COA instrument development or modification
With extensive experience in developing all types of Clinical Outcome Assessment (COA) measures (including Patient-Reported Outcome; PRO, Observer-Reported Outcome; ObsRO, Clinician-Reported Outcome; ClinRO and Performance Outcome; PerfO measures), Adelphi Values is well-positioned to be a strategic partner for the development COA measures that are ‘fit for purpose’ for use in a variety of contexts. We work with sponsors to develop COAs assessing a broad range of concepts that can be relevant for assessment in clinical trials, observational research and clinical practice, including: symptoms, physical functioning, domains of health-related quality of life and treatment satisfaction.
Any instrument development should start with consideration of both the ‘Concept of Interest’ and the ‘Context of Use’. We must ask whether we are measuring the right outcome(s), in the right way for the given context. We understand the importance of ensuring instrument development/modification is grounded in qualitative research with patients to ensure content validity. However, the clinical perspective and intended use of any COA are also vitally important.
With extensive experience in developing all types of Clinical Outcome Assessment (COA) measures (including PRO, ObsRO, ClinRO and PerfO measures), Adelphi Values is well-positioned to be a strategic partner for the development COA measures that are ‘fit for purpose’ for use in a variety of contexts. We work with sponsors to develop COAs assessing a broad range of concepts that can be relevant for assessment in clinical trials, observational research and clinical practice, including: symptoms, physical functioning, domains of health-related quality of life and treatment satisfaction.
Any instrument development should start with consideration of both the ‘Concept of Interest’ and the ‘Context of Use’. We must ask whether we are measuring the right outcome(s), in the right way for the given context. We understand the importance of ensuring instrument development/modification is grounded in qualitative research with patients to ensure content validity. However, the clinical perspective and intended use of any COA are also vitally important.
With our strong heritage in instrument development, we are highly focused on developing items, instructions, response scales and recall periods that will be easy for patients to understand and appropriate and relevant for the intended assessment concept. We have an in-depth understanding of not just the standards that are required by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for any instrument that might be used to support label claims, but also considerations that are important for COAs to be used for other purposes. No matter the intended mode of administration (paper and pencil, electronic administration such as a tablet or bring your own device [BYOD], we have the expertise and know-how to advise on the successful adaptation and implementation. Recognizing the complexities of clinical development, we are pragmatic while keeping both the regulators and scientists in mind and patients front and center.
With our strong heritage in instrument development, we are highly focused on developing items, instructions, response scales and recall periods that will be easy for patients to understand and appropriate and relevant for the intended assessment concept. We have an in-depth understanding of not just the standards that are required by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for any instrument that might be used to support label claims, but also considerations that are important for COAs to be used for other purposes. No matter the intended mode of administration (paper and pencil, electronic administration such as a tablet or bring your own device [BYOD], we have the expertise and know-how to advise on the successful adaptation and implementation. Recognizing the complexities of clinical development, we are pragmatic while keeping both the regulators and scientists in mind and patients front and center.
