Challenges and strategies for recruitment and retention of participants in clinical trials in Ethiopia: a qualitative study
No Thumbnail Available
Date
2020-11
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Abeba University
Abstract
Introduction: Clinical trial is an extensive and demanding process, which takes approximately
10 to 15 years. Clinical trials require the active engagement of human subjects. Recruitment and
retention of participants are two major challenges in conducting clinical trials. Poor recruitment
and retention of participants in clinical trials can lead to major delays in the development of new
products and interventions. This can also cause significant problems in the study validity as they
could reduce the statistical power resulting in poor generalizability of the study.
Objective: This study is aimed to identify potential challenges and strategies for enhancing
recruitment and retention of participants in clinical trials in Ethiopia.
Method: A qualitative methodology with a phenomenological approach employed. Semistructured
interviews were conducted face to face and through telephone. Interviewees were
purposively selected from five candidate study sites which are Armauer Hansen Research Institute,
Zewditu Memorial Hospital, University of Gondar, Jimma University, and Addis Ababa
University. These sites were chosen primarily because most clinical trials conducted in and
potential clinical investigator candidates were employed and affiliated there. Investigators, clinical
coordinators, physicians, nurses, and participants involved in clinical trials were the study
respondents. The sample size was determined using the criterion of informational redundancy. Of
22 potential respondents approached, 19 consented to the interview. An open-ended topic guide
was developed to facilitate in-depth interviews with respondents with sufficient freedom to
describe their experiences and perspectives that they deemed relevant to the research questions.
Interviews were audio-recorded with consent. Transcriptions were entered into Open Code and
coded. Data were analyzed using thematic analysis.
Result: Nine of the respondents (47.4%) were females. Respondents were involved as principal
investigators (n=5), trial coordinators (n=7), nurses (n=2), physicians (n=2) and trial participants
(n=3). Thematic analysis resulted in a generation of 3 main themes and 10 sub-themes. Clinical
trial team factors (communication and system-related), participants’ factors (communication and
interest related), and study factors (complexity of the study and cost-related) were listed as
challenges for recruitment and retention of trial participants. Additionally, four subthemes are
mentioned under the three themes as a strategy for recruitment and retention of trial participants,
such as promoting clinical trials, improving communication skills, refining the clinical trial setting system, and having a good estimation of cost. Potential challenges and strategies for recruitment
and retention of participants in clinical trials were identified under each sub-themes. Poor
communication skills, mistreating participants, and lack of knowledge about existing trials are
considered to be clinical trial team factors. Also, misconceptions about the trial, low-level
education, lack of social support, and participants’ moves around were revealed to be an important
challenge among trial participants’ factors. Also study factors such as long questionnaires and
assessment, stringent eligibility criteria, frequent appointment, and extra, and inconvenient
procedures. However, a wide range of strategies was identified such as increasing awareness,
choosing an appropriate trial site, provisions of training, reimbursement and compassionate
respectful care, and establishing an efficient tracking system may be the most important
interventions to improve recruitment and retention of trial participants.
Conclusions: Poor knowledge about research, and complexity of trials were the greatest
challenges for low recruitment and retention. Interventions to improve knowledge and provisions
of training to the clinical trial team and having compassionate respectful care, providing
compensation, increasing awareness in the community are important strategies to consider when
designing and planning recruitment and retention plan.
Description
Keywords
Challenges, Strategies, Recruitment, Retention, Clinical trial participants, Qualitative and Ethiopia