预注册：可信真实世界证据生成的关键。

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-09-01 DOI:10.1002/pds.70215

Emma Simonsen, Shirley V Wang, Helene Kildegaard, Anton Pottegård

{"title":"预注册：可信真实世界证据生成的关键。","authors":"Emma Simonsen, Shirley V Wang, Helene Kildegaard, Anton Pottegård","doi":"10.1002/pds.70215","DOIUrl":null,"url":null,"abstract":"Background: Preregistration of study protocols in a public repository promotes transparency and reproducibility in pharmacoepidemiological research. Despite its clear benefits, preregistration remains underutilized.Purpose: Here, we discuss the advantages of preregistration, explore barriers to its implementation, and highlight existing repositories for preregistering real-world evidence study protocols. A relatively new option is the Real-World Evidence Registry within the Open Science Framework (OSF), which we briefly introduce.","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70215"},"PeriodicalIF":2.4000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397443/pdf/","citationCount":"0","resultStr":"{\"title\":\"Preregistration: A Key to Credible Real-World Evidence Generation.\",\"authors\":\"Emma Simonsen, Shirley V Wang, Helene Kildegaard, Anton Pottegård\",\"doi\":\"10.1002/pds.70215\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: Preregistration of study protocols in a public repository promotes transparency and reproducibility in pharmacoepidemiological research. Despite its clear benefits, preregistration remains underutilized.Purpose: Here, we discuss the advantages of preregistration, explore barriers to its implementation, and highlight existing repositories for preregistering real-world evidence study protocols. A relatively new option is the Real-World Evidence Registry within the Open Science Framework (OSF), which we briefly introduce.\",\"PeriodicalId\":19782,\"journal\":{\"name\":\"Pharmacoepidemiology and Drug Safety\",\"volume\":\"34 9\",\"pages\":\"e70215\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397443/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pds.70215\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70215","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

背景：在公共存储库中预先注册研究方案可促进药物流行病学研究的透明度和可重复性。尽管有明显的好处，但预登记仍未得到充分利用。目的：在这里，我们讨论了预注册的优势，探讨了其实施的障碍，并强调了预注册现实世界证据研究方案的现有存储库。一个相对较新的选择是开放科学框架（OSF）中的真实世界证据注册，我们简要介绍一下。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Preregistration: A Key to Credible Real-World Evidence Generation.

Background: Preregistration of study protocols in a public repository promotes transparency and reproducibility in pharmacoepidemiological research. Despite its clear benefits, preregistration remains underutilized.

Purpose: Here, we discuss the advantages of preregistration, explore barriers to its implementation, and highlight existing repositories for preregistering real-world evidence study protocols. A relatively new option is the Real-World Evidence Registry within the Open Science Framework (OSF), which we briefly introduce.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.