Webinar: How DMCs Assess Risk-Benefit with Data Summaries

🖋️✨ DUMMY TRIALS ✨🖋️ 🗂️ #16: Case Report Forms (CRFs): The trial’s diary pages Every patient visit is written down in CRFs. 📔 Who got what 📔 How they felt 📔 What changed Without CRFs, data just floats in memory. With CRFs, science has a paper trail. #DummyTrials #ClinicalTrials #ClinicalResearch #ScienceForBeginners #Research101 #TheOttawaHospital #CaseReportForms

End of Trial vs. Last Patient Last Visit .. not the same thing. Many people think the end of trial happens the moment the last patient completes their last visit. It sounds logical, but it’s not the full story. Last Patient Last Visit (LPLV) marks the end of data collection. But the End of Trial (EoT) goes beyond that, it’s when all data are cleaned, queries resolved, databases locked, and final analyses ready. In other words: LPLV closes patient participation. EoT closes the study’s lifecycle. Understanding this difference is crucial, because regulatory reporting timelines often start counting from End of Trial, not LPLV. #ClinicalResearch #ClinicalTrials #ClinicalOperations

In his latest op‑ed for MedPage Today, ACOG President Steven Fleischman, MD, MBA, FACOG, addresses how fear can overshadow data and calls on the medical community to counter misleading warnings and guide patients with compassion, clarity, and evidence. Read his full piece: bit.ly/434bE3m

Pregnant women deserve accurate, evidence-driven guidance - not more confusion. Regulatory language should protect, not alarm. American College of Obstetricians and Gynecologists (ACOG) ’s response is a reminder of how critical clear risk communication is in maternal health. Thank you to Steven Fleischman, MD, MBA for the thorough explanation of the topic, and deep validation of women's worries, highlighting the unnecessary guilt this brings to the families who are already dealing with the problems discussed.

tCBT new paper: Practice of therapeutic skills with memory versus video-based self-reflection: a mixed-method randomized controlled trial Full free text at https://lnkd.in/eCWWx3A9

𝐒𝐭𝐫𝐨𝐧𝐠𝐞𝐫 𝐃𝐚𝐭𝐚. 𝐒𝐭𝐫𝐨𝐧𝐠𝐞𝐫 𝐓𝐫𝐢𝐚𝐥𝐬! In clinical research, success depends on the quality and integrity of your data — from the very first collection to final submission. Discover how the right #DataManagement partner and early alignment can transform your trial outcomes 👇 Get Your Full Guide here: https://lnkd.in/eT9J_r_C

While the use of preference data from discrete choice experiments in cost-benefit analysis (CBA) has been proposed in the literature since the 1990s actual applications are rare and workable frameworks limited. Here is one example of a CBA using Hicksian consumer surplus that we explored in an application concerned with exome sequencing. To the best of our knowledge this is also one of very few CBAs in health that account for preference heterogeneity. We use our setup to derive preference-based cost-acceptability curves. There are many other ways to do a CBA (e.g., by integrating preferences into a CEA model). https://lnkd.in/e-HNM8Xu Thanks to my co-authors: Deborah A Marshall , Karen MacDonald , Nicolas KRUCIEN , and others Needless to say: Not suitable for submission to an HTA agency!

Why should clinical trial data be shared with others for re-use and how do secondary data researchers go about finding and accessing these data? Georgina will discuss the current landscape of clinical trial data sharing from her experience first as data user herself, then as a funder, and most recently as an advocate and enabler of ecosystem.

We've updated our Frequently Asked Questions about Core Trust Seal accreditation! In 2019 MEDIN Data Archive Centres (DACs) endorsed a move to adoption of Core Trust Seal (CTS) accreditation in place of MEDIN accreditation, recognising the organisational and reputational benefits such accreditation will give them. https://hubs.la/Q03P7kh70 Find out more about our Data Archive Centres https://hubs.la/Q03P7krn0 and read about Core Trust Seal: https://hubs.la/Q03P7mgj0

Real World Data and Insights from LexisNexis® Risk Solutions helps capture a more complete picture of patients to confidentially define cohorts and gain more representative, actionable insights that accelerate clinical research. Watch the video at https://splr.io/6047tGBKl