Skip to main content
SpringerLink
Log in

Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation

  • Clinical Trials
  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

Subject retention is one of the key factors that determine success of a clinical trial. Many researchers have focused on the issue of recruitment, and few have focused on retention. Subjects discontinue from clinical trials for variety of reasons. Sociodemographic characteristics such as age, gender, race, employment, and level of education have been implicated as the most common influencers for participation in clinical trials. This study evaluated the influence of these sociodemographic characteristics on the risk of subject discontinuation. There was little apparent difference in the sociodemographic characteristics among completers and discontinued subjects. Importantly, it was noticed that there is no common format for reporting clinical trial sociodemographic characteristics, thus leading to difficulties in the interpretation of the influence of such factors on subject retention. Suggestions are provided for future researchers that would greatly enhance the prediction of sociodemographic influences on subject discontinuation. Strategies to overcome such influences may be required.

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.

Institutional subscriptions

Similar content being viewed by others

References

  1. Heskett K. Clinical trials: issues and resources. J Consumer Health Internet. 2004;8(3):35–52.

    Article  Google Scholar 

  2. Sullivan J. Subject recruitment and retention: barriers to success. 2004. https://doi.org/www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=89608.

  3. Connor SH. An integrated approach for clinical trial patient retention. 2010. https://doi.org/www.ngpharmasummit.com/media/whitepapers/Acurian_Retention_NGPUS.pdf.

  4. Elvidge S. The importance of patient retention strategies. Life Sci Leader. 2010. https://doi.org/www.lifescienceleader.com/magazine/past-issues3/item/3460-the-importance-of-patient-retention-strategies?list=n.

  5. Kittredge C. A shrinking target: clinical trials are taking longer, and costing more, as competition for patients’ heat up. Scientist-Philadelphia. 2005;19(7):46–49.

    Google Scholar 

  6. Kaitin K, ed. Growing protocol design complexity stresses investigators, volunteers. Tufts CSDD Impact Rep. 2008;10(1):1–4.

    Google Scholar 

  7. Getz K. Public confidence and trust today. Monitor 2008;(Sept): 8–21.

  8. Davis M, Addis M. Predictors of attrition from behavioral medicine treatments. Ann Behav Med. 1999;21:339–349.

    Article  CAS  Google Scholar 

  9. Frederick LG. Participant retention in clinical research: a major challenge. 2011. https://doi.org/www.healthsystem.virginia.edu/internet/ican/lgf_spring_08.doc.

  10. Good M, Schuler L. Subject retention in a controlled clinical trial. J Adv Nurs. 1997;26:351–355.

    Article  CAS  Google Scholar 

  11. Mor M, Niv G, Niv Y. Patient retention in a clinical trial: a lesson from the rofecoxib (VIOXX) study. Dig Dis Sci. 2006;51(7):1175–1178.

    Article  Google Scholar 

  12. Betz D, Betz D, Leahy D. Burden of patient dropouts and patients lost-to-follow-up on clinical studies. 2009. https://doi.org/www.lost-to-follow-up.com/faqs#q8.

  13. Hellard ME, Sinclair MI, Forbes AB, Fairley CK. Methods used to maintain a high level of participant involvement in a clinical trial. J Epidemiol Com Health. 2001;55:348–351.

    Article  CAS  Google Scholar 

  14. Kerr DJ, Knox K, Robertson DC, Stewart D, Watson R. Questions about clinical trials: a framework for discussion. In: Kerr DJ, Knox K, Robertson DC, Stewart D, Watson R, eds. Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals. Cambridge, MA: Blackwell; 2006:38–45.

    Chapter  Google Scholar 

  15. Morse EV, Simon PM, Besch CL, Walker J. Issues of recruitment, retention and compliance in community based clinical trials with traditionally underserved populations. Appl Nurs Res. 1995;8:8–14.

    Article  CAS  Google Scholar 

  16. Demi AS, Warren NA. Issues in conducting research with vulnerable families. West J Nurs Res. 1995;17:188–202.

    Article  CAS  Google Scholar 

  17. Given BA, Keilman LJ, Collins C, Given CW. Strategies to minimize attrition in longitudinal studies. Nurs Res. 1990;39:184–186.

    Article  CAS  Google Scholar 

  18. Wineman NM, Durand E. Incentives and rewards for subjects in nursing research. West J Nurs Res. 1992;14:526–531.

    Article  CAS  Google Scholar 

  19. Rudy EB, Estok PJ, Kerr ME, Menzel L. Research incentives: Money versus gifts. Nurs Res. 1994;43:253–255.

    Article  CAS  Google Scholar 

  20. Robinson S, Marsland L. Approaches to the problem of respondent attrition in a longitudinal panel study of nurses’ careers. J Adv Nurs. 1994;20:729–741.

