Department of Biomedical Informatics, Columbia University, New York, New York, USA.
Observational Health Data Sciences and Informatics, New York, New York, USA.
J Am Med Inform Assoc. 2021 Oct 12;28(11):2456-2460. doi: 10.1093/jamia/ocab164.
Evidence is scarce regarding the safety of long-term drug use, especially for drugs treating chronic diseases. To bridge this knowledge gap, this research investigated the differences in drug exposure between clinical trials and clinical practice.
We extracted drug follow-up times from clinical trials in ClinicalTrials.gov and compared the difference between clinical trials and real-world usage data for 914 drugs taken by 96 645 927 patients.
A total of 17.5% of drugs had longer median exposure in practice than in trials, 6% of patients had extended exposure to at least 1 drug, and drugs treating nervous system disorders and cardiovascular diseases were the most common among drugs with high rates of extended exposure.
For most of patients, the drug use length is shorter than the tested length in clinical trials. Still, a remarkable number of patients experienced extended drug exposure, particularly for drugs treating nervous system disorders or cardiovascular disorders.
长期用药的安全性证据稀缺，尤其是治疗慢性病的药物。为弥补这一知识空白，本研究调查了临床试验和临床实践中药物暴露的差异。
我们从 ClinicalTrials.gov 中提取了临床试验中的药物随访时间，并比较了 9645927 名患者使用的 914 种药物在临床试验和真实世界使用数据中的差异。
共有 17.5%的药物在实际应用中的中位暴露时间长于临床试验，6%的患者至少有 1 种药物的暴露时间延长，治疗神经系统疾病和心血管疾病的药物在延长暴露药物中最为常见。
对于大多数患者来说，药物使用时间短于临床试验中的测试时间。尽管如此，仍有相当数量的患者经历了延长的药物暴露，特别是治疗神经系统疾病或心血管疾病的药物。
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