cases-studies-icta

Prevention & Treatment of a non-serious dermatological condition on the foot

OBJECTIVES

PRIMARY OBJECTIVES

  • Preventive study: Prevention
  • Curative study: Instant pain relief

    SECONDARY OBJECTIVES

    • Preventive study
      • Plaster adhesion & rubbing off
      • Duration of use
      • Usability (only for hydrocolloid plasters)
      • Global perception/satisfaction
      • Safety (only for hydrocolloid plasters)
    • Curative study
      • Pain relief evolution
      • Pressure relief
      • Duration
      • Time to Healing

    SCIENTIFIC and DATA vALORISATION

    • 2 Clinical Study Reports (ISO14155:2020 template)
    • 2 Clinical Study Reports (ISO14155:2020 template)
    • 4 Clinical Evaluation Reports (CER) updates performed by another provider (CER are key reports to update each product CE marking dossier)
    • 2 Scientific publications ongoing Q1 2023
    • 1 Scientific communication on November 2022 atDMB congress : on the rescue decentralized digital plan, the associated CNIL authorization and DM/IT interactions and tools
    • Overall excellent client satisfaction, acknowledgment and trust

    Key factors of success

    • ICTA’s expertise in methodology/study design
    • ICTA’s capability to propose innovative solutions for uncommon projects
    • ICTA’s responsiveness

    LESSONS LEARNED to speed up the start-up phase of the next study

    • Adaptability: Learn to work and communicate with a Sponsor who has a marketing-based culture rather than a scientific-based one.
    • Optimal project coordination: Timelines, logistics, sub-contractors management, reporting tools implementation, events management.
    • Team work/team building: Recruitment of patients in sports events by more than 30 ICTA members (from different departments) and external nurses.
    • ICTA is completely able to manage uncommon innovative project, including setting up a digitalized decentralized solution (even though not activated because of a late CNIL authorization).

    CHALLENGES

    KEY CHALLENGESICTA’s SOLUTIONSICTA’s ACHIEVEMENTS
    Patient recruitment: Stringent timelines & Fieldwork during COVID-19 pandemicsAnticipation of a rescue plan : virtual events to assure patient recruitment and data collectionWhile GCP, GDPR and ISO14155 compliant, implementation of digital solutions to ensure subject trial awareness, e-consent/e-signature, race/ non-serious dermatological condition verification and post event data collection) and inter-operability between all electronic tools.
    Subject-centered: self-treated condition, no physician involvedSite staff composed of trained nurses to manage consent during on-event recruitment and via telemedicine for the rescue planCollaboration with subcontractor supplying services of study nurses.
    Compliance with MDR requirementsStudy documents prepared based on ISO14155 guidelinesPreparation of study document templates based on ISO14155:2020
    Sponsors’ multiple requests during KOM, including the following:

    ·  Numerous objectives/endpoints to address multiple claims

    ·  Several products to test and need for individual results per product

    ·  Need to minimise cost/number of hydrocolloid plaster types to provide and respect timelines (e.g. bonus/malus)

    . Specific subpopulations (young, elderly, pregnant/breastfeeding, controlled diabetes)…    		Appropriate study design and methodology to address (almost) all Sponsor’s requests by designing of two feasible studies.Design and development of 2 distinct studies, implementation of randomisation algorithms, homemade questionnaires to assess relevant claims