Patient-Centered Outcomes

Literature and critical instrument reviews are both central components to the development and selection of COAs for inclusion in studies. The Adelphi Values Patient-Centered Outcomes team have vast experience performing all types of COA literature and instrument reviews to meet a range of purposes, including: Reviews of qualitative evidence to… Read More

Adelphi Values are leaders in the conduct of qualitative research to obtain patient experience data to support the development and content validity testing of COAs.  In 2018, Adelphi Values researchers collected qualitative data from more than 700 participants (patients, caregivers, clinicians) across a wide range of conditions. Our experts have… Read More

Adelphi Values have experience of developing all types of Clinical Outcome Assessments (COAs) including PRO, ObsRO, ClinRO and PerfO  measures.  In addition we develop ‘fit for purpose’ instruments to assess the broad range of concepts that can be relevant for assessment in clinical trials and general clinical practice, including: symptoms,… Read More

As electronic data capture becomes commonplace in clinical trial design, regulatory agencies are asking for data to demonstrate the equivalence of eCOAs and their paper counterparts. Generating such evidence prior to trial commencement saves time in addressing regulatory questions later. Several senior members of our team are well-versed in the… Read More

PRO and other COA data is complex with multiple time points, multiple domains and missing data often related to the outcome of interest. The statistical techniques required to analyse PRO/COA data therefore require specialist expertise, particularly as there are no accepted standards for the analysis of PRO/COA data and a… Read More

Appropriate clinical outcome assessment (COA) label claims rely on robust instrument selection, development and validation in the targeted Context of Interest and to a standard that meets current regulatory expectations. Regulatory approval is dependent on assessment of relevant and important outcomes (the ‘concept of interest’) in the right population (‘context… Read More

Scientific dissemination of PRO/COA trial results or the development or evaluation of PRO/COA instruments is of considerable value to establish the credibility of the research.  Such scientific dissemination can take the form of: articles in peer reviewed journals conference abstracts and associated posters or presentations Workshops and webinars. Adelphi Values… Read More

Support in measurement strategy development With our in-depth knowledge of regulatory and reimbursement authority requirements and expectations for PRO instruments and endpoints we are the ideal partner to help you with all aspects of measurement strategy development.  This can vary from putting together an aspirational measurement strategy for inclusion in… Read More