    Article  CAS  Google Scholar 

  21. Beck CT. Subject mortality: is it inevitable? West J Nurs Res. 1984;6:331–339.

    Article  CAS  Google Scholar 

  22. Martin KM. Coordinating multidisciplinary collaborative research: a formula for success. Clin Nurs Specialist. 1994;8(1):18–22.

    Article  CAS  Google Scholar 

  23. Glasgow R, Nelson C, Kearney K et al. Reach, engagement and retention in an internet based weight loss program in a multisite randomized controlled trial. J Med Internet Res. 2007;9(e):11.

    Article  Google Scholar 

  24. Honas J, Early J, Frederickson D, O’Brien M. Predictors of attrition in a large clinic based weight-loss program. Obes Res. 2003;11:888–894.

    Article  Google Scholar 

  25. Janson S, Alioto M, Boushy H. Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial. Control Clin Trials. 2001;22:236S–43S.

    Article  CAS  Google Scholar 

  26. El-Khorazaty MN, Johnson A, Kiely M et al. Recruitment and retention of low-income minority women in a behavioral intervention to reduce smoking, depression, and intimate partner violence during pregnancy. BMC Public Health. 2007;7:233.

    Article  Google Scholar 

  27. Moser DK, Dracup K, Doering LV. Factors differentiating dropouts from completers in a longitudinal, multicenter clinical trial. Nurs Res. 2000;49(2):109–116.

    Article  CAS  Google Scholar 

  28. Kennedy B, Paeratakul S, Champane C, et al. A pilot church—based weight loss program for African American adults utilizing church members as health educators: a comparison of individual and group intervention. Ethnicity Dis. 2005;15:373–378.

    Google Scholar 

  29. Lopez-Goni JJ, Fernandez-Montalvo J, III Escas C, Landa N, Lorea I. Determining socio-demographic predictors of treatment dropout: results in a therapeutic community. Int J Soc Welfare. 2008;17:374–378.

    Article  Google Scholar 

  30. Larson EL, Ferng Y, McLoughlin J, Wang S. Retention and protocol adherence of Hispanic volunteers in a longitudinal trial. Am J Health Behav. 2009;33(4):435–444.

    Article  Google Scholar 

  31. Bender BG, Ikle DN, DuHamel T, Tinkelman D. Retention of asthmatic patients in a longitudinal clinical trial. J Allergy Clin Immunol. 1977;99(2):197–203.

    Article  Google Scholar 

  32. Sonawalla SB, Farabaugh AH, Leslie VM, Pava JA, Matthews JD, Fava M. Early drop-outs, late drop-outs and completers: differences in the continuation phase of a clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2002;26:415–419.

    Article  Google Scholar 

  33. Cramer JA, Collins JF, Mattson RH. Can categorization of patient background problems be used to determine early termination in a clinical trial? Control Clin Trials. 1988;9:47–63.

    Article  CAS  Google Scholar 

  34. Busnello RG, Melchior R, Faccin C et al. Characteristics associated with the dropout of hypertensive patients followed up in an outpatient referral clinic. Arq Bras Cardiol. 2001;76(5):352–354.

    Article  Google Scholar 

  35. Mattson P, Tomson T, Eriksson O. Socio-demographic differences in antiepileptic drug prescriptions to adult epilepsy patients. Am Acad Neurol. 2010;74:295–301.

    Google Scholar 

  36. King AC, Canada SA. Client-related predictors of early treatment drop-out in a substance abuse clinic exclusively employing individual therapy. J Subst Abuse Treatment. 2004;26:189–195.

    Article  Google Scholar 

  37. Doody R, Pavlik V, Massman P, et al. Changing patient characteristics and survival experience in an Alzheimer’s center patient cohort. Dementia Geriatr Cognitive Disord. 2005;20:198–208.

    Article  CAS  Google Scholar 

  38. Davis LL, Weaver M, Habermann B. Differential attrition in a caregiver skill training trial. Res Nurs Health. 2006;29:498–506.

    Article  Google Scholar 

  39. Blanton S, Morris DM, Prettyman MG et al. Lessons learned in participant recruitment and retention: the EXCITE trial. Phys Ther. 2006;86(11):1520–1533.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. University of Arkansas for Medical Sciences, Little Rock, AR, USA

    Jai Shankar K. B. Yadlapalli BPharm, MS

  2. School of Health Sciences, Eastern Michigan University, Marshall Building, Ypsilanti, MI, 48197, USA

    Irwin G. Martin PhD

Authors
  1. Jai Shankar K. B. Yadlapalli BPharm, MS
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Irwin G. Martin PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Irwin G. Martin PhD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Yadlapalli, J.S.K.B., Martin, I.G. Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation. Ther Innov Regul Sci 46, 313–319 (2012). https://doi.org/10.1177/0092861512440850

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/0092861512440850

Keywords

Search

Navigation