Skip to main content
SpringerLink
Log in

Exclusion of Older People from Clinical Trials

Professional Views from Nine European Countries Participating in the PREDICT Study

  • Original Research Article
  • Published:
Drugs & Aging Aims and scope Submit manuscript

Abstract

Background: There has been concern about under-representation of older people in clinical trials. The PREDICT study reported that older people and those with co-morbidity continue to be excluded unjustifiably from clinical trials. However, there is no information about differences of opinion on these issues between EU countries. The results of a survey of health-related professionals from nine EU countries that participated in the PREDICT study are presented in this study.

Objective: The aim of the study was to identify and examine any differences of opinion between EU countries on the inclusion of older patients in clinical trials.

Methods: A questionnaire using a Likert scale and free text was completed by 521 general practitioners, geriatricians, clinical researchers, ethicists, nurses and industry pharmacologists/pharmacists. The questions explored the impact of the present situation, possible reasons for under-representation and potential methods of improving participation. Countries participating were the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the UK.

Results: There was agreement that exclusion from clinical trials on age grounds alone was unjustified (87%) and that under-representation of older people in trials caused difficulties for prescribers (79%) and patients (73%). There were national differences between professionals. All but the Lithuanians believed that older people were disadvantaged because of under-representation. The Czech, Lithuanian and Romanian professionals felt that it was justified to have age limits based on co-morbidity (61–83%) and polypharmacy (63–85%). Romanians also thought that having age limits on trial participation was justified because of reduced life expectancy (62%) and physical disability (58%) in older people. All but the Romanian professionals felt that the present arrangements for clinical trials were satisfactory (62%). All but the Israelis (56%) and Lithuanians (70%) agreed that regulation of clinical trials needed alteration.

Conclusions: Although respondent selection bias cannot be excluded, the differences that emerged between countries may be the result of the political and healthcare-system differences between older and newer members of the EU. These differences may influence decision making about clinical trial regulations and practice in older people.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Fig. 1
Fig. 2

Similar content being viewed by others

Explore related subjects

Discover the latest articles, news and stories from top researchers in related subjects.

References

  1. Clarfield AM, Friedman R. Survey of the age structure of “age-relevant” articles in four general medical journals. J Am Geriatr Soc 1985 Nov; 33(11): 773–8

    PubMed  CAS  Google Scholar 

  2. Cherubini A, Del Signore S, Ouslander J, et al. Fighting against age discrimination in clinical trials. J Am Geriatr Soc 2010 Sep; 58(9): 1791–6

    Article  PubMed  Google Scholar 

  3. Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports. BMJ 1997 Oct 25; 315(7115): 1059

    Article  PubMed  CAS  Google Scholar 

  4. McMurdo MET, Witham MD, Gillespie ND. Including older people in clinical research. BMJ 2005 Nov 5; 331(7524): 1036–7

    Article  PubMed  Google Scholar 

  5. Bayer A, Tadd W. Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: descriptive study. BMJ 2000 Oct 21; 321(7267): 992–3

    Article  PubMed  CAS  Google Scholar 

  6. Cruz-Jentoft AJ, Gutiérrez B. Upper age limits in studies submitted to a research ethics committee. Aging Clin Exp Res 2010 Apr; 22(2): 175–8

    PubMed  Google Scholar 

  7. Beswick A, Dieppe P, Burke M, et al. Improving representation of older people in clinical trials: a PREDICT systematic review [abstract]. Eur J Public Health 2009 Nov 28; 19(Supp. 1): 201

    Google Scholar 

  8. Cherubini A, Oristrell J, Pla X, et al. The persistent exclusion of older subjects from ongoing clinical trials in heart failure. Arch Intern Med 2011 Mar 28; 171(6): 550–6

    Article  PubMed  Google Scholar 

  9. PREDICT [online]. Available from URL: http://www.predicteu.org/index.html [Accessed 2011 May 31]

  10. Fudge N, Wolfe CDA, McKevitt C. Involving older people in health research. Age Ageing 2007 Sep 1; 36(5): 492–500

    Article  PubMed  CAS  Google Scholar 

  11. Habicht DW, Witham MD, McMurdo ME. The under-representation of older people in clinical trials: barriers and potential solutions. J Nutr Health Aging 2008 Mar; 12(3): 194–6

