Highlights
- •Usage of real-world data (RWD) for clinical implementation is gaining popularity.
- •Use of SCRUM-Japan Registry for the phase II TRIUMPH study was investigated
- •We've paved way for RWD approval in Japan
- •Future steps for building regulatory-grade registries and using RWD must be defined
Abstract
Keywords
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical Colorectal CancerReferences
Statement from FDA Commissioner Scott Gottlieb MD, on FDA's new strategic framework to advance use of real-world evidence to support development of drugs and biologics. Available at: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fdas-new-strategic-framework-advance-use-real-world. Access date is 25th July, 2022.
- When and how can real world data analyses substitute for randomized controlled trials?.Clin Pharmacol Ther. 2017; 102: 924-933
- The new fda real-world evidence program to support development of drugs and biologics.J Diabetes Sci Technol. 2020; 14: 345-349
- Barriers and opportunities for use of patient registries in medicines regulation.Clin Pharmacol Ther. 2019; 106: 39-42
Available at: https://www.ema.europa.eu/en/guideline-registry-based-studies. Access date is 25th July, 2022.
- Editorial: registries and population databases in clinical research and practice.Med Sci Monit. 2021; 27e933554
- Regulatory science to 2025: an analysis of stakeholder responses to the european medicines agency's strategy.Front Med. 2020; 7: 508
https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu. Access date is 25th July, 2022.
Basic principles on Utilization of Registry for Applications https://www.pmda.go.jp/files/000240810.pdf. Access date is 3 August, 2022.
Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications https://www.pmda.go.jp/files/000240807.pdf. Access date is 3 August, 2022.
- Guidelines for clinical evaluation of anti-cancer drugs.Cancer Sci. 2021; 112: 2563-2577
- Comparing GOZILA and COLOMATE: ongoing umbrella/basket trials examining genetic testing in gastrointestinal malignancies.Oncology (Williston Park). 2021; 35: 382-389
- SCRUM-Japan GI-SCREEN and MONSTAR-SCREEN: path to the realization of biomarker-guided precision oncology in advanced solid tumors.Cancer sci. 2021; 112: 4425-4432
- Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial.Nat Med. 2021; 27: 1899-1903
- Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from mypathway, an open-label, phase iia multiple basket study.J Clin Oncol. 2018; 36: 536-542
- Pertuzumab plus trastuzumab for treatment-refractory HER2-amplified metastatic colorectal cancer: comparison of the mypathway trial with a real-world external control arm.JCO Clin Cancer Inform. 2022; 6e2200022