Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands, as any bias introduced at the outset of the clinical trial would cascade down to the analysis and eventually the reporting of the results. The common study designs for oncology drugs, their challenges, the current perspectives (and dilemmas) in the industry on choosing the right endpoints/estimands, design and reporting biases, and the roles of medical writers in facing these challenges are discussed in this article.
{"title":"To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting","authors":"Z. Lee","doi":"10.56012/ejyj3404","DOIUrl":"https://doi.org/10.56012/ejyj3404","url":null,"abstract":"Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands, as any bias introduced at the outset of the clinical trial would cascade down to the analysis and eventually the reporting of the results. The common study designs for oncology drugs, their challenges, the current perspectives (and dilemmas) in the industry on choosing the right endpoints/estimands, design and reporting biases, and the roles of medical writers in facing these challenges are discussed in this article.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46346333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process","authors":"S. Shenoy","doi":"10.56012/eoag8863","DOIUrl":"https://doi.org/10.56012/eoag8863","url":null,"abstract":"","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46910497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review processes along with different stakeholders. Poor peer review leads to protocol amendments, which delay regulatory submission and increase project costs. Thus, there is a strong need for RMWs and stakeholders to work together during the peer review process to highlight the specific issues that should be addressed before finalisation, which helps in creating effective, efficient, and high-quality protocols. The suggested protocol peer review steps described in this article will help an RMW to plan, coordinate, and deliver this highly important document for global and local clinical trials.
{"title":"Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists","authors":"Kishor Patil, Chandra Kumar, S. Yao","doi":"10.56012/fbfu9448","DOIUrl":"https://doi.org/10.56012/fbfu9448","url":null,"abstract":"Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review processes along with different stakeholders. Poor peer review leads to protocol amendments, which delay regulatory submission and increase project costs. Thus, there is a strong need for RMWs and stakeholders to work together during the peer review process to highlight the specific issues that should be addressed before finalisation, which helps in creating effective, efficient, and high-quality protocols. The suggested protocol peer review steps described in this article will help an RMW to plan, coordinate, and deliver this highly important document for global and local clinical trials.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46117835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency","authors":"Morgane Colin de Verdiere, Catriona J Ester","doi":"10.56012/grep1078","DOIUrl":"https://doi.org/10.56012/grep1078","url":null,"abstract":"","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44671016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components as rescue tools during the COVID-19 pandemic to including them as integrated decentralised research methods. To date, there is no consolidated guidance for what DCT component content should be included in the protocol. To enhance clarity, completeness, and replicability in clinical trial protocols incorporating DCT components, this article outlines a simple scoping process for information gathering and summarises some common considerations around frequently used components. The objective of this article is to provide protocol authors with tools, resources, and guidance to better support the development of clinical trial protocols that include DCT components.
{"title":"Bringing decentralised clinical trial protocols to life","authors":"Jonathan Mackinnon","doi":"10.56012/rtqr5570","DOIUrl":"https://doi.org/10.56012/rtqr5570","url":null,"abstract":"Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components as rescue tools during the COVID-19 pandemic to including them as integrated decentralised research methods. To date, there is no consolidated guidance for what DCT component content should be included in the protocol. To enhance clarity, completeness, and replicability in clinical trial protocols incorporating DCT components, this article outlines a simple scoping process for information gathering and summarises some common considerations around frequently used components. The objective of this article is to provide protocol authors with tools, resources, and guidance to better support the development of clinical trial protocols that include DCT components.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48093921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Welly boots and spreadsheets: A rough guide to production animal medicine for medical writers","authors":"Rhona Fraser","doi":"10.56012/bcth6513","DOIUrl":"https://doi.org/10.56012/bcth6513","url":null,"abstract":"","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46739309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Medical writing books on a budget","authors":"A. McIntosh","doi":"10.56012/xdlz5368","DOIUrl":"https://doi.org/10.56012/xdlz5368","url":null,"abstract":"","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45377285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and collab orative. The EU CTR aims to harmonise clinical trial applications in the EU, bring more innovation to Europe, and enable faster approval of clinical trials. However, the novel process of clinical trial application in its early stages is fraught with technical and logistic challenges.
{"title":"Transition to the EU Clinical Trials Regulation: Trick or treat?","authors":"I. Turek","doi":"10.56012/wfqf7348","DOIUrl":"https://doi.org/10.56012/wfqf7348","url":null,"abstract":"The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and collab orative. The EU CTR aims to harmonise clinical trial applications in the EU, bring more innovation to Europe, and enable faster approval of clinical trials. However, the novel process of clinical trial application in its early stages is fraught with technical and logistic challenges.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47158814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory documents for conducting clinical trials in the EAEU region.
{"title":"Clinical trials in the Eurasian Economic Union","authors":"E. Radkova, I. Petrova","doi":"10.56012/odis4682","DOIUrl":"https://doi.org/10.56012/odis4682","url":null,"abstract":"In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory documents for conducting clinical trials in the EAEU region.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49267680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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