Departments of Psychiatry and Anesthesiology, Washington University School of Medicine, St Louis, MO, USA.
Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Neuropsychopharmacology. 2024 Jan;49(1):205-214. doi: 10.1038/s41386-023-01664-7. Epub 2023 Aug 7.
Mental health treatment advances - including neuropsychiatric medications and devices, psychotherapies, and cognitive treatments - lag behind other fields of clinical medicine such as cardiovascular care. One reason for this gap is the traditional techniques used in mental health clinical trials, which slow the pace of progress, produce inequities in care, and undermine precision medicine goals. Newer techniques and methodologies, which we term digital and precision trials, offer solutions. These techniques consist of (1) decentralized (i.e., fully-remote) trials which improve the speed and quality of clinical trials and increase equity of access to research, (2) precision measurement which improves success rate and is essential for precision medicine, and (3) digital interventions, which offer increased reach of, and equity of access to, evidence-based treatments. These techniques and their rationales are described in detail, along with challenges and solutions for their utilization. We conclude with a vignette of a depression clinical trial using these techniques.
精神健康治疗的进步——包括神经精神药物和设备、心理疗法和认知治疗——落后于心血管护理等其他临床医学领域。造成这种差距的一个原因是精神健康临床试验中使用的传统技术，这些技术减缓了进展速度，导致护理的不平等，并破坏了精准医学的目标。我们称之为数字和精准试验的新技术和方法提供了一些解决方案。这些技术包括：（1）去中心化（即完全远程）试验，可提高临床试验的速度和质量，并增加获得研究的公平性；（2）精准测量，可提高成功率，对精准医学至关重要；（3）数字干预，可增加基于证据的治疗方法的普及性和公平性。详细描述了这些技术及其基本原理，以及它们的应用所面临的挑战和解决方案。最后，我们通过一个使用这些技术的抑郁症临床试验案例进行了说明。
