Center for Outcomes Research
PRO or QOL Projects
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Meet John Mackowiak PhD
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John Mackowiak can select, develop, validate, publish and/or implement your Quality of Life projects.
 
Twice John Mackowiak has presented PRO (QOL) instruments which he validated to the FDA Oncology Drug Advicory Committee (ODAC) and both times they voted to agree the instrument was relaible and valid. 

FDA Votes

ODAC members voted 11 to 1 that the PBQ instrument validated and reported by John Mackowiak PhD did support the application for amifostime. PRO wording from that analysis still exists in the package insert today.
 
At a subsequent ODAC meeting reviewing a diffeent product the ODAC voted that the instrument validated by John Mackowiak was a valid measure of patient benefit able to measure significant important differences.

Quality of Life (PRO) Services

  • Strategic PRO intrument selection
  • Protocol development
  • Instrument development
  • Validation (internal and external)
  • QOL education
  • Publication
  • Use in registries and web sites
 

919-942-9903 phone - 919-619-3838 cell - jmackowiak@c-o-r.org