Petra Naster’s Post

𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐏𝐚𝐩𝐞𝐫𝐬 𝐄𝐱𝐩𝐥𝐚𝐢𝐧𝐞𝐝 – 𝐟𝐢𝐫𝐬𝐭 𝐩𝐚𝐩𝐞𝐫 𝐭𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐞𝐝! “𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞𝐬 𝐨𝐟 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬 𝐢𝐧 𝐡𝐨𝐦𝐞𝐬 𝐚𝐧𝐝 𝐥𝐨𝐜𝐚𝐥 𝐬𝐞𝐭𝐭𝐢𝐧𝐠𝐬 𝐨𝐮𝐭𝐬𝐢𝐝𝐞 𝐨𝐟 𝐜𝐥𝐢𝐧𝐢𝐜𝐬 – 𝐚 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐩𝐫𝐨𝐣𝐞𝐜𝐭 𝐮𝐬𝐢𝐧𝐠 𝐢𝐧𝐭𝐞𝐫𝐯𝐢𝐞𝐰𝐬” WP CODE has recently formed a working group to translate technical/scientific documents into plain language for the general public including patients. It’s intended for those interested in learning more about decentralised clinical trials (DCT) in a more accessible and easily digestible format. The aim of this group is to foster accessibility of the Trials@Home materials, to increase awareness and educational opportunities surrounding DCTs. The group has now finished the translation of the first paper “Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders” Download the translation here -> https://bit.ly/3Xz5vdz

What an amazing tool to identify & segment your Thought Leaders for field engagement, speakers' bureau, conference / journal strategy, & much more! Anywhere in the product lifecycle you can benchmark, plan, execute, and measure your TL engagement and activities. Let's chat...

What an amazing tool to identify & segment your Thought Leaders for field engagement, speakers' bureau, conference / journal strategy, & much more! Anywhere in the product lifecycle you can benchmark, plan, execute, and measure your TL engagement and activities. Let's chat...

A 🅲🅻🅸🅽🅸🅲🅰🅻 🆂🆃🆄🅳🆈 involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Most preclinical and all clinical studies require Institutional Review Board (IRB) approval, description of authority granting approval, and reference number for regulatory approval. 𝙴𝚝𝚑𝚒𝚌𝚊𝚕 𝚌𝚕𝚒𝚗𝚒𝚌𝚊𝚕 𝚛𝚎𝚜𝚎𝚊𝚛𝚌𝚑 𝚊𝚋𝚒𝚍𝚎𝚜 𝚋𝚢 𝟽 𝚖𝚊𝚒𝚗 𝚙𝚛𝚒𝚗𝚌𝚒𝚙𝚕𝚎𝚜: 1. Sᴏᴄɪᴀʟ ᴀɴᴅ ᴄʟɪɴɪᴄᴀʟ ᴠᴀʟᴜᴇ—enhancements of health or knowledge must be derived from the research. 2. Sᴄɪᴇɴᴛɪꜰɪᴄ ᴠᴀʟɪᴅɪᴛʏ—the research must be methodologically rigorous. 3. Fᴀɪʀ ꜱᴜʙᴊᴇᴄᴛ ꜱᴇʟᴇᴄᴛɪᴏɴ—scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects. 4. Fᴀᴠᴏʀᴀʙʟᴇ ʀɪꜱᴋ-ʙᴇɴᴇꜰɪᴛ ʀᴀᴛɪᴏ—within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks. 5. Iɴᴅᴇᴘᴇɴᴅᴇɴᴛ ʀᴇᴠɪᴇᴡ—unaffiliated individuals must review the research and approve, amend, or terminate it. 6. Iɴꜰᴏʀᴍᴇᴅ ᴄᴏɴꜱᴇɴᴛ—individuals should be informed about the research and provide their voluntary consent. 7. Rᴇꜱᴘᴇᴄᴛ ꜰᴏʀ ᴘᴏᴛᴇɴᴛɪᴀʟ ᴀɴᴅ ᴇɴʀᴏʟʟᴇᴅ ꜱᴜʙᴊᴇᴄᴛꜱ—subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. #scientificwriting #academicpublishing #peereviewweek European Medical Writers Association (EMWA) JAMA Source: Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA. 2000;283(20):2701–2711. doi:10.1001/jama.283.20.2701

🤔❓ Got questions about your research? CTSI Regulatory and Recruitment Facilitators are available the first Tuesday of every month from 1-2pm for quick clinical research inquiries. 👀🔗 Keep an eye out for the live meeting link on October 1st!

