Abstract

Objective

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.

Materials and Methods

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.

Results

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.

Conclusions

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.

中文翻译：

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从临床试验到临床实践：药物经过多长时间的测试，然后被患者使用？

摘要

客观的

关于长期用药安全性的证据很少，尤其是治疗慢性病的药物。为了弥合这一知识差距，本研究调查了临床试验和临床实践之间药物暴露的差异。

材料和方法

我们从 ClinicalTrials.gov 中的临床试验中提取药物随访时间，并比较了 96 645 927 名患者服用的 914 种药物的临床试验与真实世界使用数据之间的差异。

结果

共有 17.5% 的药物在实践中的中位暴露时间比试验中长，6% 的患者至少延长了 1 种药物的暴露时间，治疗神经系统疾病和心血管疾病的药物在延长暴露率高的药物中最为常见。暴露。

结论

对于大多数患者来说，药物使用长度比临床试验中测试的长度要短。尽管如此，仍有大量患者经历了长时间的药物暴露，尤其是治疗神经系统疾病或心血管疾病的药物。