Gharaibeh Lobna, Sartawi Hanan, Alzoubi Karem, Juma Tareq, Ayyad Diana, Sartawi Samah
School of Pharmacy, University of Jordan, Amman, 11942, Jordan.
Pharmacy Department, Al-Basheer Government Hospital, Amman, 11151, Jordan.
Int J Clin Pharm. 2020 Feb;42(1):201-208. doi: 10.1007/s11096-019-00959-4. Epub 2020 Feb 14.
Background The number of global clinical trials is increasing. Recruitment rate in clinical trials is a challenging task that affects sample size, power of the study, and adequate representation of the targeted population. An understanding of the worries and reasons why patients may refrain from participation in trials may lead to improved enrollment rates. Objectives To assess the rate of patients who are willing to participate in clinical trials, and aspects that might have an impact on the patients' willingness to participate. Setting Government tertiary hospital in Jordan. Methods This is a cross-sectional study. Patients were interviewed by pharmacists in different clinics in a tertiary hospital and information was collected using a data collection sheet. Main outcome measure Factors that might predict the inclination of a patient to participate in clinical trials, and the rate of willingness to participation in randomized controlled trials in cancer patients compared to non-cancer patients. Results A total of 1193 participants were enrolled in the study, one hundred and thirty-five participants (11.3%) had cancer and 80% of the participants had at least one chronic medical condition. Majority of patients (n = 882, 73.9%) believed that trials were safe and 1106 (92.7%) patients thought they were important. Age, education level, income, having cancer or any chronic medical condition, and degree of control of chronic diseases were statistically significant predictors of the willingness of patients to participate in trials. Patients with cancer had a higher rate of acceptance to participation in randomized controlled trials compared to non-cancer patients, 80.0% versus 62.4%, p value < 0.001. Conclusion In general, almost two-thirds of patients were willing to participate in clinical trials, with a higher rate in cancer patients. Factors such as education level, income, and extent of control of medical conditions that might refrain patients from enrollment in trials will lower recruitment rate and must be addressed and taken into consideration before launching clinical trials.
背景 全球临床试验的数量在不断增加。临床试验中的招募率是一项具有挑战性的任务,它会影响样本量、研究效能以及目标人群的充分代表性。了解患者不愿参与试验的担忧和原因可能会提高入组率。
目的 评估愿意参与临床试验的患者比例,以及可能影响患者参与意愿的因素。
地点 约旦的政府三级医院。
方法 这是一项横断面研究。药剂师在三级医院的不同诊所对患者进行访谈,并使用数据收集表收集信息。
主要观察指标 可能预测患者参与临床试验倾向的因素,以及与非癌症患者相比,癌症患者参与随机对照试验的意愿率。
结果 共有1193名参与者纳入研究,135名参与者(11.3%)患有癌症,80%的参与者至少有一种慢性疾病。大多数患者(n = 882,73.9%)认为试验是安全的,1106名(92.7%)患者认为试验很重要。年龄、教育水平、收入、患有癌症或任何慢性疾病以及慢性病的控制程度是患者参与试验意愿的统计学显著预测因素。与非癌症患者相比,癌症患者参与随机对照试验的接受率更高,分别为80.0%和62.4%,p值<0.001。
结论 总体而言,近三分之二的患者愿意参与临床试验,癌症患者的比例更高。教育水平、收入以及可能使患者不愿入组试验的医疗状况控制程度等因素会降低招募率,在开展临床试验之前必须加以解决和考虑。