DIA’s Post

This is a well-timed article. Ultimately, clinical trials and independent validation should determine the verdict on these tools. That should include peer-reviewed publications and public analyses of pipeline development timelines. https://lnkd.in/et_mnp3p

Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence   📅 DATE: April 25, 2024 | 9:00 AM - 1:00 PM ET ▶ LOCATION: Zoom   The FDA's new Center for Drug Evaluation and Research (#CDER) Quantitative Medicine Center of Excellence (CoE) is hosting a virtual #workshop to introduce the #CDER QM CoE, providing an overview of the scope, goals, and current state.   #QuantitativeMedicine (QM) uses exposure-based, #biological, and quantitative #models from various data sources to enhance #drugdevelopment #regulatory decisions, and #patientcare.    Workshop objectives: 📌 Provide an overview of the newly formed #QM CoE, including discussion of the current goals, initiatives, and priority areas 📌 Engage with stakeholders to inform future QM CoE initiatives in education, outreach, and #policy development   ✍ Register here: https://lnkd.in/g4YWZEDg

Clinical research and therapeutic development are moving forward at a lighting fast pace. Among the many advancements, randomization and trial supply management (RTSM) stands out as a critical innovation, fundamentally reshaping how clinical trials are designed, executed, and managed globally. 👀 Read how Oracle is pioneering global RTSM solutions in the latest article by Wissam Kazan, VP of Product and Engineering for Clinical Research. https://lnkd.in/e8xjBPrw #clinicalresearch #clinicaltrials #lifesciences #drugdevelopment

ArabMed-CRO: Advancing Clinical Research, Amplifying Impact. (Formerly Mesned-CRO) Follow our Page for the latest updates

You may have seen news about the FDA's new initiative, the Quantitative Medicine Center of Excellence from the Center for Drug Evaluation and Research [CDER]. In line with this, the FDA is hosting a free workshop on Apr 25th from 9 am to noon, US East Coast time. Here is a link to the workshop and to the free registration: https://lnkd.in/gP83xVde The workshop has a two-fold objective: [1] To provide an overview of the newly formed Quantitative Medicine [QM] Center of Excellence [CoE], including a discussion of current goals, initiatives, and priority areas and [2] To engage with stakeholders to inform future QM CoE initiatives in education, outreach, and policy development. The meeting materials can be found here: https://lnkd.in/gUjZXXCy

The proposed process guide for evaluating causal effects of drugs using healthcare data includes five key steps: Formulate a causal question via specification of the target trial protocol Emulate each component of the target trial protocol and identify fit-for-purpose data source Assess expected precision and conduct diagnostic evaluations Develop a plan for robustness assessments including deterministic sensitivity analyses, quantitative bias analyses, and net bias evaluation Conduct inferential analyses The authors address potential challenges and biases in inferential studies using routine clinical practice data by providing practical guidance on critical aspects of the process of evidence generation, including determining fitness-for-purpose of the data source, registering study protocols, considering principled adaptations over the course of a study, and planning robustness evaluations. They also emphasize the importance of transparent communication between various stakeholders and the need for critical considerations in the clinical research community. #healthcaredata

Still not too late to attend 2024 CERSI UCSF-Stanford symposium at Stanford today. In addition to driving innovations in science and technology, let’s not to forget to advocate, support and participate in regulatory innovation, which is equally important for bringing more effective medicines faster to treat formidable diseases such as #cancer #metastasis

Stuart McCully (RWR-Regs) delves into the nuances of the newly-announced FDA and National Institutes of Health draft glossary aimed at establishing consistency in clinical and #RWE research terminology. Read the latest Column at The Evidence Base® #rwd #realworldevidence #realworlddata #pharma #biopharma #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

ArabMed-CRO: Advancing Clinical Research, Amplifying Impact. (Formerly Mesned-CRO) https://lnkd.in/e4zwswSg

Interestingly, the terms ‘real-world data (RWD)’ and ‘real-world evidence (RWE)’ are not included in the glossary....