Results for 'observational study'
E Dawn Flick, Howard R Terebelo, Susan Fish, Amani Kitali, Vrinda Mahajan, Melissa Nifenecker, Kristen Sullivan, Paul Thaler, Sarah Ussery, David L Grinblatt
The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
registry, oncology, observational study, prospective cohort study, real-world evidence
Oncology patient registries are valuable for generating Real-World Evidence (RWE) due to: Prospective, primary data collection Characterizing smaller patient populations not typically included in clinical trials Providing insights into the rapidly changing disease course Allowing for longitudi…
Jun 7th • 8 mins read
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
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
clinical guidelines, FDA, accelerated approval cancer drugs, surrogate measures, NCCN, EMA
Six of 18 cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines despite no improvement in the primary endpoint in post-approval trials. These findings reflect the lack of fulfillment of the compromise between…
Aug 4th • 12 mins read
Adela Rodriguez, Francis Esposito, Helena Oliveres, Ferran Torres and Joan Maurel
Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?
quality randomized studies, ESMO-MCBS, drug approval
The approval of new cancer drugs by the FDA and EMA is primarily based on positive results from well-designed randomized phase III clinical trials (RCTs). Not all RCTs are analyzed to support drug approval recommendations, highlighting the need for scales to evaluate RCT quality and clinical…
Feb 11th • 3 mins read
Muneera Al Hussain
Comment on: Oncology research in Saudi Arabia over a 10-year period. A synopsis
oncology research, saudi arabia
An article in the Saudi Medical Journal by Alghamdi et al reported on oncology research progress in Saudi Arabia. The study compared research quantity and quality between two periods: 2008-2012 and 2013-2017. There was an increase in the amount of research over time, but quality and scienti…
Jun 24th • 3 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Oncology, Clinical Development, Targeted Therapy, Immunotherapy, Genomic Profiling, CAR-T Cell Therapy, Precision Medicine
Real-world evidence (RWE) complements traditional randomized controlled trials by providing insights from diverse data sources, helping healthcare decision-makers with coverage, reimbursement, and treatment guidelines. Artificial intelligence (AI) and natural language processing (NLP) are pivotal…
Aug 22nd • 5 mins read