Hass Adam, Guzman Jonathan C A, Feuerstein Michael A
Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States.
Department of Urology, Lenox Hill Hospital, New York, NY, United States.
Can Urol Assoc J. 2023 Mar;17(3):E67-E74. doi: 10.5489/cuaj.8011.
Most cancer patients are never enrolled in clinical trials, resulting in missed potential therapeutic benefits to patients and barriers to drug development and approval. With a focus on urologic oncology clinical trials, we reviewed the current literature on barriers to accrual and present effective interventions to overcome these barriers.
PubMed was searched for articles regarding physician referral and patient accrual to clinical trials in urologic oncology from January 2000 through June 2021. Studies were included if they were in English, related to clinical trial utilization or patient accrual in urologic oncology, peer-reviewed, primary research, survey, or systematic review, and pertained to clinical trials in the U.S. Major overlapping themes related to barriers to accrual and effective interventions were identified.
Thirty-six studies met our inclusion criteria. Barriers fall into three categories: 1) provider; 2) patient; or 3) structural. Provider barriers include issues such as poor funding, logistical challenges, and time constraints. Patient barriers include cost, distrust of medical institutions, and lack of knowledge regarding ongoing studies. Structural barriers include lack of time and resources in community settings and difficulty with physician referrals. Effective strategies identified include increasing provider referrals through continuing education and referral pathways, increasing patient education through patient-centered marketing material, and decreasing structural barriers through patient navigation programs and community partnerships.
We identified barriers and potential multipronged strategies targeted at patients, providers, and practices to increase clinical trial enrollment. We hope these strategies will benefit patients and providers and facilitate research development.
大多数癌症患者从未参与过临床试验,这导致患者错失了潜在的治疗益处,也给药物研发和审批带来了障碍。我们聚焦于泌尿肿瘤学临床试验,回顾了当前关于入组障碍的文献,并介绍了克服这些障碍的有效干预措施。
在PubMed数据库中检索2000年1月至2021年6月期间有关泌尿肿瘤学临床试验中医生转诊和患者入组的文章。纳入标准为英文撰写、与泌尿肿瘤学临床试验利用或患者入组相关、经过同行评审、为原发性研究、调查或系统评价且涉及美国的临床试验。确定了与入组障碍和有效干预措施相关的主要重叠主题。
36项研究符合我们的纳入标准。障碍分为三类:1)提供者;2)患者;或3)结构方面。提供者障碍包括资金不足、后勤挑战和时间限制等问题。患者障碍包括费用、对医疗机构的不信任以及对正在进行的研究缺乏了解。结构障碍包括社区环境中时间和资源不足以及医生转诊困难。确定的有效策略包括通过继续教育和转诊途径增加提供者转诊,通过以患者为中心的营销材料增加患者教育,以及通过患者导航计划和社区伙伴关系减少结构障碍。
我们确定了针对患者、提供者和医疗机构的障碍及潜在的多管齐下策略,以增加临床试验入组。我们希望这些策略将使患者和提供者受益,并促进研究发展。