[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-164847-en":3,"doc-seo-164847-105":30,"detail-sidebar-cat-1-en-105":83},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":11,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},164847,1374391974564,"Clementine","https://ap-avatar.wpscdn.com/avatar/14000253aa45c000a9e?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779874745381141002",1,11,"Presentations","Considerations for Health Technology Assessment Transparency - How Much Is Too Much","The session examines health technology assessment (HTA) confidentiality guidance and the practical limits of clinical data transparency. It explains how industry and HTA stakeholders can align around openness while protecting patient access and ensuring discoverability of research through open-access publication practices. Key tensions include workload impacts on companies, the scope of secondary data requests, and publication-ready requirements for global teams. Evidence on publication timelines is used to discuss whether more disclosure improves outcomes without creating avoidable risks or additional quality-control burden.","Considerations from an Industry RepresentativeIoannis PetrakisR&D, Global Program LeaderTakeda Gastrointestinal and Inflammation therapeutic area\nISPOR 2023\nSession ‒ Transparency in Health\nTechnology Assessment: how much is too much?\nIntroduction\n2\nHTA, health technology assessment; NICE, National Institute for Health and Care Excellence; ICMJE, International Committee of Medical Journal Editors.\nWe welcome the joint venture between HTAs, patients and Industry to contribute to the public dialogue around the process of confidentiality and clinical data transparency\nWe thank NICE for bringing together stakeholders to discuss this important topic\nIdeally, changes to the confidentiality guidance from HTAs will reduce workload burden on both HTA bodies and Pharmaceutical Industry, whilst striving for timely and appropriate information sharing with the patient community\nWorking in partnership in implementing changes\nWe would like to take this opportunity to highlight some considerations\nWe all share the same intentions around data transparency to advance science and help patients, while protecting patient access. While introducing change, we need to observe how ICMJE statement will be implemented and what other risks may arise\nImportant note\nAll opinions and information herein are mine and may not necessarily represent the position of my company, including its affiliates in the UK, the USA and Canada, or any other Pharmaceutical Industry association or member across the world\nFirstly ‒ our company is committed to publishing all clinical data in open access format\n3\na Available at, https://www.takeda.com/en-gb/corporate-responsibility/transparency-disclosures/clinical-trials-and-results; b Takeda standards, Data on File.\nCT, clinical trial; EFPIA, European Federation of Pharmaceutical Industries; PhRMA, Pharmaceutical Research and Manufacturers of America; STM, Scientific, Technical and Medical.\nTakeda Clinical Study Transparency Policya\n“Takeda is committed to transparency and integrity in its clinical research.”\n“Takeda has been and continues to be committed to complying with all laws and regulations related to the registration and disclosure of Takeda-sponsored clinical study information.\n“Takeda is dedicated to the timely registration of clinical studies, communication of clinical study result summaries, and publication of our company sponsored clinical research.”\n“Takeda supports pharmaceutical industry's joint initiatives relating to increased clinical trial transparency”\nWe include relevant statements upon submission of CT manuscripts to a journal for publicationb\n“Takeda’s commitment to transparency and the discoverability and accessibility of Takeda research, all STM manuscripts resulting from Takeda-sponsored research, regardless of research type, audience, and language, are required to be submitted to journals that offer public availability via Open Access”\n“The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants data supporting the results reported in this article, will be made available within three months from the initial request, to researchers who provide a methodological sound proposal. The data will be provided after its de-identification in compliance with applicable privacy laws, data protection and requirements for consent and anonymization.”\nTakeda only publishes in Open Access Journalsb\nSecondary data requests may hinder HTA submissions due to company workload and “negotiations” between requesting affiliate and data owner\nPost-hoc/exploratory analyses, new RWD analysis, unplanned subgroups, PSP data etc.\nGlobal teams will need to complete all analyses in a publication ready manner\nHTA bodies frequently request further clinical data analyses\nAIC, academic in confidence; CI, confidence interval; CIC, commercial in confidence; CSR Clinical Study Report; HTA, health technology assessment; IQR, interquartile range; PSP, Patient Support Program; QC, qualit","cbCaid4j2rZeZ3Ms","https://ap.wps.com/l/cbCaid4j2rZeZ3Ms","pptx",444038,8,"English","en",105,"# Introduction\n## Key stakeholder intent: transparency with patient protection\n# Important note: scope of opinions\n# Takeda transparency policy and publication commitments\n## Open-access journal requirement\n## Timely registration, result summaries, and dataset access\n# Impact of data requests on HTA submissions\n## Academic vs commercial in confidence\n## Secondary requests and post-hoc analyses\n# Publication timeline evidence\n# When confidentiality helps—and what it cannot solve","[{\"question\":\"Does confidentiality guidance fully eliminate additional publication and quality control work?\",\"answer\":\"No. In most cases confidentiality helps simplify release, but it does not remove publication-planning and quality-control requirements that can still arise from additional analyses.\"}]","Considerations for Health Technology Assessment Transparency - How Much Is Too Much | PPTX",1788162274,3,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":78,"head_meta":80,"extra_data":82,"updated_unix":28},"considerations-for-health-technology-assessment-transparency-how-much-is-too-much","",{"@graph":36,"@context":77},[37,53,68],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,50],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":29},"https://docshare.wps.com/template/presentations/",{"item":51,"name":14,"@type":43,"position":52},"https://docshare.wps.com/template/considerations-for-health-technology-assessment-transparency-how-much-is-too-much/164847/",4,{"url":51,"name":14,"@type":54,"author":55,"headline":14,"publisher":57,"fileFormat":60,"inLanguage":23,"description":15,"dateModified":61,"datePublished":62,"encodingFormat":60,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":56},"Person",{"url":41,"name":58,"@type":59},"DocShare","Organization","application/vnd.openxmlformats-officedocument.presentationml.presentation","2026-09-02","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":52},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71],{"name":72,"@type":73,"acceptedAnswer":74},"Does confidentiality guidance fully eliminate additional publication and quality control work?","Question",{"text":75,"@type":76},"No. In most cases confidentiality helps simplify release, but it does not remove publication-planning and quality-control requirements that can still arise from additional analyses.","Answer","https://schema.org",{"og:url":51,"og:type":79,"og:title":14,"og:site_name":58,"og:description":15},"article",{"robots":81,"canonical":51},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":84},[85,88,93,98,103,108,113,118,123],{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":86,"slug":87},90,"presentations",{"id":89,"doc_module":11,"doc_module_name":46,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":11,"doc_module_name":46,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":11,"doc_module_name":46,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":11,"doc_module_name":46,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":11,"doc_module_name":46,"category_name":110,"show_sort_weight":111,"slug":112},17,"Forms",40,"forms",{"id":114,"doc_module":11,"doc_module_name":46,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":11,"doc_module_name":46,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":11,"doc_module_name":46,"category_name":125,"show_sort_weight":4,"slug":126},158,"General","general-158"]