Expert Insights on Pathology in Clinical Trials
These 10-minute expert-led videos, originally presented at the European Congress of Pathology 2024 as part of a Lilly-sponsored industry symposium, highlight the vital role of pathologists in the success of clinical studies.
Covering topics such as biomarker strategy, regulatory requirements, and real-world data, each talk offers practical guidance on integrating pathology into clinical trial design and execution.
The PCC thanks Lilly for providing these materials and the contributing experts for sharing their knowledge.
A Story of Tandem Development and Shared Decisions
Presented by Professor Lorenzo Gerratana, MD
Department of Medicine (DMED) – University of Udine
Department of Medical Oncology – IRCCS CRO Aviano National Cancer Institute
The Liquid Biopsy Research Group (LBRG)
Precision Medicine Academic Consortium (PMAC)
Professor Gerratana discusses how clinical trials increasingly rely on biomarker-driven strategies, from early-phase studies to real-world data integration. He explains how predictive, prognostic, and emerging biomarkers are shaping trial design, treatment sequencing, and patient selection, highlighting the essential collaboration between clinicians and pathologists.
Watch to explore how biomarkers are reshaping oncology trials and why real-world evidence is key to next-generation cancer research.
Biomarker Testing in Clinical Studies
Presented by Professor Giancarlo Pruneri, MD
Fondazione IRCCS Istituto Nazionale Tumori
School of Medicine, University of Milan
In this video, Professor Pruneri explores how biomarker testing is shaping modern clinical trials, with a focus on precision oncology. He discusses the shift toward real-world data, the expanding use of multi-omic testing, and the growing role of pathology labs in biomarker-driven research.
Watch to understand how pathology can drive innovation in clinical trials through accurate, accredited, and future-ready biomarker testing.
In Vitro Diagnostic Regulation (IVDR) Requirements for Clinical Studies
Presented by Professor Albrecht Stenzinger, MD PhD
Institute of Pathology, University Hospital Heidelberg
Center for Personalized Medicine, University Hospital Heidelberg
In this short talk, Professor Stenzinger outlines the essential IVDR requirements for labs involved in clinical trials across the EU. He explains how local in-house diagnostic tests can remain compliant under IVDR, clarifies the distinction between CE-marked and in-house devices, and emphasizes the critical link between IVDR and clinical trial eligibility.
Watch to understand how to align your laboratory practices with evolving EU regulations for molecular diagnostics in clinical research.
Originally commissioned by Lilly Medical, these videos are intended for healthcare professionals and are provided for medical, scientific, and educational use. Please refer to the videos for full disclaimers and disclosures.
PCC-195 | Date: July 2025