The early-phase oncology clinical trial landscape is constantly evolving, influenced by shifts in regulatory guidance such as Project Optimus and multiregional clinical development programs.
Project Optimus emphasizes dose optimization earlier in the trial process, leading to more complex study designs that require larger sample sizes and a broader global footprint. Initiatives to refine dosing strategies to enhance patient safety and efficacy necessitate more intricate planning and execution of clinical trials.
The focus on dose optimization means that researchers must carefully balance the need for robust data with the practicalities of patient recruitment and retention, often across multiple countries and regulatory environments. Operational execution of these trials involves coordination of numerous factors, especially during study startup and planning of trial logistics.
Managing early-phase oncology clinical trials has become increasingly complex, necessitating a strong command of country- and site-level feasibility, ethics, and informed consent to ensure success. Getting global study teams up and running, then requiring them to successfully navigate cultural differences and be well-versed in local regulatory, data privacy, and ethical requirements, can impact study startup, site selection, and patient recruitment.
Understanding these numerous factors and mitigating various risks are essential for early-phase oncology trials to ensure patients benefit throughout because they represent the end goal. In this webinar, the experts will share lessons learned, best practices and tangible examples from their experiences in operationalizing global, complex early-phase oncology trials. This event provides valuable insights into overcoming the common hurdles faced in these trials and offers strategies to enhance efficiency and effectiveness.
The panel of experts in this webinar includes:
- Keya Watkins, Senior Vice President, Catalyst Oncology, Catalyst Clinical Research (Moderator)
- Marcia Milholen, Vice President, Central Site Services, Catalyst Clinical Research
- John McAdory, MHA, Vice President, Clinical Operations, CG Oncology
- Dora Ferrari, Vice President, Clinical Operations, Curis
