Skip to main content

Defining the Study Cohort: Inclusion and Exclusion Criteria

  • Chapter
  • First Online:
Clinical Trials

Abstract

A study cohort is a group of individuals with common characteristics who are initially defined, composed and then examined or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific eligibility criteria. Inclusion criteria and exclusion criteria together determine who is eligible to participate in the study. These selection or eligibility criteria are determined during the planning phase of the study, with the study goals of the clinical trial in mind. Establishing eligibility criteria primarily requires the precise definition of the primary and secondary study outcomes, which provides guidance for the sample size of the clinical trial that is required to detect a significant difference between the study intervention and control group. The eligibility criteria should be sufficiently narrow to ensure internal study validity, but sufficiently broad to allow for generalizability of the study results to the general population. In addition, eligibility criteria must be chosen carefully to allow for the feasible recruitment of study subjects into the clinical trial and must meet ethical criteria established by the National Institutes of Health (NIH).

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

Access this chapter

eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 69.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  1. ClinicalTrials.gov. Learn about clinical studies. https://clinicaltrials.gov/ct2/about-studies/learn. Accessed 25 July 2019.

  2. Underwood RT. Basic design considerations. In: Chow S-C, Liu J-P, editors. Design and analysis of clinical trials: concepts and methodologies. 3rd ed. New York: John Wiley & Sons; 2014. p. 85–115.

    Google Scholar 

  3. Kim ES, Bernstein D, Hilsenbeck SG, et al. Modernizing eligibility criteria for molecularly driven trials. J Clin Oncol. 2015;33(25):2815–20.

    Article  CAS  Google Scholar 

  4. Van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297(11):1233–40.

    Article  Google Scholar 

  5. Brody T. Inclusion/exclusion criteria, stratification, and subgroups—part I. In: Brody T, editor. Clinical trials. 2nd ed. Amsterdam: Elsevier; 2016. p. 83–113.

    Chapter  Google Scholar 

  6. Chin RY, Lee BY. Patient selection and sampling: key components of clinical trials and programs. In: Principles and practice of clinical trial medicine. Boston: Academic; 2008.

    Google Scholar 

  7. Nottage M, Siu LL. Principles of clinical trial design. J Clin Oncol. 2002;20(18 Suppl):42S–6S.

    PubMed  Google Scholar 

  8. Szklo M. Population-based cohort studies. Epidemiol Rev. 1998;20(1):81–90.

    Article  CAS  Google Scholar 

  9. Ellimoottil C, Vijan S, Flanigan RC. A primer on clinical trial design. Urol Oncol Semin Orig Investig. 2015;33(3):116–21.

    Article  Google Scholar 

  10. Stock E, Biswas K. Sample size calculation. In: Itani KMF, Reda D, editors. Clinical trials design in operative and non operative invasive procedures. New York: Springer International Publishing; 2017. p. 141–50.

    Chapter  Google Scholar 

  11. Pocock SJ, Clayton TC, Stone GW. Design of major randomized trials: part 3 of a 4-part series on statistics for clinical trials. J Am Coll Cardiol. 2015;66(24):2757–66.

    Article  Google Scholar 

  12. Browner W, Newman T, Cummings S, Hulley S. Estimating sample size and power. In: Hulley S, Cummings S, Browner W, Grady D, Hearst N, Newman T, editors. Designing clinical research: an epidemiologic approach. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2001. p. 65–84.

    Google Scholar 

  13. Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet. 2005;365(9467):1348–53.

    Article  Google Scholar 

  14. Kirby A, Gebski V, Keech AC. Determining the sample size in a clinical trial. Med J Aust. 2002;177(5):256–7.

    Article  Google Scholar 

  15. Caldwell PHY, Hamilton S, Tan A, Craig JC. Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med. 2010;7(11):e1000368.

    Article  Google Scholar 

  16. Treweek S, Pitkethly M, Cook J, et al. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;2(2):MR000013.

    Google Scholar 

  17. Itani KMF, Reda DJ. Clinical trials design in operative and nonoperative invasive procedures. Clin Trials Des Oper Non Oper Invasive Proced. 2017;112:1–495.

    Google Scholar 

  18. Beaver JA, Ison G, Pazdur R. Reevaluating eligibility criteria—balancing patient protection and participation in oncology trials. N Engl J Med. 2017;376(16):1504–5.

    Article  Google Scholar 

  19. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/#. Published 1979. Accessed 25 July 2019.

  20. U.S. Department of Health and Human Services. National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as participants in research involving human subjects. https://grants.nih.gov/policy/inclusion/women-and-minorities.htm. Accessed 25 July 2019.

  21. National Institutes of Health. Guidelines for the review of inclusion on the basis of sex/gender, race, ethnicity, and age in clinical research. https://grants.nih.gov/grants/peer/guidelines_general/Review_Human_subjects_Inclusion.pdf. Accessed 25 July 2019.

  22. U.S. Department of Health and Human Services. National Institutes of Health. NIH policy and guidelines on the inclusion of individuals across the lifespan as participants in research involving human subjects. https://grants.nih.gov/policy/inclusion/lifespan.htm. Accessed 25 July 2019.

  23. Jin S, Pazdur R, Sridhara R. Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational newdrug applications in 2015. J Clin Oncol. 2017;35(33):3745–52.

    Article  CAS  Google Scholar 

  24. Penel N, Lebellec L, Vanseymortier M. Reappraisal of eligibility criteria in cancer clinical trials. Curr Opin Oncol. 2018;30(5):352–7.

    Article  Google Scholar 

  25. Lichtman SM, Harvey RD, Damiette Smit M-A, et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-Friends of Cancer research organ dysfunction, prior or concurrent malignancy, and Comorbidities Working Group. J Clin Oncol. 2017;35(33):3753–9.

    Article  CAS  Google Scholar 

  26. Gore L, Ivy SP, Balis FM, et al. Modernizing clinical trial eligibility: recommendations of the American Society of Clinical Oncology-friends of Cancer research minimum age working group. J Clin Oncol. 2017;35(33):3781–7.

    Article  CAS  Google Scholar 

  27. Uldrick TS, Ison G, Rudek MA, et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-friends of Cancer research HIV working group. J Clin Oncol. 2017;35(33):3774–80.

    Article  CAS  Google Scholar 

  28. Lin NU, Prowell T, Tan AR, et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-friends of Cancer research brain metastases working group. J Clin Oncol. 2017;35(33):3760–73.

    Article  CAS  Google Scholar 

  29. Moher D, Schulz KF, Altman D. CONSORT group (consolidated standards of reporting trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285(15):1987–91.

    Article  CAS  Google Scholar 

  30. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276(8):637–9.

    Article  CAS  Google Scholar 

  31. The CONSORT statement. http://www.consort-statement.org/. Accessed 25 July 2019.

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Elizabeth G. Grubbs .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Keung, E.Z., McElroy, L.M., Ladner, D.P., Grubbs, E.G. (2020). Defining the Study Cohort: Inclusion and Exclusion Criteria. In: Pawlik, T., Sosa, J. (eds) Clinical Trials. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-35488-6_5

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-35488-6_5

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-35487-9

  • Online ISBN: 978-3-030-35488-6

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics