The Evolution and Future of Integrated Evidence Planning

The healthcare landscape is evolving, and integrated evidence planning (IEP) is becoming crucial for demonstrating the value of new treatments and expediting patient access. By incorporating the needs of all customer groups, IEP leads to faster approval, reimbursement, and access to care. It ensures efficient use of resources and generates holistic evidence for stakeholders like patients, regulatory authorities, and healthcare providers.

Companies face challenges such as lack of cross-functional alignment, short-term focus, poor data integration, and functional/geographic silos. Emerging barriers include data complexity and regulatory acceptance of real-world data (RWD).

Successful IEP implementation involves four pillars:

• People: Cross-functional teams with expertise from various functions.
• Process: Standardized, collaborative, and transparent processes.
• Platform: Unified platforms for data integration and evidence generation.
• Analytics: Advanced analytics to optimize resource allocation and study design.

Increased use of RWD/RWE, advanced analytics (AI/ML, NLP), patient-centric approaches, and integration of diverse data sources are trending. Collaborative partnerships are also fostering innovation. Incorporating patient-reported data, using generative AI for data harmonization, and employing digital twins for clinical trials are emerging trends. These innovations aim to enhance decision-making and streamline drug development.

Integrated evidence planning has the potential to revolutionize drug development and improve patient outcomes. Future trends include increased technology adoption, advanced analytics, and a focus on "whole patient health." It is imperative that IEPs be living, iterative documents that can adapt to changing market dynamics and regulatory landscapes.

Won Chan Lee, Ph.D., Principal and Practice Lead of RWE/HEOR/ES at Axtria, has guided numerous biopharma companies in crafting and executing robust Integrated Evidence Plans. In this insightful paper, he delves into the evolution and future trajectory of IEP, highlighting the anticipated surge in technology adoption and the integration of patient-reported data with advanced analytics, including AI/ML, NLP, and GenAI. He underscores the importance of employing diverse analytical approaches, ranging from fundamental descriptive analysis to predictive machine learning and counterfactual causal inference analysis, for a well-structured IEP. The potential trend of combining rapid-cycle analytics with GenAI to generate on-demand insights is also explored, emphasizing the critical role of a comprehensive understanding of these integrated analytical methods in shaping effective IEPs. In a previous thought-provoking whitepaper, "Seeing the Whole Elephant: Integrated Advanced Data Analytics in Support of RWE," Won has synonymized insight generation from RWD with the fable of the six blind men and the elephant.

Download the white paper to learn more.

You’ll gain insights from:

Won Chan Lee, Ph.D
Principal and Practice Lead, RWE/HEOR/ES at Axtria Inc.

Chris Blanchette, Ph.D
Vice President, Clinical Data Science
& Evidence at Novo Nordisk

Shibani Pokras
Senior Director and Global Process Owner, Integrated Evidence Planning
at GSK

Javed Shaikh
Director, RWE/HEOR/ES
at Axtria Inc.

Jared Miller
Associate, RWE/HEOR/ES
at Axtria Inc.