Document Type
Dissertation
Date of Degree
10-1-2026
Primary Advisor
Sabrina Figueiredo
Abstract
Background: The development of a new medicine does not end with regulatory approval. After approval, additional decisions about reimbursement, guideline or pathway placement, prescribing, and appropriate use influence whether a medicine is adopted into clinical practice. These decisions may require evidence beyond the safety and efficacy data generated for regulatory approval. Integrated evidence generation and planning (IEGP) has emerged as a cross-functional, lifecycle-oriented approach for identifying, prioritizing, coordinating, and governing evidence needs, but the published literature remains largely conceptual and prescriptive. This dissertation characterized how IEGP is understood and practiced within large pharmaceutical companies and examined the factors that shape product evidence strategy.
Methods: A descriptive qualitative study included 19 senior medical affairs and related medicine function leaders employed across seven of the 15 largest pharmaceutical companies. Semi-structured interviews averaged 82 minutes and were analyzed using template analysis with a hybrid deductive-inductive approach. The Consolidated Framework for Implementation Research (CFIR 2.0) served as a sensitizing framework, and Normalization Process Theory was applied post hoc as an interpretive lens.
Results: Five themes described IEGP’s meaning and formalization, variation in integration, stakeholder prioritization, evidence gap decisions, and execution and feedback. Participants described IEGP as a document, a cross-functional process, and a broader strategic orientation. Its influence depended on authority, ownership, early cross-functional involvement, leadership, resources, tools, and individuals. Stakeholder prioritization followed a regulator-first pattern. Payer and provider needs and guideline or pathway considerations varied by asset, lifecycle stage, and market context. Patient- specific evidence was generally sequenced later within the approval—access—adoption sequence. Evidence gaps were judgments about whether available evidence was sufficient to inform a stakeholder or internal decision related to development, market access, launch positioning, or clinical use. Gaps were externally tested, when possible, prioritized by impact, feasibility, timing, budget, and evidence type, then assigned act, monitor, or defer dispositions. Recommendations to act became approved evidence activities only after authorization, ownership, sequencing, and resourcing. Organizations more consistently tracked execution than assessed whether the resulting evidence informed stakeholder decisions. Feedback into later planning was inconsistent and often person dependent. The SELECT Model organized these decision points and showed how lifecycle stage and organizational conditions shape product evidence strategy.
Conclusion: IEGP was recognizable across participants’ accounts, but its meaning, formalization, and influence on evidence decisions varied considerably. The findings shift attention from whether an integrated evidence plan exists to how organizations identify and frame evidence gaps, prioritize them, translate recommendations into approved evidence activities, and revisit earlier decisions across the product lifecycle. The SELECT Model makes these decision points and the conditions shaping them visible. This study clarifies the organizational work behind evidence strategy and generation and provides a basis for evaluating and refining IEGP across development, commercialization, and post-launch practice.
Recommended Citation
Porter, Thomas Matthew, "Integrated Evidence Strategy in the Development, Commercialization, and Clinical Adoption of New Medicines" (2026). Doctor of Philosophy in Translational Health Sciences Dissertations. Paper 49.
https://hsrc.himmelfarb.gwu.edu/smhs_crl_dissertations/49
Open Access
1
Comments
©2026 by Thomas Matthew Porter. All rights reserved.