Keruakous Amany R, Day Silas, Garcia-Ramiu Kenny, Yarbrough Melissa, Asch Adam S
Hematology and Medical Oncology, Augusta University Medical College of Georgia, Augusta, USA.
Hematology and Medical Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, USA.
Cureus. 2021 Aug 15;13(8):e17202. doi: 10.7759/cureus.17202. eCollection 2021 Aug.
Background Clinical trials are key elements of the processes that account for many of the recent advances in cancer care. Unfortunately, they are becoming more challenging to conduct. Furthermore, a large number of clinical trials in oncology close early due to poor accrual. To identify opportunities for continued improvement in clinical trial enrollment, we sought to identify the obstacles encountered by our clinical trial research staff in these activities. Methods This is a prospective qualitative study, using Grounded Theory Methodology that was concluded at Stephenson Cancer Center (SCC). SCC has been the lead accruer to National Cancer Institute-Lead Academic Participating Sites (NCI-LAPS) trials over the past three years, and in addition, fields investigator-initiated and industry-sponsored trials. We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection, and compliance for interventional clinical trials. We then performed a follow-up meeting with our research coordinators to clarify responses. The study objectives were to highlight common barriers to recruiting adult cancer patients, encountered by research coordinators from all disease sites and to propose effective solutions to identified barriers. Results We are reporting our results of investigating barriers to clinical trials enrollment from a new perspective. The most commonly reported obstacles for clinical trials enrollment from our research staff's perspective were categorized into five themes: clinical trials protocol, communication barriers and cultural beliefs, financial barriers, patients' comorbidities and performance status, and physicians' commitment. Conclusions Although assessing barriers encountered by clinical research staff is an infrequently used metric for improving clinical trial enrollment, it provides an important perspective in the field. Implementing interventions to improve clinical trial feasibility and accrual is critical to improving cancer care.
背景 临床试验是癌症治疗近期诸多进展过程中的关键要素。不幸的是，开展临床试验正变得更具挑战性。此外，大量肿瘤学临床试验因入组不佳而提前结束。为确定在临床试验入组方面持续改进的机会，我们试图找出我们的临床试验研究人员在这些活动中遇到的障碍。方法 这是一项前瞻性定性研究，采用扎根理论方法，在斯蒂芬森癌症中心（SCC）完成。在过去三年里，SCC一直是国立癌症研究所牵头学术参与站点（NCI - LAPS）试验的主要入组机构，此外，还开展研究者发起的试验和行业赞助的试验。我们对参与干预性临床试验招募、筛查、知情同意、数据收集和合规工作的所有研究护士和疾病部位协调员等研究人员进行了调查。然后，我们与研究协调员进行了一次后续会议以澄清答复。研究目标是突出所有疾病部位的研究协调员在招募成年癌症患者时遇到的常见障碍，并针对已识别的障碍提出有效的解决方案。结果 我们正从一个新视角报告我们对临床试验入组障碍的调查结果。从我们研究人员的角度来看，临床试验入组最常报告的障碍可分为五个主题：临床试验方案、沟通障碍和文化信仰、经济障碍、患者的合并症和体能状态，以及医生的参与度。结论 尽管评估临床研究人员遇到的障碍是用于改善临床试验入组的一种较少使用的指标，但它为该领域提供了一个重要视角。实施干预措施以提高临床试验的可行性和入组率对于改善癌症治疗至关重要。
