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Fighting Against Age Discrimination in Clinical Trials

Authors

  • Antonio Cherubini MD, PhD,

    1. From the *Institute of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Perugia, Italy; Sanofi-Aventis Recherché & Développement, Massy, France; Division of Gerontology and Geriatric Medicine, Miller School of Medicine, University of Miami, Miami, Florida; §Pharmacy Benefit Management Services, U.S. Department of Veterans Affairs, Washington, District of Columbia; Division of Geriatric Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; and #Department of Rehabilitation and Geriatrics, Geneva Medical School and University Hospitals, Geneva, Switzerland.
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  • Susanna Del Signore MD,

    1. From the *Institute of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Perugia, Italy; Sanofi-Aventis Recherché & Développement, Massy, France; Division of Gerontology and Geriatric Medicine, Miller School of Medicine, University of Miami, Miami, Florida; §Pharmacy Benefit Management Services, U.S. Department of Veterans Affairs, Washington, District of Columbia; Division of Geriatric Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; and #Department of Rehabilitation and Geriatrics, Geneva Medical School and University Hospitals, Geneva, Switzerland.
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  • Joe Ouslander MD,

    1. From the *Institute of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Perugia, Italy; Sanofi-Aventis Recherché & Développement, Massy, France; Division of Gerontology and Geriatric Medicine, Miller School of Medicine, University of Miami, Miami, Florida; §Pharmacy Benefit Management Services, U.S. Department of Veterans Affairs, Washington, District of Columbia; Division of Geriatric Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; and #Department of Rehabilitation and Geriatrics, Geneva Medical School and University Hospitals, Geneva, Switzerland.
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  • Todd Semla MS, PharmD,

    1. From the *Institute of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Perugia, Italy; Sanofi-Aventis Recherché & Développement, Massy, France; Division of Gerontology and Geriatric Medicine, Miller School of Medicine, University of Miami, Miami, Florida; §Pharmacy Benefit Management Services, U.S. Department of Veterans Affairs, Washington, District of Columbia; Division of Geriatric Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; and #Department of Rehabilitation and Geriatrics, Geneva Medical School and University Hospitals, Geneva, Switzerland.
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  • Jean-Pierre Michel MD

    1. From the *Institute of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Perugia, Italy; Sanofi-Aventis Recherché & Développement, Massy, France; Division of Gerontology and Geriatric Medicine, Miller School of Medicine, University of Miami, Miami, Florida; §Pharmacy Benefit Management Services, U.S. Department of Veterans Affairs, Washington, District of Columbia; Division of Geriatric Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; and #Department of Rehabilitation and Geriatrics, Geneva Medical School and University Hospitals, Geneva, Switzerland.
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  • At the time of this roundtable, Antonio Cherubini was a member of the Executive Board of the European Union Geriatric Medicine Society (EUGMS); Susanna Del Signore was CNS Specialised Group Leader for Safety and Efficacy, Pre-Authorization Evaluation of Medicines for Human Use, European Medicine Agency; Todd Semla was President of the American Geriatrics Society; and Jean-Pierre Michel was Academic Director of the EUGMS.

Address correspondence to Antonio Cherubini, Associate Professor of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Piazzale Menghini 1, 06156 Perugia, Italy. E-mail: cherubin_9@yahoo.com

Abstract

At the American Geriatrics Society 2008 Annual Meeting, representatives of two geriatric societies, the European Union Geriatric Medicine Societies and the American Geriatrics Society, and two regulatory agencies, the U.S. Food and Drug Administration and the European Medicine Agency, conducted a roundtable discussion aimed at reviewing the participation of older people in clinical trials. This article summarizes the important issues discussed at the meeting. Historically, regulatory agencies started to promote the inclusion of older participants in clinical trials in the late 1980s. The identification of the causes of delay in including older participants in clinical trials, as well as of the ongoing bias against including older participants with multiple comorbidities, is important to help geriatricians fight against age discrimination in clinical trials. To overcome this problem, geriatrics societies and regulatory agencies must work together to propose new definitions, study designs, and technologies aimed at improving the evaluation of drugs in older people with multiple comorbidities and polypharmacy.

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