Recruitment and retention of pregnant women into clinical research trials: An overview of challenges, facilitators, and best practices

Paula M. Frew, Diane S. Saint-Victor, Margaret Brewinski Isaacs, Sonnie Kim, Geeta K. Swamy, Jeanne S. Sheffield, Kathryn M. Edwards, Tonya Villafana, Ouda Kamagate, Kevin Ault

Research output: Contribution to journalReview article

44 Citations (Scopus)

Abstract

Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.

Original languageEnglish (US)
Pages (from-to)S400-S407
JournalClinical Infectious Diseases
Volume59
DOIs
StatePublished - 2014

Fingerprint

Practice Guidelines
Pregnant Women
Clinical Trials
Research
Population
Lenses
Longitudinal Studies
Cohort Studies
Organizations
Clinical Studies
Therapeutics

Keywords

  • Clinical research trials
  • Pregnant women
  • Recruitment
  • Retention
  • Vulnerable populations

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Recruitment and retention of pregnant women into clinical research trials : An overview of challenges, facilitators, and best practices. / Frew, Paula M.; Saint-Victor, Diane S.; Isaacs, Margaret Brewinski; Kim, Sonnie; Swamy, Geeta K.; Sheffield, Jeanne S.; Edwards, Kathryn M.; Villafana, Tonya; Kamagate, Ouda; Ault, Kevin.

In: Clinical Infectious Diseases, Vol. 59, 2014, p. S400-S407.

Research output: Contribution to journalReview article

Frew, PM, Saint-Victor, DS, Isaacs, MB, Kim, S, Swamy, GK, Sheffield, JS, Edwards, KM, Villafana, T, Kamagate, O & Ault, K 2014, 'Recruitment and retention of pregnant women into clinical research trials: An overview of challenges, facilitators, and best practices', Clinical Infectious Diseases, vol. 59, pp. S400-S407. https://doi.org/10.1093/cid/ciu726
Frew, Paula M. ; Saint-Victor, Diane S. ; Isaacs, Margaret Brewinski ; Kim, Sonnie ; Swamy, Geeta K. ; Sheffield, Jeanne S. ; Edwards, Kathryn M. ; Villafana, Tonya ; Kamagate, Ouda ; Ault, Kevin. / Recruitment and retention of pregnant women into clinical research trials : An overview of challenges, facilitators, and best practices. In: Clinical Infectious Diseases. 2014 ; Vol. 59. pp. S400-S407.
@article{4812ad9c54234b76b5dc6be0b781843b,
title = "Recruitment and retention of pregnant women into clinical research trials: An overview of challenges, facilitators, and best practices",
abstract = "Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.",
keywords = "Clinical research trials, Pregnant women, Recruitment, Retention, Vulnerable populations",
author = "Frew, {Paula M.} and Saint-Victor, {Diane S.} and Isaacs, {Margaret Brewinski} and Sonnie Kim and Swamy, {Geeta K.} and Sheffield, {Jeanne S.} and Edwards, {Kathryn M.} and Tonya Villafana and Ouda Kamagate and Kevin Ault",
year = "2014",
doi = "10.1093/cid/ciu726",
language = "English (US)",
volume = "59",
pages = "S400--S407",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",

}

TY - JOUR

T1 - Recruitment and retention of pregnant women into clinical research trials

T2 - An overview of challenges, facilitators, and best practices

AU - Frew, Paula M.

AU - Saint-Victor, Diane S.

AU - Isaacs, Margaret Brewinski

AU - Kim, Sonnie

AU - Swamy, Geeta K.

AU - Sheffield, Jeanne S.

AU - Edwards, Kathryn M.

AU - Villafana, Tonya

AU - Kamagate, Ouda

AU - Ault, Kevin

PY - 2014

Y1 - 2014

N2 - Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.

AB - Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.

KW - Clinical research trials

KW - Pregnant women

KW - Recruitment

KW - Retention

KW - Vulnerable populations

UR - http://www.scopus.com/inward/record.url?scp=84979862380&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84979862380&partnerID=8YFLogxK

U2 - 10.1093/cid/ciu726

DO - 10.1093/cid/ciu726

M3 - Review article

C2 - 25425718

AN - SCOPUS:84979862380

VL - 59

SP - S400-S407

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

ER -