Patient-Focused Drug Development: 
Rules of Engagement 

Incorporating the patient’s voice into clinical trial technologies development to enhance participants’ experiences and achieve trial outcomes

Facilitating protocol compliance with compelling user interface (UI) and patient engagement features 
Minimizing patient burden with elegant software design 
Adhering to industry best practice recommendations


  1. U.S. Food and Drug Administration. CDER Patient-Focused Drug Development.  (Accessed Jan 05, 2024.)
  2. Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W. Capturing patient-reported outcome (PRO) data electronically: the past, present, and promise of ePRO measurement in clinical trials. Patient, 2015;8(4):301-309.
  3. U.S. Food and Drug Administration. Guidance for industry—Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. (Accessed Jan 05, 2024.)
  4. U.S. Food and Drug Administration. Guidance for industry: electronic source data in clinical investigations. September 2013. (Accessed Jan 05, 2024.)
  5. Mowlem FD, Elash CA, Dumais KM, Haenel E, O’Donohoe P, Olt J, Kalpadakis-Smith AV, James B, Balestrieri G, Becker K, Newara MC, Kern S, on behalf of the Electronic Clinical Outcome Assessment (eCOA) Consortium, Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures, Value in Health (2023), doi:
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