Accurate and reliable signal detection remains a critical challenge in Alzheimer’s disease (AD) clinical trials, particularly when targeting the preclinical phase where research teams must leverage different scales and operational approaches compared to studies of symptomatic AD .
Participants in these studies will be cognitively-unimpaired or display only very subtle, prodromal cognitive changes, requiring extremely sensitive assessment instruments capable of detecting small, incremental changes over time. Furthermore, slow progression of AD necessitates longer trial duration to observe meaningful change, which increases risk for participant attrition and of inter/intra rater variability. These realities can lead to more “noise” in trial data, potentially obscuring meaningful clinical outcomes and hindering development of novel therapeutics if effective signal detection strategies are not implemented.
In this webinar, attendees will learn tactics and hear case examples of various strategies clinical trial teams are deploying to improve data signal clarity and enhance the reliability of their study outcomes in preclinical AD.
Presenters will describe the processes and benefits of:
- strategic rater selection, robust qualification criteria, and tailored training programs
- central monitoring using both algorithmic, data-based review, as well as risk-based expert review of rater performance to flag errors and provide timely feedback to raters
- remote, decentralized assessment options for preclinical populations such as central review and central rating using small groups of expert clinicians to administer/score scales remotely, enabling those sites lacking specialized raters to participate, increasing participant diversity, and reducing participant burden
- eCOA form optimization to prevent common rater errors and enhance user experience for raters with effective data capture tools
Join Kaycee Sink, MD and Svenja Wacker, PhD, who will share first-hand experiences with the nuances of administering clinical outcome assessments to this specific patient population and provide tactics to deploy strong endpoint data quality programs for preclinical AD trials.
WHAT YOU WILL LEARN
- Guidance on strategic rater selection, qualification, and tailored training programs
- Methods for effective central monitoring via algorithmic, data-based review and risk-based expert review
- Considerations for decentralized testing options to reduce site and patient burden and optimize data quality.
WHO SHOULD ATTEND?
- Executives, directors, scientists and managers from pharma, biotech and CROs responsible for global Alzheimer’s Disease clinical trials including:
- Research and Development
- Clinical Operations
- Clinical Science
- Outcomes Research
- Outsourcing and Procurement
- Project Management
- Clinical Trial Planning and Optimization
- Medical Affairs
Speakers
Kaycee Sink, MD, MAS
Chief Medical Officer
Svenja Wacker, PhD
Neuropsychology Science Director
Details
Monday, June 30, 2025 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central) 60 min
