Artificial intelligence (AI) is beginning to affect almost every industry, and medical writing is no different. But how does this relate to our industry? How will AI affect medical writers? What’s already available and what is in the pipeline? Should medical writers be happy and embrace the technology, or should we resist as much as we can, assuming that we will all be replaced by machines? This article discusses the current state of the art of AI in medical writing and asks the question: AI for medical writers – friend or foe?
{"title":"AI for medical writers: Friend or foe?","authors":"Jamie Norman, Lisa Chamberlain James","doi":"10.56012/qovt1204","DOIUrl":"https://doi.org/10.56012/qovt1204","url":null,"abstract":"Artificial intelligence (AI) is beginning to affect almost every industry, and medical writing is no different. But how does this relate to our industry? How will AI affect medical writers? What’s already available and what is in the pipeline? Should medical writers be happy and embrace the technology, or should we resist as much as we can, assuming that we will all be replaced by machines? This article discusses the current state of the art of AI in medical writing and asks the question: AI for medical writers – friend or foe?","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136099758","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}
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to ensure safe and effective use. This article explores the utilisation and opportunities in three areas: medical devices (built in software applications); post-marketing surveillance (processing of large volumes of reported adverse reactions); and clinical development (pharmacokinetic profile, dose selection, clinical trial design, and regulatory writing). AI/ML-based applications are not perfect. Potential risks are enormous. Continued public/private engagement, vigilance, and oversight for all parties is essential for successful utilisation of these tools.
{"title":"Regulatory initiatives for artificial intelligence applications: Regulatory writing implications","authors":"Anjana Bose","doi":"10.56012/kdyv1106","DOIUrl":"https://doi.org/10.56012/kdyv1106","url":null,"abstract":"Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to ensure safe and effective use. This article explores the utilisation and opportunities in three areas: medical devices (built in software applications); post-marketing surveillance (processing of large volumes of reported adverse reactions); and clinical development (pharmacokinetic profile, dose selection, clinical trial design, and regulatory writing). AI/ML-based applications are not perfect. Potential risks are enormous. Continued public/private engagement, vigilance, and oversight for all parties is essential for successful utilisation of these tools.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136099764","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 transparency and disclosure landscape in Asia has been rapidly evolving during the past decade. With respect to clinical trial registries, China launched its national registry, ChinaDrugTrials.org.cn, in 2013; South Korea introduced the new clinical trial disclosure platform through its Ministry of Food and Drug Safety (MFDS) in 2019; whilst Japan unified its three existing primary registries into a single clinical trial registry – Japan Registry of Clinical Trials (jRCT) – in 2020. We provide an overview of the national clinical trial registries and the trial results disclosure practices for 4 Asian countries – China, Japan, South Korea, and Taiwan.
{"title":"Current clinical trial disclosure landscape in Asia","authors":"Zuo Yen Lee","doi":"10.56012/vxbm4667","DOIUrl":"https://doi.org/10.56012/vxbm4667","url":null,"abstract":"The transparency and disclosure landscape in Asia has been rapidly evolving during the past decade. With respect to clinical trial registries, China launched its national registry, ChinaDrugTrials.org.cn, in 2013; South Korea introduced the new clinical trial disclosure platform through its Ministry of Food and Drug Safety (MFDS) in 2019; whilst Japan unified its three existing primary registries into a single clinical trial registry – Japan Registry of Clinical Trials (jRCT) – in 2020. We provide an overview of the national clinical trial registries and the trial results disclosure practices for 4 Asian countries – China, Japan, South Korea, and Taiwan.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136099768","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 preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.
{"title":"Clinical Data Publication (Policy 0070) relaunch","authors":"Alison McIntosh","doi":"10.56012/nnwx9514","DOIUrl":"https://doi.org/10.56012/nnwx9514","url":null,"abstract":"In preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136100501","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}
Guest Editors Daniela Kamir and Shiri Diskin provide an introduction to this issue, whose theme Artificial Intelligence and Machine Learning. We are in an era in which most people cannot imagine living without either computers or smartphones. We are well aware of how machine learning (ML) and artificial intelligence (AI) tools support our daily lives. And now, with their rapid development, medical writers can leverage these technologies to enhance productivity, quality, and innovation. The idea for a Medical Writing issue focusing on automation in medical writing arose about 2 years ago. This was quite a few months before ChatGPT became a household term, and the tool itself went swiftly into use with almost every copy-editing professional, every lawyer, and every person in any industry that uses text as their main tool of the trade. We were very interested in taking a snapshot of the landscape of tools that are currently available to medical writers and how they are being used.
