Literature DB >> 29920291

Community-based recruitment for clinical trials poses the need for social and ethical considerations.

Mary Ann J Ladia1, Olivia T Sison2, Cora A Añonuevo3, Marissa M Alejandria2.   

Abstract

OBJECTIVE: This article's objective was to describe the processes, strategies, and challenges of community-based recruitment to complement hospital-based recruitment for a global clinical outcomes trial on chronic obstructive pulmonary disease (COPD). STUDY DESIGN AND
SETTING: To increase the subject recruitment for the clinical research, field staff were trained on community-based recruitment strategies and activities. Courtesy calls and coordination with community organizations were done before recruitment activities. House-to-house interviews using patient referral checklist, lay fora on COPD, and spirometry camps identified eligible participants in five sites in the Philippines.
RESULTS: Of 3,202 individuals interviewed, 27% potentially eligible were referred to hospital sites. Of 55% who were successfully screened, 9% were randomized. Courtesy calls and endorsements identified potential recruits. Issues related to communication, work, health condition, and family members' encouragement affected participation. Complexity of the eligibility criteria contributed to the high screen failure rates. Enabling full subject protection entitlements before informed consent taking was one of the ethical issues identified.
CONCLUSIONS: Community-based recruitment may increase the number of subjects for clinical trials depending on the complexity of the requirements. Adopting a community-based recruitment strategy must be decided at the planning stage for efficient coordination of activities. Social preparation should consider socioeconomic and cultural factors. Current ethical guidelines and regulations indirectly address issues on community-based recruitment.
Copyright © 2018 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  COPD; Clinical trial; Community-based recruitment; Ethical guidelines; Low- and middle-income country; Philippines

Mesh:

Year:  2018        PMID: 29920291     DOI: 10.1016/j.jclinepi.2018.06.002

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  2 in total

1.  African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial.

Authors:  Macy L Stockdill; J Nicholas Dionne-Odom; Rachel Wells; Deborah Ejem; Andres Azuero; Konda Keebler; Elizabeth Sockwell; Sheri Tims; Kathryn L Burgio; Sally Engler; Raegan Durant; Salpy V Pamboukian; Jose Tallaj; Keith M Swetz; Elizabeth Kvale; Rodney Tucker; Marie Bakitas
Journal:  J Palliat Care       Date:  2020-12-01       Impact factor: 1.980

2.  Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process.

Authors:  Bin Li; Qian Zhang; Yuanyuan Liu; Xiaolei Zhang; Dongmei Cheng; Aolin Li; Yubing Chen; Xingyu Zhu; Yue Su; Huan Zhou
Journal:  Ann Transl Med       Date:  2021-10
  2 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.