Difficulties of Yesterday, Opportunities for Today
The confluence of increased data generation capabilities, increased regulatory and reimbursement recognition, and advanced analysis has opened the door to trial augmentation.
Decreasing Clinical Trial Design and Implementation Costs
Enhancing efficacy or safety signals through the incorporation of epidemiological data can offer significant advantages in terms of cost and time savings when compared to traditional prospective randomized trials. Through integrating external data, we pinpoint both overall trends and variations within specific subpopulations well before the formal trial results are available, facilitating earlier go/no-go decisions. Further, these data and associated analyses can also be used for external communication strategies, including formal regulatory or reimbursement submissions.
Global Health Through Global Reach
Global reach is paramount when it comes to diversity, equity, and inclusion initiatives. These crucial plans often demand the engagement of populations that can be challenging to either recruit or find data on within a single country. Moreover, as countries become more attuned to the unique needs and nuances of their diverse communities, there is a growing need for country- or region-specific data to underpin these efforts. The pursuit of true inclusivity extends beyond borders, prompting organizations to embrace a global perspective and tailor their strategies to address the rich tapestry of human experiences worldwide.
Evidence Generation for Rare Diseases
As advancements in molecular biology and precision medicine continue to grow, the landscape of rare diseases is evolving rapidly. This progress has led to the emergence of smaller, more specialized patient populations. Conventional clinical trial methodologies often struggle to adapt to these unique and fragmented populations. To bridge this gap, it is essential to leverage the valuable data resources provided by diverse data sources, such as patient registries and patient advocacy organizations. Integrating patient insights into the formal trial design process early during development is a pivotal step in enhancing the evidence generation process for rare diseases.
