Leonie H. E. Leithold, C. Brown, Julia Hind, T. Schindler
Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public” titles) that are understandable to the public. However, devising adequate lay titles is challenging. In this study, we assessed the quality of lay titles from Phase II/III and III clinical trials registered in ClinicalTrials.gov in 2021. Assessments included the presence of recommended elements, use of technical terms, an expert assessment of adequacy and informativeness, title length, and the use of acronyms. A large proportion (72%) of lay titles did not include all recommended elements, contained technical terms (73%), and were not adequate according to experts (51%). Often, brevity was given precedence over content and understandability. Generally, lay titles with acronyms had better ratings in all assessed categories. These results suggest that industry sponsors can do more to create lay titles that better inform patients and healthcare providers.
{"title":"Lay titles for clinical trials: Is industry achieving the balance?","authors":"Leonie H. E. Leithold, C. Brown, Julia Hind, T. Schindler","doi":"10.56012/lnhw1492","DOIUrl":"https://doi.org/10.56012/lnhw1492","url":null,"abstract":"Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public” titles) that are understandable to the public. However, devising adequate lay titles is challenging. In this study, we assessed the quality of lay titles from Phase II/III and III clinical trials registered in ClinicalTrials.gov in 2021. Assessments included the presence of recommended elements, use of technical terms, an expert assessment of adequacy and informativeness, title length, and the use of acronyms. A large proportion (72%) of lay titles did not include all recommended elements, contained technical terms (73%), and were not adequate according to experts (51%). Often, brevity was given precedence over content and understandability. Generally, lay titles with acronyms had better ratings in all assessed categories. These results suggest that industry sponsors can do more to create lay titles that better inform patients and healthcare providers.","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":"41662572","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}
This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the context of regulatory requirements in Europe and discuss which documents are connected to the Clinical Investigation Plan. Finally, we discuss the different types of clinical investigations and the current status of the Clinical Investigation and Performance Studies module of EUDAMED (European Database for Medical Devices).
{"title":"Clinical investigations for medical devices","authors":"Beatrix Doerr, Shirin Khalili, Joan D'souza","doi":"10.56012/tpkn1389","DOIUrl":"https://doi.org/10.56012/tpkn1389","url":null,"abstract":"This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the context of regulatory requirements in Europe and discuss which documents are connected to the Clinical Investigation Plan. Finally, we discuss the different types of clinical investigations and the current status of the Clinical Investigation and Performance Studies module of EUDAMED (European Database for Medical Devices).","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":"49299296","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}
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare professionals, and the public, and are used to assess the safety and efficacy of medical treatments. This article presents an overview of the steps involved in writing and submitting CSRs to regulatory authorities, as well as reporting clinical trial findings to the scientific community and the public.
{"title":"Clinical study reports: A snapshot for aspiring medical writers","authors":"Surayya Taranum","doi":"10.56012/qett4705","DOIUrl":"https://doi.org/10.56012/qett4705","url":null,"abstract":"Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare professionals, and the public, and are used to assess the safety and efficacy of medical treatments. This article presents an overview of the steps involved in writing and submitting CSRs to regulatory authorities, as well as reporting clinical trial findings to the scientific community and the public.","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":"44811981","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":"British, American, Canadian, and Australian spelling","authors":"Christa Bedwin","doi":"10.56012/vewc8324","DOIUrl":"https://doi.org/10.56012/vewc8324","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":"47010002","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 EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the requirements of the regulation with respect to the Protocol Synopsis and discusses their feasibility in light of the maximum page limit.
{"title":"The Lay Protocol Synopsis: Requirements and feasibility","authors":"Lisa Chamberlain James","doi":"10.56012/dwxn7122","DOIUrl":"https://doi.org/10.56012/dwxn7122","url":null,"abstract":"The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the requirements of the regulation with respect to the Protocol Synopsis and discusses their feasibility in light of the maximum page limit.","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":"47805787","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":"Unsung heroes: The medical writer’s role in clinical trials","authors":"R. Billiones, I. Turek","doi":"10.56012/pvjb4577","DOIUrl":"https://doi.org/10.56012/pvjb4577","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":"44055392","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}
Joanna Verran, Sam Illingworth, James Pritchett, James Redfern
Few universities offer courses in medical writing, and students from the biomedical sciences who wish to become medical writers typically need to learn written communication skills on the job. In this article, Joanna Verran and colleagues offer insights into the opportunities and challenges when establishing a Medical Writing course at postgraduate level.
{"title":"Co-development, co-delivery, and evaluation of a Medical Writing module at master’s level","authors":"Joanna Verran, Sam Illingworth, James Pritchett, James Redfern","doi":"10.56012/lbsg8046","DOIUrl":"https://doi.org/10.56012/lbsg8046","url":null,"abstract":"Few universities offer courses in medical writing, and students from the biomedical sciences who wish to become medical writers typically need to learn written communication skills on the job. In this article, Joanna Verran and colleagues offer insights into the opportunities and challenges when establishing a Medical Writing course at postgraduate level.","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":"135698478","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}
A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug development and are accordingly titled as early phase writers, late phase writers, publication writers, and so on. As writers progress in their careers, depending on each writer’s interests, they could be exposed to a plethora of documents across the writing continuum (starting from pre-clinical to post-approval phases of drug development). Writers thus have the potential to play an important role in ensuring data is disseminated to various stakeholders in a coherent and seamless manner throughout the product’s lifecycle. Let’s take a look at the various aspects to keep in mind as writers move from one document to the next and help connect the dots!
{"title":"Connecting the dots across the writing continuum","authors":"Ambika Subramanian","doi":"10.56012/feef1217","DOIUrl":"https://doi.org/10.56012/feef1217","url":null,"abstract":"A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug development and are accordingly titled as early phase writers, late phase writers, publication writers, and so on. As writers progress in their careers, depending on each writer’s interests, they could be exposed to a plethora of documents across the writing continuum (starting from pre-clinical to post-approval phases of drug development). Writers thus have the potential to play an important role in ensuring data is disseminated to various stakeholders in a coherent and seamless manner throughout the product’s lifecycle. Let’s take a look at the various aspects to keep in mind as writers move from one document to the next and help connect the dots!","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":"42026817","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}
Ernest Dzidzornu, J. Cherian, Joan D'souza, J. Pandit, Melissa Bernal, Diana Radovan
{"title":"Ecopharmacovigilance: A review of cause, impact, and remedies","authors":"Ernest Dzidzornu, J. Cherian, Joan D'souza, J. Pandit, Melissa Bernal, Diana Radovan","doi":"10.56012/rlhx7717","DOIUrl":"https://doi.org/10.56012/rlhx7717","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":"48387020","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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