Innovation in Combo Product Clinical Development – Harnessing Patient Insights from Reported Usability Outcomes

STUDY OVERVIEW

Whether you’re incorporating human factors into your clinical trials or engaging in dedicated human factors trials, collecting patient feedback helps solve myriad self-administration problems and ensures your products improve as many lives as possible.

The future of patient feedback is moving towards incorporating human factors feedback - such as injection-site pain, self-reported full dose delivery, and product technical failures - into major clinical trials rather than performing them separately. Learn how other organizations are successfully collecting patient feedback during major clinical trials and leveraging this data to ensure that patients stay adherent and face minimal obstacles while receiving treatment.

Best Practices, LLC conducted this research to help clinical leaders understand how companies are integrating patient feedback into their clinical data .

KEY TOPICS

• Executive Summary: Universe of Learning, Combination Product Types Represented, Key Segments, Key Findings
• Operational Insights: Teams Deployed, Sub-teams by Activity, Usability Outcomes Users, SOPs
• Trial Structure, Site, and Usability Outcome Measure Analysis
• Observer Vs. Patient Usability Reported Outcomes
• Observer Usability Reported Outcomes Analysis: Implementation Across Phases, Effectiveness
• Patient Usability Reported Outcomes Analysis: Implementation, Effectiveness, Case Analysis

• For combination products, how do other functions at your organization interact with clinical development for combo product development?
• What role does each of the following seven functions have as it relates to patient feedback data from clinical trials?
• How frequently are members of the formal team for clinical development scheduled to meet?
• Do you have documented business process or template questionnaire for patient feedback data collection in late stage clinical trials for combo products??
• What areas are addressed in your SOPs for late stage clinical studies?
• In what type of clinical trial were your company's to-be-marketed product first tested?
• For these trial milestones was the combo product administration done through home use, in-clinical administration or a mix of both?
• For combo products, has your organization incorporated patient, investigator, or observer based device usability feedback into any of these trial types?
• For these listed trial types, were usability measures collected from patients, primary investigators/ site staff or both?
• For the observer based usability feedback collected, which types of observer based measures were data collected for?
• For the patient usability feedback collected, which types of patient usability measures were data collected for?
  

• Development Team Composition: 100% of large companies implement a formal team for Combo Product clinical development. Team composition trends towards two forms – (1) Device oriented teams, and (2) Cross functional teams. Cross functional teams saw greater effectiveness in using reported usability outcome measures from clinical trials to improve products.
  
• Essential Roles: Key roles represented on cross functional teams include: (1) HEOR representative, (2) Marketing Representative, (3) Product Representative.

Best Practices, LLC engaged 11 industry leaders from 8 companies through a benchmarking survey.

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Health Care; Biotech; Clinical Research; Laboratories; Medical Device


Companies Profiled:
Novartis; Windtree Therapeutics; EMD Serono; Merck; Sanofi; Shire; Bausch + Lomb; Alkermes

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