真实世界的研究和随机对照试验：播客讨论这些补充性设计在癌症研究中的相对优势和局限性。

IF 3.2 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2025-09-11 DOI:10.1007/s40487-025-00368-w

Adam Brufsky, Christos Vaklavas, Joanne C Ryan

{"title":"真实世界的研究和随机对照试验：播客讨论这些补充性设计在癌症研究中的相对优势和局限性。","authors":"Adam Brufsky, Christos Vaklavas, Joanne C Ryan","doi":"10.1007/s40487-025-00368-w","DOIUrl":null,"url":null,"abstract":"Randomized controlled trials (RCTs) are the benchmark for assessing the safety and efficacy of treatments but are subject to some inherent limitations, such as restrictive inclusion criteria and underrepresentation of certain patient groups. Studies based on diverse real-world data sources provide complementary evidence that can help fill knowledge gaps, particularly by providing safety and outcome data for patients not typically included in RCTs. However, real-world data studies have their own limitations. This podcast aims to be a resource for clinicians by exploring the strengths and limitations of RCTs and real-world studies in the context of cancer research. The hosts, both of whom are practicing oncologists, provide context for the emergence of modern real-world studies and advice for interpreting real-world evidence. As a supplement to learnings from RCTs, real-world evidence can inform the treatment decision-making process in the clinic and support decisions made by regulatory bodies. This podcast is part 1 of a three-part series discussing real-world studies.Podcast and infographic available for this article. Podcast video (MP4 66494 KB).","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Studies and Randomized Controlled Trials: A Podcast Discussion of the Relative Strengths and Limitations of These Complementary Designs for Cancer Research.\",\"authors\":\"Adam Brufsky, Christos Vaklavas, Joanne C Ryan\",\"doi\":\"10.1007/s40487-025-00368-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Randomized controlled trials (RCTs) are the benchmark for assessing the safety and efficacy of treatments but are subject to some inherent limitations, such as restrictive inclusion criteria and underrepresentation of certain patient groups. Studies based on diverse real-world data sources provide complementary evidence that can help fill knowledge gaps, particularly by providing safety and outcome data for patients not typically included in RCTs. However, real-world data studies have their own limitations. This podcast aims to be a resource for clinicians by exploring the strengths and limitations of RCTs and real-world studies in the context of cancer research. The hosts, both of whom are practicing oncologists, provide context for the emergence of modern real-world studies and advice for interpreting real-world evidence. As a supplement to learnings from RCTs, real-world evidence can inform the treatment decision-making process in the clinic and support decisions made by regulatory bodies. This podcast is part 1 of a three-part series discussing real-world studies.Podcast and infographic available for this article. Podcast video (MP4 66494 KB).\",\"PeriodicalId\":44205,\"journal\":{\"name\":\"Oncology and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-09-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oncology and Therapy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40487-025-00368-w\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oncology and Therapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40487-025-00368-w","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

随机对照试验（rct）是评估治疗安全性和有效性的基准，但存在一些固有的局限性，例如限制性的纳入标准和某些患者群体的代表性不足。基于各种真实数据来源的研究提供了补充证据，可以帮助填补知识空白，特别是通过为通常未纳入随机对照试验的患者提供安全性和结局数据。然而，现实世界的数据研究有其自身的局限性。本播客旨在通过探索随机对照试验和现实世界研究在癌症研究背景下的优势和局限性，为临床医生提供资源。两位主持人都是执业肿瘤学家，他们为现代现实世界研究的出现提供了背景，并为解释现实世界的证据提供了建议。作为随机对照试验的补充，真实世界的证据可以为临床治疗决策过程提供信息，并支持监管机构做出的决策。本播客是讨论现实世界研究的三部分系列的第一部分。本文提供播客和信息图表。播客视频（MP4 66494 KB）。

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

Real-World Studies and Randomized Controlled Trials: A Podcast Discussion of the Relative Strengths and Limitations of These Complementary Designs for Cancer Research.

Randomized controlled trials (RCTs) are the benchmark for assessing the safety and efficacy of treatments but are subject to some inherent limitations, such as restrictive inclusion criteria and underrepresentation of certain patient groups. Studies based on diverse real-world data sources provide complementary evidence that can help fill knowledge gaps, particularly by providing safety and outcome data for patients not typically included in RCTs. However, real-world data studies have their own limitations. This podcast aims to be a resource for clinicians by exploring the strengths and limitations of RCTs and real-world studies in the context of cancer research. The hosts, both of whom are practicing oncologists, provide context for the emergence of modern real-world studies and advice for interpreting real-world evidence. As a supplement to learnings from RCTs, real-world evidence can inform the treatment decision-making process in the clinic and support decisions made by regulatory bodies. This podcast is part 1 of a three-part series discussing real-world studies.Podcast and infographic available for this article. Podcast video (MP4 66494 KB).

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

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of clinical therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital features and plain language summaries Oncology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles 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 the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor. Copyright Oncology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0 Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis. Open Access All articles published by Oncology and Therapy are published open access Contact For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.