Beyond the Protocol: Advancing Patient- and Caregiver-Centered Approaches in Neurodegenerative Clinical Trials

Neurodegenerative clinical trials present unique challenges that extend beyond scientific and operational complexity. Disease progression, caregiver responsibilities, travel burden, complex assessments and patient availability can all influence recruitment, retention and overall clinical trial experience. As the field continues to advance, incorporating the perspectives of patients and caregivers into clinical development is increasingly important to designing studies that are both scientifically rigorous and feasible for the populations they aim to serve.

This webinar will explore practical strategies for integrating patient- and caregiver-centered approaches throughout the clinical development process, from protocol development, including opportunities to incorporate advocacy feedback early and align study endpoints and assessments with the realities of living with neurodegenerative disease.

The discussion will also examine key barriers to participation and approaches to improving recruitment and retention. The featured speakers will share operational strategies informed by experience across different phase neurodegenerative programs, including considerations for site selection and readiness, visit burden, complex assessments and global coordination.

As neurodegenerative development increasingly spans international populations, the webinar will address the additional considerations involved in conducting patient-centered studies across borders. Differences in patient engagement expectations, ethical considerations and regulatory requirements can affect how patient and caregiver perspectives are incorporated into clinical research. Ensuring that patient-centered strategies align with global regulatory standards is essential for successful execution.

Finally, the webinar will connect patient-centered protocol design with real-world study execution, highlighting lessons learned from programs across different phases. By bringing together clinical, operational and patient-focused perspectives, the discussion will demonstrate how thoughtful trial design and execution can improve the experience for patients and caregivers while supporting the scientific and operational objectives of a clinical trial.

Attendees will gain actionable insights into designing and executing neurodegenerative clinical trials that balance scientific rigor, operational feasibility and the needs of patients and caregivers that move beyond the protocol to create a more meaningful clinical trial experience.

Register for this webinar to learn how patient and caregiver perspectives can inform the design and execution of neurodegenerative clinical trials.

Speakers

Dr. Teresa León Colombo, MD, PhD, Vice President, Medical Department, Medpace

Dr. Teresa León Colombo is a board-certified Neurologist based in Madrid, Spain. With 25+ years of industry experience specializing in neurodegeneration and rare neuroscience disorders, Dr. León Colombo provides strategic medical leadership across global clinical development spanning Phase I-IV, partnering with sponsors to advance innovative therapies from early development through registration and commercialization.

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Valentina Valsecchi, Sr. Director, Clinical Trial Management, Medpace

Valentina brings 25+ years of industry experience with CROs and extensive expertise in global study oversight across a range of therapeutic areas, with a focus on neurology indications. She leads a cross-functional subspecialty group focused on neurodegenerative trials and has extensive experience supporting the clinical development of therapies in this space. Based in Milan, Italy, Valentina brings a global perspective to the design and delivery of complex clinical trials.

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Melanie Falcon, BSc, Manager, Patient Recruitment, Medpace

Melanie began her career as a CRC at the Ohio State University, where for six years she oversaw rare disease trials in Hematology. She has now been with Medpace for eight years, starting as a CRA in 2018 with specializations in oncology and rare disease, before moving to PRR in February of 2022. Over the past four years, she has managed several studies in oncology, rare disease and pediatrics.

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James Thomas, BSc (Hons), MA, Sr. Director, Regulatory Submissions, Medpace

James has a combined scientific (Biomedical Sciences, BSc), legal (Master’s degree in Biotechnological Law and Ethics) and ethical background to conduct and oversee submissions and approvals in 65+ countries based on his 20+ years of experience across all phases of development. He specializes in operationally dynamic and innovative trials, including support across a range of neurologic and neurodegenerative indications.

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