FDA Views: Parkinson’s Patient Voice, EvGen II FDA Voice – Drug and Device Digest

FDA BRIEF: Week of May 2, 2016



  • Part of FDA’s Patient-Focused Drug Development initiative
  • Obtain input from patients, caretakers,patient representatives on : (1) Effects of Parkinson’s disease that matter most to patients and (2) Patients’ perspectives on treatments for Parkinson’s disease.

Key Themes

  • Progressive, devastating disease: Difficulty of living with the unexpected onset and progression of symptoms – bradykinesia, dyskinesia, tremor, dystonia, sleep disturbances, cognitive impairment, fatigue, and constipation.
  • Impacts all aspects of patients’ lives: Severe limitations in performing at work, caring for self and family, and maintaining relationships and emotional toll
  • Complexity of disease management: Selection of options, timing, pill burden, adjustments to daily changes in symptoms
  • Using combination of drug and non-drug treatments. For optimal symptom management
  • Need for medications for delaying symptom onset or slowing symptom progression 



FDA Voice


EvGen Part II:

Building Out a National System for Evidence Generation


Rachel E. Sherman, M.D., M.P.H., Associate Deputy Commissioner

Robert M. Califf, M.D., Commissioner 


EvGen Part I posted previously in this  blog

Need to remove barriers to data sharing

  • Common approach for data presentation, reporting and analysis
  • Transparent rules of engagement across all stakeholders
  • Output public good and readily accessible to all stakeholders.

Vision for EvGen

  • Common attributes for drug/biologic/device reviews: Characterization of individuals and populations and associated clinical outcomes
  • Secondary use(s) of data in related fileds

Examples of Related Initiatives

  • Sentinel Initiative
  • National Patient-Centered Clinical Research Network (PCORnet)
  • NIH Health Care Systems Research Collaboratory
  • Reagan-Udall Foundation Innovation in Medical Evidence Development and Surveillance (IMEDS) Evaluation Program
  • National Device Evaluation System (NDES)

More in future postings





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