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IQVIA’s EPON Paves the Way for More Efficient Early Phase Oncology Research
Sep 01, 2023
IQVIA’s EPON Paves the Way for More Efficient Early Phase Oncology Research
Navigating drug development in oncology is a complex and intensive process. While there are certainly challenges sponsors face in later phases, early phase oncology (EPO) studies have their own set of distinct obstacles. If not addressed, these can amplify the complexity in later phases. Such challenges include:
- A non-homogenous patient population: Many EPO studies apply an “all-comers” approach to patient recruitment, which introduces variability within the population. It’s crucial to collaborate with experienced investigators who not only have access to suitable patients, but also possess a deep understanding of their patients and the impact variability can have on signals seen during the study. Moreover, there is an emerging trend of biomarker/mutation driven populations being recruited into studies of targeted therapies, adding another layer of complexity to identifying the right patient.
- Intensive study procedures: EPO studies often have intensive PK sampling and biopsy requirements. The data generated from these procedures is critical to the success of the product under development. Therefore, it’s imperative to select sites with experience managing this additional burden, which should be a high priority for sponsors.
- Speed: Most sponsors face fierce competition from other companies, so selecting the right dose(s) for further development needs to happen quickly. Not only does site start up need to be fast, but investigators and sites must also stay engaged throughout the dose escalation process. This engagement involves active participation in the Safety Review process (by providing timely data and, in many cases, being an active member of the Safety Review Committee), proactive patient identification ahead of cohort opening and ensuring dosing is completed on time.
As the landscape of EPO drug development continues to evolve, increased pressure is placed on study timelines and mitigating risks. To overcome these pressures, it is recommended that companies turn to experts who can help.
IQVIA’s Global Early Phase Oncology Network (EPON): Playing a Pivotal Role in Streamlining Early Oncology Studies
IQVIA’s EPON is a network of qualified Phase I oncology sites that operate in close alignment for fast site activation and improved patient recruitment. By utilizing pre-identified experienced sites, site selection timelines can be reduced, increasing operational efficiencies.
In addition, EPON is not confined to a specific region. Rather, its reach spans across the globe, which is vital given the increasing competition for competent sites on EPO studies. This expansive network allows for a broader scope of research and access to a wider pool of patients, enhancing the quality of data collected.
Selecting the right sites is crucial to the success of any study. EPON takes this into account and leverages IQVIA’s established relationships to increase the probability of success. These relationships not only facilitate smoother studies, but also contribute it building a more robust and reliable network.
Advantages of EPON: More than Just Sites
IQVIA's EPON provides a multitude of benefits that go beyond just a list of sites. These advantages include:
- Stable Relationships: Over a decade of strong ties with sites, enabling deep understanding and smooth collaborations.
- Detailed Site Information: Comprehensive profiles for each site, aiding in the creation of efficient study tools.
- Experts: EPON managers provide valuable insights into patient populations, pathways, and potential protocol challenges.
- Key Connections: Strong relationships with Investigators and KOLs who can offer early insights into the protocol.
- Logistical Efficiency: Well-mapped sites and standardized processes help eliminate startup and delivery hurdles as well as help to expedite Phase I trials.
- Continuous Improvement: Proactive identification and discussion of potential areas for improvement.
- Understanding of Site Operations: Deep knowledge of each site's workings and startup needs, contributing to faster turnaround.
- Aligned Processes: Standard budgets, agreed CTA wording, and other aligned processes for speedier outcomes.
Conclusion
Early phase oncology research comes with many challenges. However, with IQVIA's EPON, it becomes easier to navigate these complexities. With well-established relationships that span over a decade, EPON ensures seamless collaborations and profound understanding of each site. The comprehensive site profiles, a team of specialized experts, and insightful support further streamline the process. This holistic approach not only enables the effective execution of trials but also paves the way for groundbreaking advancements in oncology.