Abstract
Background: Equitable representation in clinical trials (CTs) is essential for the validity, generalizability, and ethical integrity of medical research. However, participation from low- and middle-income countries (LMICs) remains disproportionately low, particularly in the Middle East and North Africa (MENA) region. Iraq, despite a substantial disease burden, has minimal participation in global clinical research, and patient-level determinants of CT engagement remain largely unexplored. Understanding patient perceptions in these settings is essential to enhance recruitment in CTs.
Purpose: To assess awareness, willingness, motivators, and concerns regarding CT participation among Iraqi patients, and to identify demographic and perceptual factors associated with willingness to participate.
Methods: A multi-center, cross-sectional study was conducted using a validated 16-item interviewer-administered survey among patients attending five major teaching hospitals in Baghdad, Iraq, between October 2023 and February 2024. The survey assessed demographic characteristics, awareness of CTs, prior participation, perceived motivators and barriers, and willingness to participate under different trial scenarios (invasive, non-invasive, digital, and drug safety contexts). If a respondent reported lack of knowledge of the term ‘clinical trial,’ the investigator explained the meaning in simple Arabic to enable the respondent to participate. Descriptive statistics, univariate and multivariate analyses were performed to examine associations between participant characteristics and willingness to participate.
Results: A total of 631 patients (mean age 41.7 ± 16.2 years; 60.1% women) with generally low educational attainment (30.1% primary education; 14.4% no formal education) participated. Awareness of CTs was extremely limited, as 90.6% of participants had never heard of CTs and only 1.1% reported prior participation. More than half (51.3%) expressed concerns regarding participation, with safety being the predominant concern (85.9%), followed by family obligations that could limit trial adherence (55.8%), and fears of being experimented upon. Despite these concerns, altruistic motivations were prominent, with advancing medical science (86.4%) and helping other patients (85.4%) cited most frequently. If invited to participate in a CT, 40.1% of respondents indicated willingness, whereas 51.3% would decline and 8.6% were uncertain. Willingness varied substantially by trial characteristics: only 28.8% were willing to participate in trials involving invasive procedures, compared with the 61.2% who would participate in non-invasive studies, including educational interventions, telemedicine, or digital applications. Perceived drug safety was a key determinant, with willingness increasing to 70.8% when investigational drugs had confirmed safety, but declining sharply when safety was uncertain, with 85.9% declining willingness. Overall, educational level, prior awareness of CTs, and safety-related concerns were strongly associated with willingness to participate. In multivariable analysis, higher education (college/postgraduate) was independently associated with greater willingness to participate (OR 2.06, 95% CI 1.15–3.68), whereas having concerns about CTs was associated with reduced willingness (OR 0.42, 95% CI 0.27–0.66).
Conclusions: Iraqi patients demonstrate profound gaps in awareness of CTs and substantial safety-related concerns, yet exhibit strong altruistic motivations and openness to non-invasive and digital research models. These findings underscore the need for culturally tailored public education, transparent communication regarding trial safety, and innovative trial designs to enhance participation. Addressing these barriers is critical to improve equitable representation of LMIC populations in general and of the MENA region in particular in global clinical research, and to strengthen the external validity of CT evidence.