Skip to main content
SpringerLink
Log in

How to Get Older People Included in Clinical Studies

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

Abstract

Older people are systematically excluded from many clinical research studies. In this review, we examine the reasons for this state of affairs and summarise the current knowledge of strategies to increase the rate of participation of older people in clinical studies. Older people want to participate in clinical research and are driven by a mixture of altruism and self-interest. They are often excluded by overt age cut-offs or covert exclusions based on co-morbidity and frailty. Other barriers to participation include communication and cognitive difficulties, transport difficulties, low income and self-imposed agism. Possible strategies to improve recruitment of older people to clinical studies include abolishing age limits, reducing exclusion criteria, and allowing sufficient study time (to recruit and deal with older patients) and money (for reimbursement of their participation costs) in study protocols. Involving older people and their attending health professionals in the design of study protocols may also be helpful. Providing transportation, easy physical access to research institutions and use of personalised and face-to-face recruitment also pay dividends. A variety of recruitment methods have been found to be effective, but tailoring the strategy to the condition and population under study is necessary. Together, these strategies should improve the representation of older people in clinical research and ensure that the evidence base is relevant and useful to all those caring for 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

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

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Hutchins LF, Unger JM, Crowley JJ, et al. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 1999; 341: 2061–7

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  3. 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; 146: 250–7

    Article  PubMed  Google Scholar 

  4. Bandyopadhyay S, Bayer AJ, O’Mahony MS. Age and gender bias in statin trials. QJM 2001; 94: 127–32

    Article  PubMed  CAS  Google Scholar 

  5. Gill SS, Bronskill SE, Mamdani M, et al. Representation of patients with dementia in clinical trials of donepezil. Can J Clin Pharmacol 2004; 11: e274–85

    PubMed  Google Scholar 

  6. Schneider LS, Olin JT, Lyness SA, et al. Eligibility of Alzheimer’s disease clinic patients for clinical trials. J Am Geriatr Soc 1997; 45: 923–8

    PubMed  CAS  Google Scholar 

  7. Rochon PA, Fortin PR, Dear KB, et al. Reporting of age data in clinical trials of arthritis: deficiencies and solutions. Arch Intern Med 1993; 153: 243–8

    Article  PubMed  CAS  Google Scholar 

  8. Mitchell SL, Sullivan EA, Lipsitz LA. Exclusion of elderly subjects from clinical trials for Parkinson disease. Arch Neurol 1997; 54: 1393–8

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  10. Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports. BMJ 1997; 315: 1059

    Article  PubMed  CAS  Google Scholar 

  11. McMurdo ME, Witham MD, Gillespie ND. Including older people in clinical research. BMJ 2005; 331: 1036–7

    Article  PubMed  Google Scholar 

  12. Bartlett C, Doyal L, Ebrahim S, et al. The causes and effects of socio-demographic exclusions from clinical trials. Health Technol Assess 2005; 9: iii–x, 1

    PubMed  CAS  Google Scholar 

  13. Wei L, Ebrahim S, Bartlett C, et al. Statin use in the secondary prevention of coronary heart disease in primary care: cohort study and comparison of inclusion and outcome with patients in randomised trials. BMJ 2005; 330: 821

    Article  PubMed  Google Scholar 

  14. Witham MD, Gillespie ND, Struthers AD. Tolerability of spironolactone in patients with chronic heart failure: a cautionary message. Br J Clin Pharmacol 2004; 58: 554–7

    Article  PubMed  CAS  Google Scholar 

  15. Ferguson PR. Selecting participants when testing new drugs: the implications of age and gender discrimination. Med Leg J 2002; 70: 130–4

    Article  PubMed  Google Scholar 

  16. Peterson ED, Lytle BL, Biswas MS, et al. Willingness to participate in cardiac trials. Am J Geriatr Cardiol 2004; 13: 11–5

    Article  PubMed  Google Scholar 

  17. Comis RL, Miller JD, Aldige CR, et al. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 2003; 21: 830–5

    Article  PubMed  Google Scholar 

  18. Yuval R, Uziel K, Gordon N, et al. Perceived benefit after participating in positive or negative/neutral heart failure trials: the patients’ perspective. Eur J Heart Fail 2001; 3: 217–23

    Article  PubMed  CAS  Google Scholar 

  19. Schron EB, Wassertheil-Smoller S, Pressel S. Clinical trial participant satisfaction: survey of SHEP enrollees. SHEP Cooperative Research Group. Systolic Hypertension in the Elderly Program. J Am Geriatr Soc 1997; 45: 934–8

    PubMed  CAS  Google Scholar 

  20. Townsley CA, Chan KK, Pond GR, et al. Understanding the attitudes of the elderly towards enrolment into cancer clinical trials. BMC Cancer 2006; 6: 34

