X4 Pharmaceuticals’ Post

Neglecting patient-centric trial design can cost clinical trial sponsors time and money when attempting to conduct research. Learn more about how to start off the trial process to be more inclusive in our latest blog: https://hubs.ly/Q02h1XBq0

Looking for investigators to enroll patients for your study? Look no further! Citeline Clinical got you covered. Worried about fulfilling the #FDORA requirements on #diversity in #clinical trials? Are you not sure what the soon to become available updated FDA guidance on developing a plan to improve enrolment of underrepresented #patient populations? Want to learn more? Feel free to reach out to me directly!

In this commentary, the authors highlight possible issues and solutions to be considered with placebo-controlled designs and primary endpoints as proposed in the recent clinical trial design guidelines for cluster headache: https://lnkd.in/dKkT7H6K

Listen to several SPHERE Per-AF IDE Clinical Trial Investigators review the safety outcomes of the first ever randomized trial to use PFA. Learn more here: https://bit.ly/4aYcjo7

he Quest Begins: Phases of a Clinical Trial Think of a clinical trial as a journey divided into phases: Phase 1: This is the "getting to know you" phase. Researchers test the new treatment on a small group of people to check for safety and dosage. Phase 2: Time to expand the horizons! Now, the treatment is given to a larger group to see if it's effective and to further evaluate its safety. Phase 3: The big leagues! Here, researchers compare the new treatment with existing ones to determine its effectiveness, safety, and side effects. This phase involves a much larger group of participants. Phase 4: Think of this as the after-party. Once a treatment is out in the world, researchers continue to monitor its long-term effects and gather more information.

In order to prioritize patients in #clinicaltrials, a CRO #centrallab should provide tools and systems that oversee all trial aspects, sharing real-time data with project teams for informed decisions, especially in complex trials. Hear from experts Chris Clendening, Olivia Aspite, Tricia Moloy (Abbott) and Tracy Roe in this webinar to learn how we are changing the central lab paradigm to make studies more efficient. » https://bit.ly/48YPErV

In the RedDrop One clinical trial, 100 subjects underwent testing to achieve a minimum volume of 150μL. Remarkably, only 3 subjects fell short of this threshold, resulting in an impressive 97% success rate. What's more, the speed at which these volumes were obtained is noteworthy. As depicted in the graph below, a vast majority of subjects yielded over 400μL of whole blood in under 5 minutes, with an average exceeding 550μL. In a realm where sample volumes are highly valued, RedDrop's collection efficiency truly shines.

To prioritize patients in #clinicaltrials, a CRO #centrallab should provide tools and systems that oversee all trial aspects, sharing real-time data with project teams for informed decisions, especially in complex trials. In this recent webinar, our experts Chris Clendening, Olivia Aspite, Tricia Moloy (Abbott) and Tracy Roe explain how PPD® Laboratory services are changing the central lab paradigm to make studies more efficient. » https://bit.ly/48YPErV