Systematic or targeted literature reviews to understand burden of illness and to identify existing clinical outcome assessment (COA) instruments for measuring symptoms, functioning or health-related quality of life (HRQoL). Qualitative research to understand patients’ experience of symptoms and impacts of their condition. Development and evaluation of COA instruments such as patient-reported outcome (PRO), observer-reported outcome (ObsRO) and clinician-reported outcome (ClinRO) measures.
Gap analyses of relevant COA instruments to evaluate if they are fit for purpose for use in specific clinical trial contexts. Recommendations on selecting existing COA instruments or developing a de novo instrument to meet the specific context of use. Strategic advice on overall COA endpoint strategy and evidence needed to meet regulatory requirements. Support with COA evidence dossiers and regulatory communications throughout the drug development process.
Identification, development and validation of measures to assess medication adherence. Advice on assessment of adherence in clinical trials and real-world studies.
Dissemination via peer-reviewed publications, conference presentations, white papers.