A big congratulations to Honz Slipka, Certara's Senior Transparency Specialist! Thank you for sharing your expertise and insights into clinical data transparency and disclosure. Your dedication to advancing understanding in this critical area is inspiring. We’re proud to have you on the team! #TransparencyExpert #Certara #ClinicalData
As 2024 draws to a close, here is a brief summary on how clinical data are being disclosed, and how patients in clinical research are being protected. (These are aggregated data from the 52 clinical studies posted to European Medicines Agency first year of hashtag #Policy0070.) 🩺🔬🧪 ✨HYBRID THEORY✨ 🟩 The most popular approach to data protection is qualitative 𝗿𝗲𝗱𝗮𝗰𝘁𝗶𝗼𝗻. A rules-based approach that protects sensitive information with limited consideration for utility or data use. Its popularity has been decreasing. 🟩 A spike in 𝗾𝘂𝗮𝗻𝘁𝗶𝘁𝗮𝘁𝗶𝘃𝗲 (𝗲𝗺𝗽𝗶𝗿𝗶𝗰𝗮𝗹) 𝗿𝗶𝘀𝗸 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 was evident mid-year, taking up a significant portion of submissions. Time-consuming, but also statistically safe and the most data-disclosure-friendly. 🟩 The most sustained process has been the 𝗵𝘆𝗯𝗿𝗶𝗱 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵. Some quantitative assessment, some rules-based redaction. A balance of protecting privacy but still transparent. 𝙆𝙀𝙔 𝙏𝘼𝙆𝙀𝘼𝙒𝘼𝙔: This process is not binary. It's not either-or. It's dynamic, it's nuanced and it's complex. As regulations evolve, and the industry aligns, we are moving towards a process that optimizes safe, valuable and useful data publication. Building trust simultaneously through transparency and protection. ⚖ PS - Let me know if you're interested in some of the other results of this aggregate review! 📊📈 #ClinicalResearch hashtag #ClinicalDisclosure hashtag #BigPharma
