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The International Society of Quality of Life (ISOQOL) Measuring What Matters Symposium, held in Washington DC in July 2016, aimed to bridge the needs of patients and clinicians with industry and regulatory requirements.

A common theme was the need for patients to have “a voice at the table” throughout the clinical drug development process in terms of understanding their unmet treatment needs and prioritising relevant outcomes assessed in clinical trials. Patient representatives highlighted the importance of engaging with patients and caregivers to inform key aspects of clinical trial design. In addition, recognition was given to the importance of insights that patients can provide regarding regulatory decision making.

Industry leaders and speakers from the FDA also highlighted the need for scientifically robust patient research to develop patient centred measurement strategies for clinical development. Specifically, qualitative research which can inform target product profiles (TPP) and identify measurement outcomes that really matter to patients, their families, and their caregivers. This can allow sponsors and researchers to select, develop and validate Patient Reported Outcome/Clinical Outcome Assessments (PRO/COA) that meet the needs of patients and also meet regulatory standards to support clinical trial endpoints.

Speakers discussed the Clinical Outcome Assessment Qualification Program; COA qualification represents a conclusion that within the stated context of use, results of assessment can be relied upon to measure a specific concept and have a specific interpretation and application in drug development and regulatory decision-making and labelling[1]. Interestingly, it was highlighted that that joint FDA and EMA qualification routes are available which harmonise expert advice and provides feedback to sponsors or consortia from both agencies.

PRO development is an iterative process which seeks to improve and refine a measure thus ensuring that the most relevant, accurate, and reliable assessment of patient outcomes is possible. The symposium provided perspectives from multiple stakeholders involved in PRO/COA including patients, researchers, sponsors, clinicians, and regulators.

At DRG we know how important measuring patient benefit is as part of your clinical trial PRO strategy in getting novel treatments to market. If you would like to find out more, or need help with any aspect of PRO selection or development, please visit our website at: www.decisionresourcesgroup.com/VGC or contact one of our clinical outcomes assessment team on Access@TeamDRG.com

[1] http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm