What is Patient-Centered Endpoint Intelligence?

Making the best decisions for your patient-centric endpoint strategy always starts with asking the right questions.

Navigating the patient endpoint landscape is time-consuming and can be confusing, especially in this fast-growing field of patient-centered drug development and clinical research. Making decisions on the selection of an appropriate set of patient endpoints (questionnaire-based, diaries, or digital endpoints) requires consideration of many factors including study objective, regulatory requirements, as well as specific trial design factors and often becomes a daunting task for sponsors.

Our team of experts performs a targeted but comprehensive landscape analysis. It is customized to answer your key strategic questions through well-known and transparent methodology that will accelerate submission and facilitate the review process at regulatory agencies. We work in close collaboration with our clients in a manner that is in line with their budgets and timelines.


Examples of strategic questions covered by patient-centered endpoint intelligence

  • What are the relevant concepts that describe patients’ experience of the disease from the patient or the HCP perspective? What measures matter for the patients?
  • Which COAs have been used in specific indications (questionnaire-based, diaries, or digital endpoints)?
  • What are the content validity and psychometric properties of these specific instruments and how are they scored?
  • What were the COA strategies (patient endpoints) used by other researchers and/or competitors?
  • Have competing drugs obtained a COA claim from the FDA, the EMA or other health authorities?
  • Have competitors used a COA during the development of their product which was not recognized in the label?
  • Which COAs are recommended by health authorities, HTA bodies?


Examples of sources used for COA landscape analysis

  • Biomedical databases (Medline, Embase, PsycInfo, Cochrane, EconLit)
  • ClinicalTrials.gov, TrialTrove
  • Websites of health authorities, health technology assessment (HTA) agencies, clinical societies, patient advocacy organizations
  • Grey Literature


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