    Article  PubMed  CAS  Google Scholar 

  12. Witham MD, McMurdo MET. How to get older people included in clinical studies. Drugs Aging 2007; 24(3): 187–96

    Article  PubMed  Google Scholar 

  13. Le Quintrec JL, Bussy C, Golmard JL, et al. Randomized controlled drug trials on very elderly subjects: descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adults. J Gerontol Series A Biol Sci Med Sci 2005; 60(3): 340–4

    Article  Google Scholar 

  14. Lee PY, Alexander KP, Hammill BG, et al. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA 2001 Aug 8; 286(6): 708–13

    Article  PubMed  CAS  Google Scholar 

  15. Masoudi FA, Havranek EP, Wolfe P, et al. Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure. Am Heart J 2003 Aug; 146(2): 250–7

    Article  PubMed  Google Scholar 

  16. 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 May 1; 23(13): 3112–24

    Article  PubMed  Google Scholar 

  17. Bartlam B, Lally F, Crome P, et al., The PREDICT Study. Patients and carers views of older people’s participation in clinical trials [abstract]. Age Ageing 2011; 40(Suppl. 1): i73

    Google Scholar 

  18. Bartlam B, Lally F, Crome P, et al., The PREDICT Study. Patients and carers views of older people’s participation in clinical trials [abstract]. European Geriatric Medicine 2010; 1(S1): S1

    Google Scholar 

  19. EUGMS Policy Working Group. European Commission pharmaceutical package [online]. Available from URL: http://wwweugmsorg/indexphp?pid=1622009 [Accessed 2010 Jul 23]

  20. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Final concept paper E7(R1). Studies in support of special populations: geriatrics [online]. Available from URL: http://wwwichorg/LOB/media/MEDIA4930pdf2010 [Accessed 2010 Aug 23]

  21. European Forum on Good Clinical Practice. Ethical challenges in clinical research at both ends of life [online]. Available from URL: http://wwwefgcpeu/Downloads/confDocuments/Final%20Report%20-%20EFGCP-EUCROF%20Workshop%20Apr2010pdf 2010 [Accessed 2010 Aug 23]

Download references

Acknowledgements

This study was supported by EU grant number HEALTH-F4-2008-201917. The sponsor’s roles were to ensure targets were met and funding was correctly allocated. The authors have no conflicts of interest that are directly relevant to the content of this study.

Author information

Authors and Affiliations

  1. Institute for Life Course Studies, Keele University, Keele, Staffordshire, UK

    Peter Crome & Frank Lally

  2. Department of Clinical and Experimental Medicine, Institute of Geriatrics and Gerontology, University of Perugia Medical School, Perugia, Italy

    Antonio Cherubini

  3. Department of Internal Medicine and Geriatrics, Universitat Autònoma de Barcelona, Hospital de Sabadell, Corporació Parc Taulí, Barcelona, Spain

    Joaquim Oristrell

  4. Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Bristol, UK

    Andrew D. Beswick

  5. Department of Geriatrics, Soroka Hospital and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel

    A. Mark Clarfield

  6. Department of Nursing Home Medicine, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands

    Cees Hertogh

  7. Geriatric Clinic, Kaunas University of Medicine, Kaunas, Lithuania

    Vita Lesauskaite

  8. Ana Aslan National Institute of Geriatrics and Gerontology, Bucharest, Romania

    Gabriel I. Prada

  9. Institute of Public Health, Jagiellonian University Medical College, Krakow, Poland

    Katarzyna Szczerbińska

  10. Department of Geriatrics, First Faculty of Medicine, Charles University, Prague, Czech Republic

    Eva Topinkova

  11. Medical Economics and Research Centre Sheffield, Woodside, Rotherham General Hospital, Rotherham, UK

    Judith Sinclair-Cohen, David Edbrooke & Gary Mills

  12. Department of Critical Care and Anaesthesia, Sheffield Teaching Hospitals and Sheffield University, Sheffield, UK

    Gary Mills

Authors
  1. Peter Crome
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Frank Lally
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Antonio Cherubini
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Joaquim Oristrell
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Andrew D. Beswick
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. A. Mark Clarfield
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Cees Hertogh
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Vita Lesauskaite
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Gabriel I. Prada
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Katarzyna Szczerbińska
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Eva Topinkova
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Judith Sinclair-Cohen
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. David Edbrooke
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Gary Mills
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Peter Crome.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Crome, P., Lally, F., Cherubini, A. et al. Exclusion of Older People from Clinical Trials. Drugs Aging 28, 667–677 (2011). https://doi.org/10.2165/11591990-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11591990-000000000-00000

Keywords

Search

Navigation