评估药物暴露和用药依从性对评价研究药物的重要性:确保临床试验结果的有效性和可靠性。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Pharmaceutical Medicine Pub Date : 2024-01-01 Epub Date: 2023-12-22 DOI:10.1007/s40290-023-00503-w
Bernard Vrijens, Antoine Pironet, Eric Tousset
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引用次数: 0

摘要

本意见书旨在引起全球对用药依从性的关注,强调其在药物试验中的关键作用。试验人员通常采用传统方法来评估用药依从性,这种方法虽然简便易行,但可能只能揭示试验人员所希望的结果,而不能提供药物开发过程中做出明智决策所需的重要见解。在评估研究药物的有效性和安全性时,了解药物暴露和用药依从性至关重要。如果不能全面了解患者如何坚持处方治疗方案,临床试验结果的完整性和可靠性就会受到影响。本文强调了准确可靠地评估药物摄入行为的措施的必要性,以便区分轻微的剂量错误和可能影响药物疗效和安全性的重大偏差。准确了解药物暴露情况有助于研究人员做出明智决策、识别潜在的混杂因素并适当解释研究结果,最终确保研究结果的有效性和可靠性。通过优先考虑药物暴露评估和用药依从性测量,临床试验可以提高其科学严谨性,有助于对研究药物进行更准确的评估,并最终加快研发进程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results.

The objective of this current opinion paper is to draw global attention to medication adherence, emphasizing its crucial role in drug trials. Frequently, trialists lean on traditional approaches to assess medication adherence, which, while comfortable, may only reveal what trialists desire rather than offering the essential insights needed for informed decision making in drug development. Understanding drug exposure and medication adherence is paramount when evaluating the effectiveness and safety of investigational medications. Without a comprehensive understanding of how patients adhere to their prescribed treatment regimens, the integrity and dependability of clinical trial results can be compromised. This paper emphasizes the need for measures that accurately and reliably assess medication intake behaviors, enabling the differentiation between minor dosing errors and significant deviations that may impact the drug's efficacy and safety. Accurate knowledge of drug exposure empowers researchers to make informed decisions, identify potential confounding factors, and appropriately interpret study outcomes, ultimately ensuring the validity and reliability of the research findings. By prioritizing drug exposure assessment and medication adherence measurement, clinical trials can enhance their scientific rigor, contribute to more accurate evaluations of investigational medications, and ultimately speed up the development process.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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