Boston app maker PHT has released its FDA Roadmap to Patient-Focused Outcome Measurement in Clinical Trials Android app. The app is designed to help sponsors of clinical trials consider, choose and develop a patient-focused outcome measurement strategy, the company said Tuesday.
PHT’s app follows the three categories of the FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials: “Understanding the Disease or Condition,” “Conceptualizing Treatment Benefit” and “Selecting/Developing the Outcome Measure.”
Within these categories are several levels of subcategories, in which sponsors can log patient- and caregiver-reported observations, observer-reported outcomes, severity and onset of disease and treatment alternatives and benefits. They can also select clinical outcome assessment and concept of interest options.
The app is available through PHT’s website or in the Google Play app store. An Apple version is coming soon, PHT said.
View the FDA roadmap at www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Drug
DevelopmentToolsQualificationProgram/UCM370174.pdf. — Lena Freund
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