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Products & Services Clinical Operations Clinical Roles and Trends

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

ID: POP-308


10 Info Graphics

19 Data Graphics

180+ Metrics

1 Narratives

Pages: 40

Published: 2019

Delivery Format: Shipped


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As the healthcare industry gravitates toward increased patient centricity in an all-out effort to achieve the best possible health outcomes, it follows that drug manufacturers are seeking new ways to successfully incorporate patient feedback into clinical development.

When it comes to combination product clinical development in particular, a host of factors allow healthcare companies to effectively harness patient insights from reported usability outcomes – right from the roles and structures of the development team itself to the deployment of new product innovations that drive enhanced usability for the patient.

Best Practices, LLC conducted benchmarking research to explore how leading companies are successfully collecting patient feedback during major clinical trials and leveraging this data to make it easier to ensure that patients stay adherent and face fewer obstacles during treatment.

This report delivers critical benchmarks around clinical development team structure, roles, and operational standards for driving enhanced usability. This report also highlights the optimal measure targets, utilization, and deployment of patient and observer usability measures being used by leading pharma, biotech and medical device combination product makers. This report also features a case study on the implementation of a wide-breadth patient-reported usability outcome program by a large leading biopharma company.

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

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

Study Snapshot

Best Practices, LLC engaged 11 industry leaders from 8 companies through a benchmarking survey.
Included in this research are qualitative insights and case studies generated from partnering with these industry leaders.

Key topics covered in this report include:

  • Combination product clinical development team structures
  • Effective sub-teams for critical development activities
  • Reported usability outcome measure data ownership and use
  • Late phase trial methods: Home-use vs. In-clinic vs. mix of both, timing of to-be-marketed device use
  • Observer & Patient reported usability outcomes by phase, effectiveness, and volume of implementation
  • The most effective and essential observer and patient outcome measures

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Late Phase Trial Analysis for Combination Products:
    • When first testing the to-be-marketed form of a combination product, structure trials with at least some component of in-clinic administration.
    • In-clinic administration is an essential trial design component when deploying usability outcome measures prior to Phase III, using a mix of home & in-clinic is more prominent for Phase III and Open label extensions.
  • 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.

Table of Contents

Executive Summary: Universe of Learning, Combination Product Types Represented, Key Segments, Key Findingspgs. 3 – 11
Operational Insights: Teams Deployed, Sub-teams by Activity, Usability Outcomes Users, SOPspgs. 12 – 18
Trial Structure, Site, and Usability Outcome Measure Analysispgs. 19 – 24
Observer Vs. Patient Usability Reported Outcomespgs. 25 – 27
Observer Usability Reported Outcomes Analysis: Implementation Across Phases, Effectivenesspgs. 28 – 35
Patient Usability Reported Outcomes Analysis: Implementation, Effectiveness, Case Analysispgs. 36 – 39

    List of Charts & Exhibits

    I. Operational Insights

    • Interaction of Clinical Development function with other functions for combination product development
    • Role of formal cross functional teams and key contributors / supporters
    • Leading and supporting role of cross functional teams during late stage trial design & protocol development, late stage outcome measure decisions, and late stage trial execution
    • Roles of functions that are responsible or interact with patient feedback data
    • Frequency and mix of standing and functional meetings for communication with internal stakeholders
    • Utilization of SOPs for patient feedback data collection in late stage clinical trials for combination products and areas addressed in the SOPs

    II. Trial Analysis

    • Type of clinical trial for first testing of to-be-marketed products, and administration site for first testing
    • Mode of combination product administration for the selected clinical trial(s) - home use, in-clinic administration, or a mix of both
    • Benefits and detriments of home and in-clinic administration; deployment of mixed administration site trials; and average interval for in-clinic visit
    • Frequency of use of combination product administration sites among all trial types - home use, in-clinic administration, and a mix of both
    • Incorporation of patient, investigator, or observer (i.e. site staff) based device usability feedback in late stage trials

    III. Patient vs. Observer Reported Usability Outcomes

    • Collection of usability measures from patients, and primary investigators/ site staff for combination product – total benchmark class
    • Collection of usability measures from patients, and primary investigators/ site staff for combination product - injection and auto injector segment

    IV. Observer Reported Usability Outcomes

    • Types of observer based measures for which data is collected - cumulative use across phases
    • Frequency of observer based measures used – total benchmark class
    • Frequency of observer based measures used – injection segment
    • Frequency of observer based measures used – auto injector segment
    • Effectiveness of observer-based measures in characterizing device usability performance – total benchmark class
    • Effectiveness score of observer-based usability measures - total benchmark class and injection segment
    • Effectiveness of observer-based measures in characterizing device usability performance – injection segment

    V. Patient Reported Usability Outcomes

    • Types of patient usability measures for which data is collected – total benchmark class; phases for patient usability measure implementation
    • Case study for large scale implementation – company’s formal team, observer usability and patient usability in phase II and phase III
    • Case study for large scale implementation - patient usability measures effectiveness