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
- ePROVIDE™ databases: PROQOLID™, PROLABELS™, PROINSIGHT™
- 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