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Xtalks, Online
2025-04-24
First-in-human (FIH) oncology trials serve as a pivotal transition from preclinical research to patient care, marking the first step in validating the safety and biological activity of a novel therapeutic in humans. These early-phase studies generate essential data on dosing, pharmacokinetics and preliminary efficacy signals, setting the stage for subsequent clinical development.
FIH oncology trials require careful preparation and strategic implementation from study design and investigational new drug (IND) submission to site startup, patient recruitment and cohort management. To ensure success, sponsors must navigate a host of challenges to ensure safety, timeliness and scientific validity.
This webinar will highlight key considerations and best practices for designing and executing FIH oncology trials, offering practical solutions to help sponsors navigate the regulatory, operational and clinical hurdles inherent to these studies. The key topics will include:
Preparing a robust IND package
Developing a clear plan for dose escalation
Streamlining site initiation and patient recruitment
Managing cohorts and safety review committees
Register for this webinar to explore best practices such as regulatory preparation, site initiation, cohort management and safety monitoring for designing and executing first-in-human oncology trials.
Keywords: Clinical Trials, Cancer, Drug Development, Clinical Research, CRO, Oncology, Cancer Research, Oncology Trials, Oncology Clinical Trials, Therapeutic Areas, Decentralized Clinical Trials, DCT
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Organized by:
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Xtalks |
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Invited Speakers:
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Bin Pan, PhD, Executive Director of Operational Strategy, Ergomed Clinical Research
Juliet Moritz, Senior Vice President of Strategic Solutions & Patient Centricity, Ergomed Clinical Research
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Deadline for Abstracts:
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2025-04-24
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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