A well-designed Clinical Outcome Assessment (COA) strategy is critical to supporting regulatory decision-making. Yet COA strategies are often developed too late in the planning process, creating challenges that can compromise endpoint relevance, delay trial timelines, and limit the value of the evidence generated.
This webinar will identify common pitfalls in developing COA strategies and will address practical questions sponsors face, such as:
- What decisions need to be made before an endpoint is locked?
- What evidence is needed to support instrument selection?
- When is it better to use an existing COA versus develop a new one?
- How early should localization and linguistic validation be built into global study planning?
Learning objectives:
- Identify the COA decisions that should be made early, and the consequences of making them too late
- Select or develop COA instruments that align with programme objectives
- Address regulatory evidence expectations
- Anticipate localization and linguistic validation requirements for global studies
- Mitigate operational and regulatory risks through proactive planning
Featuring Insights from
John Kealy
,
PhD
John Kealy is a behavioural neuroscientist with expertise in neuropsychiatric and neurodevelopmental disorders. He has extensive clinical and preclinical experience in the drug discovery space, pioneering new methodologies including biosensors, neurochemical detection, and the development of translational biomarkers. At Mapi Research Trust, John leads the Patient-Centered Endpoint Intelligence (PACE) team providing consulting services around Clinical Outcome Assessments and Digital Health Technologies in clinical trials.
Anne Sophie Michel
,
PharmD
Anne-Sophie Michel is a pharmacist by training and a Senior Outcomes Researcher at ICON with expertise in Patient-Focused Drug Development (PFDD). Her work focuses on incorporating the patient perspective into clinical research through robust qualitative methodologies and fit-for-purpose outcome assessment strategies. She advises sponsors on Clinical Outcome Assessment (COA) strategies and leads qualitative research projects, including interviews conducted alongside clinical trials, across a wide range of therapeutic areas to support drug development and regulatory decision-making.
Cristina Vasile
Cristina Vasileis an Account Manager at ICON Language Services with over 10 years of experience in linguistic validation for clinical outcomes assessments. She specialises in supporting complex global trials, helping sponsors align translation and validation strategies with early endpoint decisions to mitigate regulatory risk and deliver against critical study timelines.
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