol A Biol Sci Med Sci 2008 63 : 160 164.
    • (2008) J Gerontol A Biol Sci Med Sci , vol.63 , pp. 160-164
  • 28
    • 84925563830 scopus 로고    scopus 로고
    • Clinical Trial Transformation Initiative. Available at. Accessed February 1, 2010.
    • Clinical Trial Transformation Initiative. Available at Accessed February 1, 2010.
  • 29
    • 84925566965 scopus 로고    scopus 로고
    • Directive 2001/20/EC "Clinical Trials Directive" Protection of public health and rights and integrity of research participants; applies to Phases I-IV of clinical research, to all (investigational) medicinal products, to both industry sponsored and academic clinical research. Available at. Accessed February 1, 2010.
    • Directive 2001/20/EC "Clinical Trials Directive" Protection of public health and rights and integrity of research participants; applies to Phases I-IV of clinical research, to all (investigational) medicinal products, to both industry sponsored and academic clinical research. Available at Accessed February 1, 2010.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.