OBJECTIVES: Implementation science studies the determinants, processes, and strategies that influence the integration of evidence-based interventions into practice and policy and provides support for the development, launch, and real-world implementation of clinical interventions. Implementation science frameworks enable decision-makers to understand the factors and implement strategies to facilitate adoption and access in real-world settings. While the public health domain often incorporates implementation science, this area of research remains underutilized in the development of pharmaceuticals, medical devices, and other technologies.
METHODS: In this concept paper, we discuss using implementation science frameworks to optimize the impact of research throughout the development of a clinical intervention from Phase I through Phase V, provide insights about barriers and facilitators affecting intervention uptake, and guide the development of strategies to address barriers.
RESULTS: Implementation frameworks should be part of an integrated evidence plan. Specifically, during phases I through III, the Consolidated Framework for Implementation Research and the integrated-Promoting Action on Research Implementation in Health Services framework can provide insight on facilitators and barriers affecting intervention implementation, uptake, and adherence. During phases III and IV, the Expert Recommendations for Implementing Change can guide the selection of strategies to address barriers and bolster facilitators. Throughout the development process, the Exploration, Preparation, Implementation, Sustainment framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies provide guidance for understanding how factors impact the effectiveness of an implementation strategy. Feasibility, acceptability, and appropriateness are important outcomes to evaluate the quality of intervention or strategy implementation. Implementation science data collection can be embedded in clinical outcomes research using hybrid designs.
CONCLUSIONS: Using implementation science throughout intervention development can improve drug value and access through the identification of facilitators and barriers, development of strategies, and evaluation of strategies.
