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Exclusion of Older People from Clinical Trials

Professional Views from Nine European Countries Participating in the PREDICT Study

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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.

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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.

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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

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  1. Peter Crome
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  2. Frank Lally
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  3. Antonio Cherubini
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  4. Joaquim Oristrell
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  5. Andrew D. Beswick
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  6. A. Mark Clarfield
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  7. Cees Hertogh
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  8. Vita Lesauskaite
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  9. Gabriel I. Prada
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  10. Katarzyna Szczerbińska
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  11. Eva Topinkova
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  12. Judith Sinclair-Cohen
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  13. David Edbrooke
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  14. Gary Mills
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Correspondence to Peter Crome.

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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

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