Elderly patients' participation in clinical trials

Premnath Shenoy, Anand Harugeri, Premnath Shenoy, Anand Harugeri

Abstract

The elderly population is a large and the fastest-growing portion of the population worldwide. The elderly make up the lion's share of patients for certain health conditions including cancer, cardiovascular disease, arthritis, and Parkinson's disease, among others in most parts of the world. Furthermore, elderly make up the majority of patients for many medications treating chronic conditions. Typically, clinical trials conducted in adult population include patients between the ages of 18 and 64 years. However, drugs should be studied in all age groups and trial participants should be representative of the patient population receiving the therapy in daily medical practice. Elderly patients are poorly represented in clinical trials. Hence, there is inadequate evidence and knowledge about responses of geriatric patients to medications. Regulatory authorities in developed countries urge to avoid arbitrary upper age limits and advise researchers and industry not to exclude elderly people from clinical trials without a valid reason. Since last few years Indian regulatory authority has been stipulating upper age limit for studies conducted in India. The Central Drugs Standard Control Organization (CDSCO) will be doing a great contribution to the researchers if it changes its view on stipulating upper age restrictions in clinical studies. This article describes the need for including elderly patients in the clinical trials in order to garner data from geriatric patients who form major medication users in most of the chronic diseases.

Keywords: Clinical trial; India; drug regulations; elderly.

References

    1. Avorn J. Medication use and the elderly: Current status and opportunities. Health Aff (Millwood) 1995;14:276–86.
    1. Gad SC. Evaluation of human tolerance and safety in clinical studies: Phase I and beyond. In: Gad SC, editor. Drug Safety Evaluation. New York: John Wiley and Sons, Inc; 2002. pp. 764–830.
    1. United Nations. World Population Prospects: The 2010 Revision. [Last accessed on 2015 Apr 27]. Available from: .
    1. Mari Bhat PN. Demographic Scenario, 2025. Planning Commission, Government of India. [Last accessed on 2015 Apr 27]. Available from: .
    1. Zizza CA, Ellison KJ, Wernette CM. Total water intakes of community-living middle-old and oldest-old adults. J Gerontol A Biol Sci Med Sci. 2009;64:481–6.
    1. Harugeri A, Joseph J, Parthasarathi G, Ramesh M, Guido S. Potentially inappropriate medication use in elderly patients: A study of prevalence and predictors in two teaching hospitals. J Postgrad Med. 2010;56:186–91.
    1. McLean AJ, Le Couteur DG. Aging biology and geriatric clinical pharmacology. Pharmacol Rev. 2004;56:163–84.
    1. Davis D, Grossman SH, Kitchell BB, Shand DG, Routledge PA. The effects of age and smoking on the plasma protein binding of lignocaine and diazepam. Br J Clin Pharmacol. 1985;19:261–5.
    1. Grandison MK, Boudinot FD. Age-related changes in protein binding of drugs: Implications for therapy. Clin Pharmacokinet. 2000;38:271–90.
    1. Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21:1383–9.
    1. Hutchins LF, Unger JM, Crowley JJ, Coltman CA, Jr, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341:2061–7.
    1. Briggs R, Robinson S, O’Neill D. Ageism and clinical research. Ir Med J. 2012;105:311–2.
    1. Lazzarini V, Mentz RJ, Fiuzat M, Metra M, O’Connor CM. Heart failure in elderly patients: Distinctive features and unresolved issues. Eur J Heart Fail. 2013;15:717–23.
    1. Bartlam B, Lally F, Crome P. The PREDICT study: Increasing the Participation of the Elderly in Clinical Trials. The Opinions of Patients and Carers. Lay Report. Keele University. 2010
    1. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry. E7 Studies in Support of Special Populations: Geriatrics. Questions and Answers. 2012. [Last accessed on 2015 Apr 27]. Available from: .
    1. Talarico L, Chen G, Pazdur R. Enrollment of elderly patients in clinical trials for cancer drug registration: A 7-year experience by the US Food and Drug Administration. J Clin Oncol. 2004;22:4626–31.
    1. Yancik R, Ries LA. Aging and cancer in America. Demographic and epidemiologic perspectives. Hematol Oncol Clin North Am. 2000;14:17–23.
    1. Committee for Human Medicinal Products (CHMP). Adequacy of Guidance on the Elderly Regarding Medicinal Products for Human Use. European Medicines Agency. 2007. [Last accessed on 2015 Apr 20]. Available from: .
    1. Fahy N, McKee M, Busse R, Grundy E. How to meet the challenge of ageing populations. BMJ. 2011;342:d3815.
    1. Tri-Council Policy Statement. Fairness and Equity in Research Participation. [Last accessed on 2015 Apr 27]. Available from: .
    1. Ministry of Health and Family Welfare. Government of India. Drugs and Cosmetic Rules. 1945. [Last accessed on 2015 Apr 27]. Available from: .
    1. Gupta YK, Pradhan AK, Goyal A, Mohan P. Compensation for clinical trial-related injury and death in India: Challenges and the way forward. Drug Saf. 2014;37:995–1002.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する