🌍 Thrilled to share our latest paper "EU HTA Joint Clinical Assessment: are patients with rare disease going to lose out?" 🎉 In this publication, my brilliant LCP Health Analytics teammates Alex Castanon, Rebecca Sloan, Sreeram Ramagopalan, and I comment on how the EU Regulation on Health Technology Assessment (EU HTA) could influence treatment access for rare disease patients. Because of their low prevalence, developing treatments for these conditions is incredibly challenging but crucial. We highlight a significant concern: the recently released EU HTA guidance on indirect comparisons may ignore comparative evidence provided by external control arms (and in particular those derived using real-world evidence (RWE)). This is at odds with the approach taken by other HTA bodies such as NICE, and misunderstands the challenges of drug development in these patient populations. By not performing a joint clinical assessment when only RWE is available for comparative analyses, individual countries may follow their own processes leading to inequalities in patient access to treatment across Europe, undermining the goals of EU HTA. We argue for a more pragmatic approach in EU HTA guidance to balance evidential uncertainties with the need for patient access to vital treatments. 🔗 EU HTA Joint Clinical Assessment: are patients with rare disease going to lose out? (becarispublishing.com) Excited to hear your thoughts! #HealthTechnologyAssessment #RareDiseases #RealWorldEvidence #EUHTA #ClinicalResearch #ExternalControlArms

❓ MedComms colleagues--Have you ever wanted to improve the Scientific Communication Platforms (SCP) you work on or use, but weren't sure where to begin? 🔍 I'm participating in a research project to learn more about SCP challenges and best practices across the industry. I kindly invite MedComms/medical publications professionals to complete our survey: https://lnkd.in/eqFeru-4 🌟 The results of the survey will inform an abstract to be submitted to the ISMPP (International Society for Medical Publication Professionals) Annual Meeting in Washington, DC (May 2025). We hope the insights we gather will help us learn what works well (and what doesn't) for efficient and successful SCP design and implementation! Thanks to all who complete the survey! All responses will be anonymous and individual data will not be shared. This survey presented is the work of the individual authors and does not necessarily represent the position of ISMPP.

🌟 Exciting Announcement from ClinMastery! 🌟 🔍 Are you curious about clinical research? Eager to learn more about the ins and outs of navigating this dynamic field? Look no further! 🎉 We're thrilled to announce that ClinMastery will be hosting a live Q&A session dedicated to answering all your burning questions about clinical research. 🗓️ Mark your calendars! Join us on [date] at [time] [timezone] for an engaging discussion where you can get insights directly from seasoned experts in the field. 💡 Wondering about study design, participant recruitment, ethical considerations, or anything else related to clinical research? This is your chance to get answers! 📝 Here's how to participate: 1️⃣ Simply drop your questions in the comments below this post. 2️⃣ Tune in to our live session on [date] to hear your questions answered by our knowledgeable panelists. 🚀 Let's come together to explore the fascinating world of clinical research and empower each other on our research journeys. 👉 Don't miss out! Submit your questions now and stay tuned for more details about our upcoming Q&A session. #ClinicalResearch #QandA #ResearchCommunity #ClinMastery #AskYourQuestions #MedicalResearch #HealthcareScience #ResearchMethods #ClinicalTrials #EvidencedBasedMedicine #HealthScience #ResearchCommunity #PublicHealthResearch #BiomedicalResearch #ClinicalStudies #ClinicalData #ResearchEthics #PatientEngagement #TranslationalResearch #HealthTechResearch #ResearchCollaboration #ResearchInnovation #ScientificDiscovery #DataAnalysis

Don't miss our roundtable session at the 20th Annual Meeting of ISMPP (International Society for Medical Publication Professionals)! 🔍 Roundtable Session: Achieving excellence in simultaneous congress presentation and high-tier journal publication: what the publication professional needs to know 🗓️ April 30, 2024 🕓 4:00 PM – 4:45 PM Developing abstracts and manuscripts of pivotal data with the aim of publication in a high-tier journal at the same time as congress presentation is usually done to very tight timelines and under quite challenging conditions. In this roundtable session, we will be exploring the intricacies of developing abstracts and manuscripts of pivotal data alongside congress presentations. This will provide the opportunity for discussion with industry experts on navigating tight timelines, complex guidelines, and embargo restrictions. Join this session if you are embarking on your first simultaneous publication and would like to gain valuable insights or would like to talk through your own experiences and gain additional knowledge. We hope to see you there! #PublicationStrategies #BestPractices #ISMPPAnnual2024 #PrimeAtISMPP #MedicalPublications

📄 Module 6: The Research Protocol in Clinical Research 📄 Continuing my journey through the clinical research field, Module 6 offered essential insights into the structure and importance of the research protocol. Here's an overview of the key learnings: 🔍 Part 1: Introduction Understanding the foundational role of the research protocol in clinical studies is crucial. It serves as the blueprint for conducting research ethically and effectively. 📝 Part 2: Contents of the Research Protocol (ICH E3 GCP 6) Exploring the comprehensive contents of the research protocol as outlined in ICH E3 GCP 6 highlighted the need for detailed planning. Clear objectives, methodologies, and ethical considerations are vital components. 🔄 Part 3: What is a Protocol Amendment? Learning about protocol amendments emphasized the dynamic nature of clinical research. Flexibility and responsiveness are key, as amendments ensure the protocol remains relevant and effective in light of new information or challenges. 🚫 Part 4: What is a Protocol Violation? Understanding protocol violations underscored the importance of adherence to the research plan. Identifying and addressing violations promptly is essential to maintain the integrity and validity of the study. Module 6 reinforced the critical role of the research protocol in guiding clinical studies and ensuring adherence to ethical and scientific standards. Let's collaborate to share best practices and enhance our protocol management strategies. #ClinicalResearchProtocol #ResearchMethodology #ClinicalTrialDesign #ClinicalStudyProtocol #DataCollectionProcess #EthicalConsiderations #MedicalResearchStandards