A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials.
A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials.
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一项荟萃研究揭示了为研究者发起的药物试验获取安慰剂的几个挑战。
DOI：
10.1016/j.jclinepi.2020.11.007
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发表时间：
2021
影响因子：
7.2
通讯作者：
Speich B
中科院分区：
文献类型：
--
作者：
Speich B
目的系统评估安慰剂在药物启动的随机对照试验（RCT）中的使用类型、来源以及获得这些安慰剂的障碍。研究设计和设置检索PubMed最近发表的非商业性、安慰剂对照的随机药物试验。通讯作者应邀参加了一项在线调查。结果在423篇符合条件的文章中，109（26%）名通讯作者（部分）参与了研究。102名作者中有21名（21%）报告使用的安慰剂不匹配（仅在一篇出版物中正确标记）。获得安慰剂的主要来源是医院药房（32/107; 30%）和研究药物生产商（28/107; 26%）。假设研究药物制造商利益的RCT更有可能从药物制造商处获得安慰剂（18/49; 37% vs. 5/29; 17%）。安慰剂和包装的中位成本为58，286美元（IQR 2，428美元-160，770美元; n= 24），占总试验预算的中位值10.3%。结论尽管使用匹配的安慰剂被广泛接受为RCT的基本实践，但似乎没有标准的来源来获取它们。获得安慰剂需要大量的资源，并且使用不匹配的安慰剂是常见的。
Objectives To systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), from where they are obtained, and the hurdles that exist in obtaining them. Study Design and Setting PubMed was searched for recently published noncommercial, placebo-controlled randomized drug trials. Corresponding authors were invited to participate in an online survey. Results From 423 eligible articles, 109 (26%) corresponding authors (partially) participated. Twenty-one of 102 (21%) authors reported that the placebos used were not matching (correctly labeled in only one publication). The main sources in obtaining placebos were hospital pharmacies (32 of 107; 30%) and the manufacturer of the study drug (28 of 107; 26%). RCTs with a hypothesis in the interest of the manufacturer of the study drug were more likely to have obtained placebos from the drug manufacturer (18 of 49; 37% vs. 5 of 29; 17%). Median costs for placebos and packaging were US $58,286 (IQR US $2,428–US $160,770; n= 24), accounting for a median of 10.3% of the overall trial budget. Conclusion Although using matching placebos is widely accepted as a basic practice in RCTs, there seems to be no standard source to acquire them. Obtaining placebos requires substantial resources, and using nonmatching placebos is common.
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