Results for 'metastatic breast cancer'
Min Jeong Kim, Hyo Jung Kim, Danbee Kang, Hee Kyung Ahn, Soo-Yong Shin, Juhee Cho, Yeon Hee Park,
Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study
real-world data, preliminary attainability assessment, observational study, clinical data warehouse, PAR framework, brain metastasis, breast cancer
The study proposes the PAR framework for data attainability screening in clinical research, particularly useful for addressing unmet clinical needs in BCBM. A survey showed clinical questions had a mean score of 4.37, indicating the significance of these questions. RWE generation is crucial…
Oct 9th • 4 mins read
Emerson Y. Chen, MD, Sunil K. Joshi, BA, Audrey Tran, BA
Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials
bevacizumab, metastatic breast cancer, RR, PFS, FDA, oncology clinical trials
The use of Response Rate (RR), Progression-Free Survival (PFS), and Overall Survival (OS) in clinical trials leading to FDA approval is associated with different study durations: RR: Median study duration of 25 months (range, 11-54 months). PFS: Median study duration of 31 months (range, 10-…
Apr 1st • 10 mins read
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
biomarker, clinical trial, failure, analysis, NSCLC, oncology
Data from clinical trials across four oncology indications (breast cancer, NSCLC, melanoma, and colorectal cancer) from 1998 to 2017 were analyzed to assess drug approval likelihood based on biomarker status. Using multi-state Markov models, which describe stochastic processes, the study…
Feb 23rd • 8 mins read
Thakur, Sayanta & Lahiry, Sandeep
Accelerated drug approvals in oncology: Pros and cons
Clinical study, drug approval, medical oncology
The summary of the content highlights the success of the accelerated approval process, especially for oncology drugs. Key points include: The rise of accelerated approval processes is significant, particularly in oncology. The use of surrogate endpoints and their validation has been debated. Th…
Sep 14th • 4 mins read