Worldwide Clinical Trials’ Post

Navigating Project Optimus in early oncology clinical trial design Experts james eamma, Executive Director, Therapeutic Strategy Lead, Oncology & Hematology at Worldwide Clinical Trials shared strategies for creating strong and cost-friendly outsourcing relationships that can propel clinical studies. - https://lnkd.in/dsiu4Yst #oncology #clinicaltrials #projectoptimus #clinicaltrialoutsourcing

Excited to share our recent article on optimizing decision-making in oncology trials! Making Go/no-go decisions in early oncology trials is fraught with sparse data, inconclusive metrics and confounding factors. How can we improve predictive accuracy- i.e., provide better metrics to help promote efficacious therapies while at the same time, reduce expensive failures? The answer might lie in taking a closer look at tumor dynamics and leveraging historic data, as explored in this in-silico analysis Special thanks to Brian Topp Aparna Mohan Thiagarajan Kannan Rukmini Kumar 😃 https://lnkd.in/g7zPKexA

Brilliant article written by my dazzling colleague Rebecca Goldstein, PhD, CMPP from #EnvisionPharma and published online today at Drug Target Review. Rebecca summarizes that the "oncology markets are now getting so hyper-segmented that the best drug value propositions are those that clearly anchor to real unmet needs from a specific patient group, not just a general tumor type". Let me know if you have questions or would like to set a time to talk to Rebecca and/or Envision the Patient. #Oncology #DrugDevelopment #Patient #MedComms #MedicalWriting

RELATIONSHIPS ARE KEY TO CLINICAL TRIAL SUCCESS The 13th Annual Clinical Trials in Oncology East Coast 2024 conference focused on building strong outsourcing, site, agency, and sponsor relationships as the key for smooth clinical trial operations. https://lnkd.in/e2nS2yiV #clinicaltrials #clinicaltrialpartners #partnership #collaboration #relationships #oncology #vendormanagement #outcomes #oncology #sponor #investigator #site #CRO #clinicalprojectmanagement

Developing an oncology treatment? A holistic, strategic plan from the start is key for success. Fortrea's blog explores considerations for clinical trials, real-world data, and navigating a global landscape. https://lnkd.in/eG8GkiPy #clinicaltrials #research #drugdevelopment

Year-end highlight for CHDR’s Oncology Group Approval received for proof-of-concept early oncology clinical trial: “Study to investigate the pharmacodynamic effects of single ascending dose of imatinib in healthy subjects using an adaptive Bayesian design (EU CT 0023-504958-35-00)”. CHDR is breaking new ground with an integrative oncology drug development program that aims to use the same biomarkers in both healthy volunteers and patients. By using an adaptive Bayesian study design and advanced trial biomarker methodology, the team focuses on early pharmacodynamic readouts instead of following a safety/tolerability-based dose escalation. This novel integrative approach has the potential to accelerate the drug development process in oncology and make early assessment of proof-of-pharmacology more efficient. Together with extensive biomarker exploration and the use of bone marrow analysis the study paves the way for safer and more effective dosing strategies in patient populations. Read more here: https://lnkd.in/eUuVjAxc #clinicalresearch #clinicaltrials #oncology

Check out this quick read on Innovations in Oncology Clinical Trials and learn more about how OPEN Health is supporting our clients in this area at #ASCO2024.

The landscape of oncology drug development is rapidly evolving, leading to a more pressing need for more efficient and effective approaches to clinical trial design and evaluation. This article explores how innovative trial designs and advanced imaging modalities can address the challenges of early drug development, ultimately optimizing outcomes for patients with solid tumors. Read more: https://bit.ly/4aTLxx2

The FDA Oncology Center of Excellence (OCE) Project 5 in 5 is a crowdsourcing initiative to ultimately identify 5 clinically relevant questions that can be answered through use of pragmatic clinical trials, using FDA-approved oncology therapies, over the next 5 years. https://lnkd.in/e2mun4uM

#ProjectOptimus From high dose chemotherapy to tailored, dose optimal, targeted therapy; cancer research has evolved with the sole purpose of providing patients with efficient tolerable treatments through the time since early stages of the research.