FDA Views: Clinical Pharmacology White Papers, Clinical Trial Diversity – Drug and Device Digest

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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

Facilitating Biomarker Development: Strategies for Scientific Communication, Pathway Prioritization, Data-Sharing, and Stakeholder Collaboration

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

Jonca Bull, M.D., is Director of FDA’s 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)


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