JMIR Publications

ABSTRACT

Background:

Clinical trials are a crucial element in advancing medical knowledge and developing new treatments by establishing the evidence base for safety and therapeutic efficacy. However, the success of these trials depends on various factors, including trial design, project planning, research staff training, and having an adequate sample size. It is also crucial to recruit participants efficiently and retain them throughout the trial to ensure timely completion.

Objective:

There is a rising interest in using electronic health record (EHR) –a widely adopted tool in clinical practice—for clinical trials. We conducted a scoping review to understand the use of EHR in supporting the conduct of clinical trials in low- and middle-income countries (LMICs), and to identify its strengths and limitations.

Methods:

A comprehensive search was performed from five databases: PubMed/MEDLINE, Embase, Scopus, Cochrane Library, and Cumulated Index to Nursing and Allied Health Literature. We included clinical trials that used EHR at any step, conducted narrative synthesis of included studies, and mapped the roles of EHRs into the life cycle of a clinical trial.

Results:

Thirty studies met the inclusion criteria, among which 13 were randomized controlled trials (RCTs), three were cluster-RCTs, 12 were quasi-experimental studies, and two feasibility/pilot studies. The majority of the studies addressed infectious diseases (n=15) with 80% of them about HIV/AIDS, while another twelve studies focused on non-communicable diseases. Our synthesis culminated the roles of EHRs into 7 major categories: participant identification and recruitment (n=12), baseline information collection (n=6), intervention (n=8); fidelity assessment (n=2), primary outcome assessment (n=24), non-primary outcome assessment (n=13), and extended follow-up (n=2). None of the studies used EHR for participant consent and randomization.

Conclusions:

Despite EHRs have enormous potential to increase the effectiveness and efficiency of conducting clinical trials in LMICs, challenges remain. Continued exploration of appropriate uses of EHRs by navigating its strengths and limitations to ensure fitness for use is necessary to better understand the most optimal uses of EHRs for conducting clinical trials in LMICs.