Syntheticus®’s Post

📣 Calling all Clinical Data Scientists and those working on Clinical Trials - JMP 18 has lots of updates for you. Check them out here 👇 #ClinicalTrialSafety #ClinicalTrials

OrphoMed Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics, today announced positive results from the recent Phase 2 study of ORP-101 for treatment of irritable bowel syndrome with diarrhea (IBS-D). The double-blind, placebo-controlled, 12-week response adaptive randomization study investigated once-daily doses of 100 mg and 50 mg of ORP-101 vs. placebo. The 100 mg dose was more effective than placebo, whereas the 50 mg dose did not achieve statistical separation. Overall, ORP-101 was safe and well tolerated in all patients. Importantly, ORP-101 was also effective and safe in post-cholecystectomy IBS-D patients at the 100 mg dose throughout the treatment period. https://lnkd.in/dagFrEjm

Trying to 'de-risk' a project by over-testing and collecting loads of data early on is tempting. But consider this: up to 40% of that data may never be used in your new drug application. Can you truly afford the extra time, cost, and burden it puts on sites, sponsors, and participants? If you want to minimize study complexity (and reduce trial costs), then check out our blog for some more effective tactics: https://hubs.li/Q02mYGGF0 #clinicaltrials #clinicalresearch

🚨 The world of clinical research is undergoing a dynamic transformation. Although clinical trials have long been the gold standard for evaluating new pharmaceutical treatments, the inclusion of Real-World Data (RWD) and Real-World Evidence (RWE) is revolutionizing all stages of clinical trial planning and execution, including: 👉 Enhancing patient recruitment 👉 Improving trial design 👉 Advancing personalized medicine 👉 Improving patient outcomes Learn how to leverage RWD and shape the future of clinical trials: https://bit.ly/41fcwSF

Bridging the gap between clinical trials and real-world patient experiences is crucial for advancing healthcare. Explore the evolving role of real-world evidence in drug development with insights from Rebecca Miksad, MD, MMS, MPH.

📰 Today in PharmaTimes Media Ltd, our Founder and President Gen Li, PhD, MBA discusses the new age of #ClinicalTrials. With nearly a third of phase II trials terminated in 2023, Gen highlights that sponsors must adopt a data-driven approach to improve success rates. 📈 Gen explains how Digital Patient Profiles and Digital Trial Arms help to reduce operational costs, improve patient-centricity, and get life-saving therapies to those who need them faster. 💊 👀 Check out the full article, here. https://lnkd.in/ebPG2P77

To wrap up their three-part series, Kym Denny Eves and Liam Eves discuss how various drug candidates come inherent with barriers to adoption that directly impact how participants and providers engage with clinical research. They also offer ways to clear these hurdles for faster, less costly trials. #clinicaltrials #clinicalresearch

The FDA guidance on diversity action plans is reshaping the landscape of clinical trials. Kevin Barber, Genna L. Andrews Kingon, PhD, RAC, and Michael Pace, Ph.D. break it down in their latest blog, providing practical insights into compliance and execution. As diversity remains a critical factor for the success of trials, this guidance offers a framework for sponsors to design trials that better represent all populations. Read on to see how you can align with these important regulatory shifts. https://bit.ly/3Zhfh4D

In the world of clinical R&D, the path to innovation is paved with data. Yet, navigating the labyrinth of clinical trial data, with its diverse formats and origins, presents a challenge for biopharma teams. Unifying clinical trial data is not just a technical endeavor, but a strategic imperative essential for clinical research. #datascience #clinicaltrials https://lnkd.in/gPhz3qq3

Want to learn about how efficacy data makes its way from clinical trials to the final package insert? Learn more about the journey in our latest blog. Read here: https://lnkd.in/gYZBvAXv