As the radiopharmaceutical research and development landscape continues to advance, so do the complexities and challenges associated with clinical trials. Conducting radiopharmaceutical trials presents a unique set of obstacles, such as the challenge of capturing unique radiation induced toxicities in the context of enrolled patients’ overall radiation exposure. This requires an understanding of enrolled patients’ cumulative radiation exposure from previous radiation treatments and current studies. For clinical radiopharmaceutical studies, the broader team must understand the background of radiation dosimetry, radiation toxicity, normal organ dose constraints and how to capture these metrics within clinical trial data management.
In this webinar, Medpace medical, operational, regulatory and core lab experts will explore considerations for radiation toxicity and analyze previous radiopharmaceutical case studies and draw on their integrated, global experience to examine strategies to successfully operationalize complex radiopharmaceutical trials and increase the probability of clinical and regulatory success.
Register for this webinar to learn how Sponsors in the pharma and biotech industry can overcome challenges associated with complex radiopharmaceutical trials through medical, regulatory and operational considerations, including engaging an experienced and full-service clinical research partner with cross-functional expertise.
Follow along with experts from Medpace, Jess Guarnaschelli, MD, Senior Medical Director, Medical Department; Daphnée Villoing, PhD, Dosimetry Specialist and Senior Project Manager, Medpace Core Labs; Deborah Hirscher, MBA, MS, RN, ARNP, FNP, Senior Director, Clinical Trial Management; Stephanie Millin, PhD, Clinical Trial Manager; and James Thomas, BSc (Hons), MA, Senior Director, Regulatory Submissions, in the newly released webinar:
Radiation Toxicity- Considerations for Implementing Radiation Dose Limits in Radiopharmaceutical Trials from Medpace on Vimeo.