The drug development paradigm in oncology proceedings of a workshop
"Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline,...
| Autores Corporativos: | , , , |
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| Otros Autores: | |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Washington, District of Columbia :
The National Academies Press
2018.
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| Edición: | 1st ed |
| Materias: | |
| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622092306719 |
Tabla de Contenidos:
- Intro
- Title page
- Front matter
- Reviewers
- In Memoriam
- Acknowledgments
- Contents
- Boxes, Figures, and Tables
- Acronyms and Abbreviations
- Proceedings of a Workshop
- Background on Drug Development and Regulatory Review
- Type of FDA Drug Development and Approval Pathways
- Ethical Requirements of Clinical Research
- Exploring the Challenges with Traditional Clinical Development
- Inefficiences and Long Development Timelines
- Generalizability of Clinical Trial Results to Clinical Practice
- Appropriate Use of Biomarkers and Surrogate Endpoints
- Finding the Right Dose
- New Strategies in Oncology Drug Development
- Patient-Centered Drug Development
- Informed Consent
- Patient Risk
- Mechanism-Informed Cancer Drug Development
- Targeting Mutations in Breast Cancer
- Targeting the Microenvironment in Multiple Myeloma
- Fictional Imaging
- New Endpoints
- Modeling
- Process Modeling the Drug Development Pathway
- Dosage Modeling
- Modeling Benefits and Risks
- Development and Use of Biomarkers in Cancer Clinical Trials
- Innovative Clinical Trial Designs
- Adaptive Designs
- Seamless (Continuous) Clinical Trial Designs
- Master Protocols
- Clinical Trials with Common Control Arms
- Issues to Consider with Innovative Clinical Trial Designs
- Leveraging Real-World Evidence from Clinical Practice
- Pragmatic Trials
- Using EHR Data in Studies
- When to Use Real-World Evidence
- Standardization
- Guidance on Standardizing and Using Real-World Evidence
- Patient Privacy
- Expanding Clinical Trial Eligibility
- Collaboration
- Potential Policy Opportunities
- Innovations at CMS
- FDA Oncology Center of Excellence
- Expanded Access
- Cancer Moonshot
- Examples of Innovations in Cancer Drug Development
- Development of Crizotinib
- Development of Avelumab
- Development of Pembrolizumab.
- Development of Vamurafenib
- T790M EGFR Inhibitors
- Workshop Wrap-up
- References
- Appendix A Statement of Task
- Appendix B Workshop Agenda.
