FDA Collaborates on White Papers for Improving Innovative Drug Development
FDA’s Office of Clinical Pharmacology (OCP) + Duke-Robert J. Margolis, MD, Center for Health Policy expert working group
Improving Productivity in Pharmaceutical Research and Development: The Role of Clinical Pharmacology
Enhancing clinical pharmacology tools and methods for improving efficiency of development process and body of evidence
Utilization of Quantitative and Systems Pharmacology (QSP) and Model-Informed Drug Development (MIDD) potentially can:
- Lower the risk inherent in early-stage decision-making
- Positively address the late-stage attrition trends in development
- Ensure right investigational compound is hitting right target in right patient
Highlights key priority areas to advance biomarker development and precision medicine Challenges include:
- Lack of consistent and coherent set biomarker definitons and uses
- Confusion on regulatory pathways for biomarker acceptance
- Data standards
- Rigor in data practices
- Improved collaboration in data sharing between interested stakeholders.
- Lack of coordination and prioritization of limited public and private resources
Be A Champion for Clinical Trial Diversity
by: Dr. Jonca Bull, Assistant Commissioner for Minority Health, Office of Minority Health
FDA launching campaign to encourage minority participation in clinical trials
It supports FDA’s initiative: “The Year of Clinical Trial Diversity.”
- Need diverse pool of research participants—racial and ethnic minorities, women, even the elderly – to ensure safety for everyone
- Health disparities important — diseases that occur more frequently or appear differently in non-white populations
- Clinical trials participants need to more closely mirror the patients who will ultimately use the medicine
- Campaign includes educational aids such as videos, a blog, and an infographic
Watch and share videos and other educational aids (more in this blog)