Exploring Factors Affecting Participation in Oncology Clinical Trials in Saudi Arabia: Insights Into Willingness and...

To assess willingness of patients with cancer to participate in observational studies (OBS) and clinical trials (CT) and to examine the factors influencing their decision to join CT.

A cross-sectional study using a systematic sampling strategy was conducted from December 2023 to June 2024. Data were collected directly from patients and their medical charts. Logistic regression was performed to identify significant predictors of patients' willingness to participate in CT.

A total of 367 patients participated, 58.9% were females, and 59.8% had stage IV disease. Most participants (81%) had a performance status (PS) of 0-1, with only 1.9% having prior experience with a CT and 9% with OBS. Willingness to join OBS was higher than willingness to join CT (64% v 31.6%, P < .001). Key barriers included fear of side effects (61.6%), lack of information (46.3%), and concerns about the investigational product (41.6%). Motivators were having their treating physician as the principal investigator (42.5%) and prior human testing of the product (40.6%). Patients who underwent surgery or believed that their physical or psychological condition is unsuitable for trials were less likely to participate (P < .05, odds ratio [OR], 0.30, 0.38, 0.37, respectively). Patients with a friend or relative who had joined a trial were more willing to participate (P < .05, OR, 3.48).

The results highlight a low level of willingness to participate in CT. Some barriers could be avoided during the study design phase. Discrepancies between patients' self-assessed PS and physicians' evaluations may lower the enrollment rates. Encouraging patients who have participated in CTs to share their experiences with the family and friends could significantly improve the community's willingness to join CT.