Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Trials. 2023 Apr 10;24(1):263. doi: 10.1186/s13063-023-07276-2.
There are many reasons why the majority of clinical trials fail or have limited applicability to patient care. These include restrictive entry criteria, short duration studies, unrecognized adverse drug effects, and reporting of therapy assignment preferential to actual use. Frequently, experimental animal models are used sparingly and do not accurately simulate human disease. We suggest two approaches to improve the conduct, increase the success, and applicability of clinical trials. Studies can apply dosing of the investigational therapeutics and outcomes, determined from animal models that more closely simulate human disease. More extensive identification of known and potential risk factors and confounding issues, gleaned from recently organized "big data," should be utilized to create models for trials. The risk factors in each model are then accounted for and managed during each study.
大多数临床试验失败或对患者护理的应用有限，原因有很多。这些原因包括限制准入标准、研究持续时间短、未识别的药物不良反应以及偏向实际使用的治疗分配报告。通常，实验动物模型使用不足，并且不能准确模拟人类疾病。我们建议采用两种方法来提高临床试验的进行、成功率和适用性。研究可以应用从更接近模拟人类疾病的动物模型中确定的研究治疗药物的剂量和结果。从最近组织的“大数据”中获取的已知和潜在风险因素以及混杂问题的更广泛识别，应该用于创建试验模型。然后，在每个模型中考虑并管理每个研究中的风险因素。
