Jackson Memorial Hospital, Miami, Florida, USA.
New York State Psychiatric Institute, New York, USA.
Int J Neuropsychopharmacol. 2022 Nov 17;25(11):924-932. doi: 10.1093/ijnp/pyac058.
With numerous potentially novel targets and pharmacodynamic biomarkers for schizophrenia entering late-stage testing, the next decade will bring an urgent need for well-conducted clinical trials. A critically important step for the successful execution of clinical research trials is timely and appropriate recruitment of participants. Patients with schizophrenia can be especially challenging to recruit because of the disability inherent in psychotic spectrum disorders. Research on how best to recruit for clinical trials is understudied. Clearly defining a model for recruitment procedures would be valuable for researchers and, by extension, the patient populations that may benefit from the insight gained by future clinical research.
This article aims to offer suggestions for recruitment based on years of experience at the Columbia Schizophrenia Research Clinic (CSRC), a hub for clinical trials focusing on the etiology and treatment of various psychotic disorders.
The present report provides practical, step-by-step recommendations for implementing the highly effective CSRC recruitment model, including the benefits of 2 recruitment initiatives that were instituted in 2018: hiring a dedicated recruiter and targeted chart reviews at affiliated clinics. Other topics discussed include our umbrella protocol and database, advertising, and tips for collaborating with external sites.
Despite ongoing complications from coronavirus disease 2019, these strategies have been successful, increasing the rate of both consents and study enrollments by approximately 40% and enabling the CSRC to conduct multiple studies simultaneously.
随着大量针对精神分裂症的潜在新型靶点和药效学生物标志物进入后期测试阶段，未来十年将迫切需要进行精心设计的临床试验。对于成功执行临床研究试验来说，一个至关重要的步骤是及时、适当地招募参与者。由于精神分裂症患者存在精神障碍，因此招募他们极具挑战性。对于如何最好地招募他们参加临床试验的研究还不够深入。明确一个招募程序模型对于研究人员来说将是非常有价值的，并且可以将从未来临床研究中获得的洞察力扩展到可能受益的患者群体。
本文旨在根据哥伦比亚精神分裂症研究诊所（CSRC）多年的经验，为招募提供建议，该诊所是专注于各种精神障碍病因和治疗的临床试验中心。
本报告提供了实施高效 CSRC 招募模型的实用、逐步的建议，包括 2018 年实施的 2 项招募计划的好处：聘请专门的招募人员和在附属诊所进行有针对性的图表审查。其他讨论的主题包括我们的总协议和数据库、广告以及与外部网站合作的技巧。
尽管持续受到 2019 冠状病毒病的影响，但这些策略取得了成功，使同意率和研究入组率提高了约 40%，使 CSRC 能够同时进行多项研究。