    Article  PubMed  Google Scholar 

  21. Lewis JH, Kilgore ML, Goldman DP, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 2003; 21: 1383–9

    Article  PubMed  Google Scholar 

  22. Avenell A, Grant AM, McGee M, et al. The effects of an open design on trial participant recruitment, compliance and retention: a randomized controlled trial comparison with a blinded, placebo-controlled design. Clin Trials 2004; 1: 490–8

    Article  PubMed  Google Scholar 

  23. Welton AJ, Vickers MR, Cooper JA, et al. Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study. BMJ 1999; 318: 1114–7

    Article  PubMed  CAS  Google Scholar 

  24. Whelton PK, Bahnson J, Appel LJ, et al. Recruitment in the Trial of Nonpharmacologic Intervention in the Elderly (TONE). J Am Geriatr Soc 1997; 45: 185–93

    PubMed  CAS  Google Scholar 

  25. Gorkin L, Schron EB, Handshaw K, et al. Clinical trial enrollers vs. nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project. Control Clin Trials 1996; 17: 46–59

    Article  PubMed  CAS  Google Scholar 

  26. Chang BH, Hendricks AM, Slawsky MT, et al. Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure. BMC Med Res Methodol 2004; 4: 8

    Article  PubMed  Google Scholar 

  27. Allsup SJ, Gosney MA. Difficulties of recruitment for a randomized controlled trial involving influenza vaccination in healthy older people. Gerontology 2002; 48: 170–3

    Article  PubMed  Google Scholar 

  28. Tolmie EP, Mungall MM, Louden G, et al. Understanding why older people participate in clinical trials: the experience of the Scottish PROSPER participants. Age Ageing 2004; 33: 374–8

    Article  PubMed  Google Scholar 

  29. Unson CG, Dunbar N, Curry L, et al. The effects of knowledge, attitudes, and significant others on decisions to enroll in a clinical trial on osteoporosis: implications for recruitment of older African-American women. J Natl Med Assoc 2001; 93: 392–401

    PubMed  CAS  Google Scholar 

  30. Mills N, Donovan JL, Smith M, et al. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Control Clin Trials 2003; 24: 272–82

    Article  PubMed  Google Scholar 

  31. Gross CP, Filardo G, Mayne ST, et al. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer 2005; 103: 483–91

    Article  PubMed  Google Scholar 

  32. Unger JM, Coltman CA Jr, Crowley JJ, et al. Impact of the year 2000 Medicare policy change on older patient enrollment to cancer clinical trials. J Clin Oncol 2006; 24: 141–4

    Article  PubMed  Google Scholar 

  33. Gross CP, Wong N, Dubin JA, et al. Enrollment of older persons in cancer trials after the medicare reimbursement policy change. Arch Intern Med 2005; 165: 1514–20

    Article  PubMed  Google Scholar 

  34. Gross CP, Herrin J, Wong N, et al. Enrolling older persons in cancer trials: the effect of sociodemographic, protocol, and recruitment center characteristics. J Clin Oncol 2005; 23: 4755–63

    Article  PubMed  Google Scholar 

  35. Hewison J, Haines A. Overcoming barriers to recruitment in health research. BMJ 2006; 333: 300–2

    Article  PubMed  Google Scholar 

  36. Crombie IK, Irvine L, McMurdo MET, et al. Overcoming barriers to recruitment in health research: concerns of potential participants need to be dealt with. BMJ 2006 Aug 19; 333(7564): 398

    Article  PubMed  Google Scholar 

  37. Street A, Strong J, Karp S. Improving patient recruitment to multicentre clinical trials: the case for employing a data manager in a district general hospital-based oncology centre. Clin Oncol (R Coll Radiol) 2001; 13: 38–43

    CAS  Google Scholar 

  38. Rahman M, Morita S, Fukui T, et al. Physicians’ reasons for not entering their patients in a randomized controlled trial in Japan. Tohoku J Exp Med 2004; 203: 105–9

    Article  PubMed  Google Scholar 

  39. Peto V, Coulter A, Bond A. Factors affecting general practitioners’ recruitment of patients into a prospective study. Fam Pract 1993; 10: 207–11

    Article  PubMed  CAS  Google Scholar 

  40. Ford ME, Havstad SL, Davis SD. A randomized trial of recruitment methods for older African American men in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Clin Trials 2004; 1: 343–51

    Article  PubMed  Google Scholar 

  41. Simpson NK, Johnson CC, Ogden SL, et al. Recruitment strategies in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: the first six years. Control Clin Trials 2000; 21(6 Suppl.): 356S–78S

    Article  PubMed  CAS  Google Scholar 

  42. Koops L, Lindley RI. Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ 2002; 325: 415

    Article  PubMed  Google Scholar 

  43. Unson CG, Ohannessian C, Kenyon L, et al. Strategies for enrolling diverse older women in an osteoporosis trial. J Aging Health 2004; 16: 669–87

