Raptim Research Pvt. Ltd.’s Post

Oncology clinical trials are evolving with innovative strategies to improve success rates. Learn how continuous reassessment of critical factors, strategic patient selection and effective program prioritisation can optimise your oncology trials. Dive into our latest blog for insights: https://ow.ly/rSMA50SZaTW

When considering Trial Design, it's essential we consider the impact (burden) to the patient. The addition of Home Healthcare to your study design reduces this patient burden and significantly increases the overall patient experience. Crucially, it also offers demonstrable benefits and improvements to Patient Recruitment (including engagement with underserved communities) & Retention. Contact me directly (phil.woodhead@iconplc.com) to begin exploring this strategy and how it can directly benefit your study.

Join WI's Britta Jacobsen, PhD, for a fascinating session on the FDA's Oncology Center of Excellence Real-Time Oncology Review (RTOR) with experts from industry and the FDA. Need insights into process, best practices, and how RTOR can impact global submission planning? This session is for you. #DIA2024 #WeSpeakScience #medicalwriting

Join WI's Britta Jacobsen, PhD, for a fascinating session on the FDA's Oncology Center of Excellence Real-Time Oncology Review (RTOR) with experts from industry and the FDA. Need insights into process, best practices, and how RTOR can impact global submission planning? This session is for you. #DIA2024 #WeSpeakScience #medicalwriting

Australia, with its robust healthcare infrastructure and access to diverse patient populations, can play a pivotal role in accelerating clinical trials. Our upcoming webinar will delve into a real world case study, showcasing how Australia’s data can be leveraged effectively. We’ll explore a clinical development plan that tackles the unique challenges encountered by sponsors during oncology drug development. Join us on 21 May to gain valuable insights and learn strategies for overcoming obstacles in early phase oncology studies. https://bit.ly/3V7dzjY #ClinicalDevelopment #EarlyPhaseOncology #Webinar

When considering Clinical Research Organizations (CROs) for oncology trials, what's the top priority for you? 💡 Oncology Expertise and Experience 💡 Access to Cutting-edge Technology and Treatments 💻 💡 Patient-Centric Approach and Support 💡 Quality of life 💡 Comprehensive Regulatory Knowledge and Compliance 📜 Comment the factor that holds the most significance in your oncology research endeavors and share your insights! #OncologyResearch #CROPriorities

Are cancer treatment pathways really making a difference in clinical and economic outcomes? Check out our recent article in Journal of Clinical Pathways to see what our latest research suggests. #clinicalpathways #MAIPathwaysReport #HMPMarketAccessInsights

Stay tuned ⭐️⭐️⭐️ For oncology pharmacists We are thrilled to launch a new series of discussions on Oncology Pharmacy Best Practices, featuring the QUAPOS Handbook in collaboration with ESOP Global! 🌟 This series aims to provide invaluable insights and expert guidance to enhance oncology pharmacy practices worldwide. #OncologyPharmacy #BestPractices #QUAPOS #ESOPGlobal #PharmacyExcellence #HealthcareInnovation

In my view, the authors raise a sensitive issue but come to a dangerous conclusion.   AA is granted due to an unmet medical need - for drugs that have the potential to satisfy this unmet need. For proving this, confirmatory trials are imperative. However, how do you handle the situation, when those trials fail to confirm?   The authors propose to decide in a view of other available therapies, as it may happen that "the available therapies have not changed and an unmet medical need still exists". This ignores the fact that with the results of the confirmative trial one important factor has changed - trial results now argue against the assumption of benefit.   The authors further argue that the "inability to verify clinical benefit may be due to issues with confirmatory trial methodology, dosage selection, and population". This is true, but also something that needs to be addressed in the planning of the confirmatory trial. As such, I see the need to address this within scientific advice. We must not squander patient and doctors for insufficiently planned clinical trials!   In a way, the authors argue for a repetition and prolongation of AA. I wonder whether this is really feasible. They propose the FDA should "allow the sponsor to pursue alternative confirmatory trials, provided such trials are feasible and can be conducted in a timely manner". However, there is a reason that FDA "may now require that confirmatory trials be underway before granting AA": We are very aware of the fact that confirmatory trials face severe challanges in patient recruitment and conduct, if the drug is already commercially available.   Thus, the proposal leads in the exact pitfalls that were thought to be avoided with coupling AA to confirmation. In addition, health systems already today struggle with deciding upon the use of drugs with sparse data and ever higher prices - the situation will not become any better by this. What do you think?:   Harald Enzmann Tom Mayer Anja Schiel Maximilian Blindzellner Anna B. Robert Sauermann Michael Berntgen Marc Van de Casteele