Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal

Abstract

Due to the inherent complex nature of clinical trials, individual’s willingness to participate and hence, enrollment in a clinical trial maybe challenging. When it comes to vaccine clinical trial in children, informed consent needs to be secured from the parents or legally acceptable representatives (LARs). Some of the factors which contribute to hesitancy in taking part in clinical trials are based on the level of education, living standards, part of the world they live, associated burden of disease, fear of different procedures in clinical trial, side effects, limited understanding, limited time, and mistrust with Investigational product. This study included 201 parents/LARs, who approached Kanti Children Hospital site in Kathmandu with the interest to get their children enrolled in a vaccine clinical trial with objectives of describing the reasons for agreeing or disagreeing to participate in the vaccine clinical trial, factors affecting decision making, and finding the major concerns of parents/LARs. The acceptance for the study vaccine was 136 (67.7%) whereas denial was 65 (32.3%). This study showed that age, education level, family structure, advice from family and friends, and medical guidance play important roles in willingness of parents to get their child enrolled in the trial. If a proper counseling is done, fear of blood sampling is not a big factor which is contrary to the belief among clinical researchers. Safety of vaccine, frequency of injections, and cost of vaccine were the main concerns of the parents, which need to be addressed extensively while planning for any clinical trial in children.

Impact of caregivers' psychological and caregiving status on recruitment, conversion, and retention in stem cell therapy trials for cerebral palsy: A prospective survey analysis

“…Additionally, a recent study showed that patients with better psychological status for anaesthesia and surgery were more willing to take part in relevant clinical trials (Noirmain et al, 2020). These results have been confirmed in parents' inclusion of their children in vaccination clinical trials (Chapagain et al, 2022). Care burden are the adverse experiences or negative changes in a caregiver's physical health, financial situation, social life, and other factors when carrying out care work.…”

“…This suggests that strengthening care ability can help conduct clinical trials (Duncan et al, 2018 ). Additionally, a recent study on childhood vaccination clinical trials suggested that accessing social and medical resources, that is, enabling care ability, could increase parents' willingness to enrol their children in trials (Chapagain et al, 2022 ). Although the impact of psychological factors, such as care ability and burden on the willingness and retention to participate in clinical trials has received considerable attention, the number of reports is limited.…”