    Article  PubMed  Google Scholar 

  44. Donovan J, Mills N, Smith M, et al. Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002; 325: 766–70

    Article  PubMed  Google Scholar 

  45. Cambron JA. Recruitment and accrual of women in a randomized controlled trial of spinal manipulation. J Manipulative Physiol Ther 2001; 24: 79–83

    Article  PubMed  CAS  Google Scholar 

  46. Adams J, Silverman M, Musa D, et al. Recruiting older adults for clinical trials. Control Clin Trials 1997; 18: 14–26

    Article  PubMed  CAS  Google Scholar 

  47. Haibert JA, Silagy CA, Finucane P, et al. Recruitment of older adults for a randomized, controlled trial of exercise advice in a general practice setting. J Am Geriatr Soc 1999; 47: 477–81

    Google Scholar 

  48. Groupp E, Haas M, Fairweather A, et al. Recruiting seniors with chronic low back pain for a randomized controlled trial of a self-management program. J Manipulative Physiol Ther 2005; 28: 97–102

    Article  PubMed  Google Scholar 

  49. Coleman EA, Tyll L, LaCroix AZ, et al. Recruiting African-American older adults for a community-based health promotion intervention: which strategies are effective? Am J Prev Med 1997; 13: 51–6

    PubMed  CAS  Google Scholar 

  50. Flicker L, Wark JD. Recruitment strategies for randomised clinical trials in elderly Australians. Med J Aust 1997; 167: 438–9

    PubMed  CAS  Google Scholar 

  51. Pressel S, Davis BR, Louis GT, et al. Participant recruitment in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Control Clin Trials 2001; 22: 674–86

    Article  PubMed  CAS  Google Scholar 

  52. Norton MC, Breitner JC, Welsh KA, et al. Characteristics of nonresponders in a community survey of the elderly. J Am Geriatr Soc 1994; 42: 1252–6

    PubMed  CAS  Google Scholar 

  53. Zhu K, Hunter S, Bernard LJ, et al. Recruiting elderly African-American women in cancer prevention and control studies: a multifaceted approach and its effectiveness. J Natl Med Assoc 2000; 92: 169–75

    PubMed  CAS  Google Scholar 

  54. Kushler MG, Davidson WS. Alternative modes of outreach: an experimental comparison. Gerontologist 1978; 18: 355–62

    Article  PubMed  CAS  Google Scholar 

  55. Sellors J, Cosby R, Trim K, et al. Recruiting family physicians and patients for a clinical trial: lessons learned. Fam Pract 2002; 19: 99–104

    Article  PubMed  Google Scholar 

  56. Silagy CA, Campion K, McNeil JJ, et al. Comparison of recruitment strategies for a large-scale clinical trial in the elderly. J Clin Epidemiol 1991; 44: 1105–14

    Article  PubMed  CAS  Google Scholar 

  57. Ory MG, Lipman PD, Karlen PL, et al. Recruitment of older participants in frailty/injury prevention studies. Prev Sci 2002; 3: 1–22

    Article  PubMed  Google Scholar 

  58. Donovan JL, Peters TJ, Noble S, et al. Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). J Clin Epidemiol 2003; 56: 605–9

    Article  PubMed  Google Scholar 

  59. Moorman PG, Newman B, Millikan RC, et al. Participation rates in a case-control study: the impact of age, race, and race of interviewer. Ann Epidemiol 1999; 9: 188–95

    Article  PubMed  CAS  Google Scholar 

  60. Levkoff S, Sanchez H. Lessons learned about minority recruitment and retention from the Centers on Minority Aging and Health Promotion. Gerontologist 2003; 43: 18–26

    Article  PubMed  Google Scholar 

  61. Gregson BA, Smith M, Lecouturier J, et al. Issues of recruitment and maintaining high response rates in a longitudinal study of older hospital patients in England: pathways through care study. J Epidemiol Community Health 1997; 51: 541–8

    Article  PubMed  CAS  Google Scholar 

  62. Brown DR, Topcu M. Willingness to participate in clinical treatment research among older African Americans and Whites. Gerontologist 2003; 43: 62–72

    Article  PubMed  Google Scholar 

  63. UK Office of National Statistics 1996 [online]. Available from URL: http://www.statistics.gov.uk/statbase/expodata/spreadsheets/d5047.xls [Accessed 2007 Mar 7]

Download references

Acknowledgements

No sources of funding were used to assist in the preparation of this article. The authors have no conflicts of interest that are directly relevant to the content of this article.

Author information

Authors and Affiliations

  1. Section of Ageing and Health, University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK

    Miles D. Witham &  Marion E. T. McMurdo

Authors
  1. Miles D. Witham
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marion E. T. McMurdo
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Marion E. T. McMurdo.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Witham, M.D., McMurdo, M.E.T. How to Get Older People Included in Clinical Studies. Drugs Aging 24, 187–196 (2007). https://doi.org/10.2165/00002512-200724030-00002

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00002512-200724030-00002

Keywords

Search

Navigation