The evolution and future of integrated evidence planning.

Introduction: Integrated Evidence Planning (IEP) is a strategic approach that optimizes drug development and market access by ensuring evidence generation aligns with regulatory, clinical, and market needs. The increasing integration of advanced technologies, including artificial intelligence/machine learning (AI/ML), natural language processing (NLP), and generative AI is set to revolutionize IEP by enhancing decision-making and improving patient access.

Areas covered: This article examines the role of IEP in drug development, focusing on its application across the product lifecycle, pre-clinical to post-launch. It highlights the integration of various analytical techniques, including descriptive analysis, ML, and causal inference to generate evidence. Challenges in implementing IEP, such as organizational barriers, data accessibility, and needs for specialized software tools are discussed. The evolving role of real-world evidence is emphasized, advocating for IEP as a dynamic, iterative process that adapts to market changes. Additionally, the potential of generative AI and real-time analytics to improve evidence generation and stakeholder collaboration is explored.

Expert opinion: The transformative potential of generative AI in IEP facilitates on-demand insights and conversational data access. However, challenges such as organizational inertia and the need for cross-functional alignment remain. Successful IEP implementation requires strong leadership, stakeholder buy-in, and optimized resource allocation to fully capitalize on its benefits.