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Research, Methods, Statistics

Practical Guide to Recruitment of Participants for Surgical Clinical Trials

To identify the key insights or developments described in this article
1 Credit CME
JAMA Surgery
Published Online: October 26, 2022
Guide to Statistics and Methods
Lisa A. Newman, MD, MPH1;
Todd A. Schwartz, DrPH, MS2,3;
Marja Boermeester, MD, PhD4
Author Affiliations
  • 1Department of Surgery, Weill Cornell Medicine, New York, New York
  • 2Department of Biostatistics, University of North Carolina at Chapel Hill
  • 3Statistical Editor, JAMA Surgery
  • 4Department of Surgery, Amsterdam University Medical Center, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
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Prospective randomized clinical trials are considered to produce the highest-level evidence regarding intervention benefits for the health and well-being of the study population. Patient participation requires confidence and trust.

We live in a diverse society, characterized by a spectrum of genetic, lifestyle, and socioeconomic features that can influence efficacy of a drug or intervention. Research results cannot be generalized unless trial participants reflect the diversity of the large-scale community. An important first step in ensuring such representation involves having a clinical trial research team that is diverse and cognizant of overall population heterogeneity. Relevant research questions must be aligned with appropriate statistical plans.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

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Geriatrics Research, Methods, Statistics Surgery JAMA Guide to Statistics and Methods Equity, Diversity, and Inclusion Guide to Statistics and Methods
Article Information

Corresponding Author: Lisa A. Newman, MD, MPH, Department of Surgery, Weill Cornell Medicine, 420 E 70th St, New York, NY 10021 (lan4002@med.cornell.edu).

Published Online: October 26, 2022. doi:10.1001/jamasurg.2022.4886

Conflict of Interest Disclosures: None reported.

References
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Emerson  MA , Reeder-Hayes  KE , Tipaldos  HJ ,  et al.  Integrating biology and access to care in addressing breast cancer disparities: 25 years’ research experience in the Carolina Breast Cancer Study.   Curr Breast Cancer Rep. 2020;12(3):149-160. doi:10.1007/s12609-020-00365-0PubMedGoogle ScholarCrossref
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Newman  LA , Lee  CT , Parekh  LP ,  et al; American College of Surgeons Oncology Group (ACOSOG) Special Population Committee.  Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee.   Cancer. 2006;106(1):188-195. doi:10.1002/cncr.21592PubMedGoogle ScholarCrossref
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Sineshaw  HM , Gaudet  M , Ward  EM ,  et al.  Association of race/ethnicity, socioeconomic status, and breast cancer subtypes in the National Cancer Data Base (2010-2011).   Breast Cancer Res Treat. 2014;145(3):753-763. doi:10.1007/s10549-014-2976-9PubMedGoogle ScholarCrossref
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Magnuson  A , Bruinooge  SS , Singh  H ,  et al.  Modernizing Clinical Trial Eligibility Criteria: recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group.   Clin Cancer Res. 2021;27(9):2424-2429. doi:10.1158/1078-0432.CCR-20-3868PubMedGoogle ScholarCrossref
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US Department of Health & Human Services. Additional protections for pregnant women, human fetuses and neonates involved in research. Accessed February 1, 2022. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-b/index.html
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Reaman  GH .  Pediatric cancer research from past successes through collaboration to future transdisciplinary research.   J Pediatr Oncol Nurs. 2004;21(3):123-127. doi:10.1177/1043454204264406PubMedGoogle ScholarCrossref
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Eggly  S , Barton  E , Winckles  A , Penner  LA , Albrecht  TL .  A disparity of words: racial differences in oncologist-patient communication about clinical trials.   Health Expect. 2015;18(5):1316-1326. doi:10.1111/hex.12108PubMedGoogle ScholarCrossref
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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