{"title":"Artificial Intelligence and Machine Learning","authors":"Daniela Kamir, Shiri Diskin","doi":"10.56012/vrpa5453","DOIUrl":"https://doi.org/10.56012/vrpa5453","url":null,"abstract":"Guest Editors Daniela Kamir and Shiri Diskin provide an introduction to this issue, whose theme Artificial Intelligence and Machine Learning. We are in an era in which most people cannot imagine living without either computers or smartphones. We are well aware of how machine learning (ML) and artificial intelligence (AI) tools support our daily lives. And now, with their rapid development, medical writers can leverage these technologies to enhance productivity, quality, and innovation. The idea for a Medical Writing issue focusing on automation in medical writing arose about 2 years ago. This was quite a few months before ChatGPT became a household term, and the tool itself went swiftly into use with almost every copy-editing professional, every lawyer, and every person in any industry that uses text as their main tool of the trade. We were very interested in taking a snapshot of the landscape of tools that are currently available to medical writers and how they are being used.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136099747","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}
Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory assessment. Reporting M&S analyses can be technically challenging given the large amount of input and output data that need to be summarised and accurately described in regulated reports. Therefore, reproducibility, automation, traceability, and standardisation are considered key aspects of this process. We present here a system that, using a combination of software, meets these challenges and improves the efficiency, accuracy, and reliability of our work.
{"title":"Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics","authors":"Viviana Moroso, Mats Magnusson, E. Niclas Jonsson","doi":"10.56012/wmqy8556","DOIUrl":"https://doi.org/10.56012/wmqy8556","url":null,"abstract":"Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory assessment. Reporting M&S analyses can be technically challenging given the large amount of input and output data that need to be summarised and accurately described in regulated reports. Therefore, reproducibility, automation, traceability, and standardisation are considered key aspects of this process. We present here a system that, using a combination of software, meets these challenges and improves the efficiency, accuracy, and reliability of our work.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136099760","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":"Systems biology and real-world data as drivers of change in drug research and development","authors":"A. Sivananthan","doi":"10.56012/awvf3242","DOIUrl":"https://doi.org/10.56012/awvf3242","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":"43849948","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}
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated to the rare disease context, manufacturing and supply issues, and safety and financial risks. Here, we discuss some of these potential challenges and how, through proactive early engagement with key opinion leaders, regulatory bodies, and patient groups, a cohesive and strategic clinical development plan can be created to provide the strongest foundations when marketing approval is sought.
{"title":"The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective","authors":"S. Milner, A. Kusmierczyk, Julie Taccoen","doi":"10.56012/cwaa8066","DOIUrl":"https://doi.org/10.56012/cwaa8066","url":null,"abstract":"Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated to the rare disease context, manufacturing and supply issues, and safety and financial risks. Here, we discuss some of these potential challenges and how, through proactive early engagement with key opinion leaders, regulatory bodies, and patient groups, a cohesive and strategic clinical development plan can be created to provide the strongest foundations when marketing approval is sought.","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":"44396810","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 European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data of EU citizens. Medical writing includes the development of documents related to clinical research. To develop those documents, medical writers have access to personal data, including health information considered as sensitive data. Therefore, medical writing falls within the purview of GDPR and must comply with its requirements. This article is an overview of the impact of GDPR on medical writing including security measures such as anonymisation, pseudonymisation, and data minimisation techniques. It also provides an overview of the technical and organisational actions in the framework of medical writing to guarantee respect of data subjects’ rights and freedoms.
{"title":"Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials","authors":"Tatiana Revenco, Gregory Collet","doi":"10.56012/ivhe5802","DOIUrl":"https://doi.org/10.56012/ivhe5802","url":null,"abstract":"The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data of EU citizens. Medical writing includes the development of documents related to clinical research. To develop those documents, medical writers have access to personal data, including health information considered as sensitive data. Therefore, medical writing falls within the purview of GDPR and must comply with its requirements. This article is an overview of the impact of GDPR on medical writing including security measures such as anonymisation, pseudonymisation, and data minimisation techniques. It also provides an overview of the technical and organisational actions in the framework of medical writing to guarantee respect of data subjects’ rights and freedoms.","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":"42163501","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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