Park Eliza M, Raddin Ryan S, Nelson Kelly M, Hamer Robert M, Mayer Deborah K, Bernard Stephen A, Rosenstein Donald L
Department of Psychiatry, University of North Carolina, Chapel Hill, NC.
Bon Secours Cancer Institute, Richmond, VA.
Gen Hosp Psychiatry. 2014 Sep-Oct;36(5):474-6. doi: 10.1016/j.genhosppsych.2014.05.007. Epub 2014 May 17.
The aim of this report is to discuss the design of an antidepressant clinical trial and discuss the challenges and potential solutions to these challenges to successful recruitment of oncology patients for psychopharmacology trials.
We utilize meeting minutes and investigator discussions to identify the modifiable and nonmodifiable variables that affected successful subject recruitment for this study.
No subjects were enrolled in our placebo-controlled antidepressant trial. After study modification to remove the placebo arm, we enrolled 21 subjects with depression and cancer. We identified the following recruitment difficulties during the study: diagnostic ambiguity in patients with depression and cancer, lowered subject retention in a medically ill population, patient reluctance to enroll in placebo-controlled studies and lack of a standardized referral processes for antidepressant studies in oncology at our institution.
Our experience provides guidance on specific factors that future clinicians and researchers can consider when implementing psychopharmacologic trials in the medically ill.
本报告旨在探讨一项抗抑郁药物临床试验的设计，并讨论在精神药理学试验中成功招募肿瘤患者所面临的挑战以及应对这些挑战的潜在解决方案。
我们利用会议记录和研究者讨论来确定影响本研究成功招募受试者的可改变和不可改变变量。
我们的安慰剂对照抗抑郁试验未招募到任何受试者。在研究修改以去除安慰剂组后，我们招募了21名患有抑郁症和癌症的受试者。我们在研究过程中确定了以下招募困难：抑郁症和癌症患者的诊断不明确、患有内科疾病人群中受试者保留率降低、患者不愿参加安慰剂对照研究以及我们机构缺乏针对肿瘤学抗抑郁研究的标准化转诊流程。
我们的经验为未来临床医生和研究人员在患有内科疾病的患者中开展精神药理学试验时可考虑的具体因素提供了指导。
