Emma Watanabe’s Post

Diversity in clinical trials - have you given any thoughts about your diversity plans? How exactly can you execute these plans? More importantly... where to even start? Fortrea offers a comprehensive and integrated "5-part process" solution for establishing, monitoring and reporting on Diversity Plan metrics in a clinical trials. Curious? Drop me a message! Or take a look at Joshua Richter's article - discusses the lack of diversity in clinical trials and how community oncologists can help overcome these disparities. #DiversityPlan #ClinicalTrials #oncology #diversity #Phase3

WATCH: Experts discuss several recent data updates in polycythemia vera and myelofibrosis in the context of the treatment landscape and its impact on clinical practice. #oncology https://lnkd.in/e3eHM6K7

Rethinking Clinical Trials in Oncology: Embracing Pragmatic Approaches Traditional randomized controlled trials (RCTs) in oncology often come with heavy monitoring, numerous assessments, and frequent follow-up visits. While essential for rigorous data, these demands can be overwhelming for participants, investigators, and sponsors alike. FDA believes that it's time to consider pragmatic clinical trials that mirror routine clinical practice more closely. These trials can streamline processes and focus on demonstrating efficacy with clear, straightforward endpoints like overall survival. For example, a critical question we should be asking is, "What is the median overall survival for patients with [specific type of cancer] treated with drug X versus drug Y?" By adopting pragmatic approaches, we can reduce the burden on all stakeholders while still obtaining valuable, real-world data. How is this possible? Let FDA know your two cents! It's its one-of-a-kind approach, #FDA wants you to share your ideas! This initiative allows the #innovators and key stakeholders in the field, to voice their opinion where it's heard the clearest! #Oncology #ClinicalTrials #HealthcareInnovation #PatientCentric #MedicalResearch Link to my two cents 👛: https://lnkd.in/ecgtkNJJ

Incredible results in a challenging study proves #Dermtech can accurately rule out melanoma greater than 99% of the time. Trust II is a follow up study on an already successful trial; which is rarely done. The reason being that the possibility of contradicting your initial positive results is a risk very few companies are willing to take. #Dermtech enrolled 8,000 more patients than Trust I to validate its claims as a first in class melanoma rule out test. The outcome provides concordance to TRUST 1 that the NPV for this test is still greater than 99%

There are some clinical issues that are incredibly difficult to address due to the lack of scientific evidence, yet have a major impact on our patients and their loved ones. One such issue is clinically assisted hydration (CAH) in the last days of our patients' lives. I hope that this article, which is deliberately aimed at real-world practice, will help you from now on. #MASCC #supportivecare #supponc

Due to the specific and objective nature of tumor response criteria, interrupting clinical trial results can be difficult. This Luminations video from the Cholangiocarcinoma Foundation breaks down the metrics used to evaluate a tumor's response to treatment to help patients understand their results. Watch the full video and share it with your networks: https://lnkd.in/eiD8rTd6

View the ‘Best Practice Exchange in Clinical Case Scenarios’ program to listen to experts in the field discussing the latest evidence supporting the use of new therapies in clinical practice. https://lnkd.in/davDGh5t

Patients are a Virtue! Thanks to John Emmerson (one of our CCC board members) from London Agency and Sara McLaughlin-Barrett from MedWise Consulting for hosting this insightful webinar on 'Clinical Trials and Tribulations'. Some key insights and quotes: "How is it that we are doing something to a patient and the patient isn't involved? We need to remember that clinical trials are about knowledge exchange and patients are the experts." Libby Noble Alexion Pharmaceuticals, Inc. "Patient organisations play an important role in helping to share information about clinical trials." Cathy Slattery Rare Cancers Australia "Sometimes patients perceive clinical trials as negative and that they are 'guinea pigs'. This could not be further from the truth." A/Prof Tom John Peter MacCallum Cancer Centre "Patients have so many questions like; where do I find out what clinical trials are available? Am I eligible? How much does it cost? Will I be on placebo? Will I have a multidisciplinary team? What is a clinical trial?" DAVID YOUNG The complete webinar is now live, and you can watch it here. https://lnkd.in/ganG6nYG Feel free to share this among your networks.

Tubulis GmbH has queued a first-in-human study of TUB-040, composed of an IgG1 antibody targeting Napi2b connected to its payload, the Topoisomerase I inhibitor Exatecan, through a cleavable linker system. The company’s P5 conjugation technology was used to build TUB-040 with a homogenous DAR of 8. Due to start in May 2024, the Phase 1 study aims are to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and non small cell lung cancer. Further information about the molecule can be found here: https://lnkd.in/eENKHHst https://lnkd.in/e79WwqZA