Demonstrating the impact of research is increasingly important in today’s funding and accountability climate. Funders, policymakers, and the public are asking not only what science is being conducted, but what difference it makes [Reference Dorta-González, Rodríguez-Caro and Dorta-González1,Reference Macleod, Michie and Roberts2]. While substantial impact, especially when it involves explicit, definitive clinical outcomes, often requires years to become visible, meaningful change can be seen earlier. This work emphasizes how early integration of the Translational Science Benefits Model (TSBM) enables research teams to identify and communicate near-term benefits during project implementation, rather than waiting until study completion. Intermediate impacts, such as improvements in clinical practice, stakeholder engagement, or public awareness, can alter the trajectory of research [Reference Stallings, Boyer and Joosten3,4]. Communicating these early and projected benefits offers the scientific community opportunities for dialogue, collaboration, and refinement of strategies. Yet, understanding how to demonstrate impact and when to do so is challenging.
The Journal of Clinical and Translational Science [Reference Davidson, Hunt, La Manna and Luke5] and Frontiers in Public Health [Reference Luke, Sarli and Suiter6] have recently published thematic issues focused on the TSBM [Reference Agarwal, de Silva and Agarwal7] for assessing research impact. The TSBM, developed at Washington University in St. Louis, is a structured framework that identifies benefits across four domains: clinical, community, economic, and policy. It also provides a process-oriented roadmap for prospectively planning and evaluating translational benefits across these domains throughout the life of a project.
This research letter illustrates how we applied TSBM to an ongoing research program involving clinical trials: Heart Failure with Reduced Ejection Fraction (HFrEF) Polypill Implementation Trial in Sri Lanka. Our aim is to highlight how the TSBM can be used to plan for, track, and communicate early and anticipated impacts during implementation, providing a clearer temporal context between ongoing and expected outcomes.
Case example: HFrEF Polypill Implementation Trial in Sri Lanka
HFrEF is a leading global public health problem, with significantly higher mortality in low- and middle-income countries (LMIC) [Reference Joseph, Roy and Lonn8]. Despite high-quality evidence that guideline-directed medical therapy (GDMT) consisting of four classes of drugs substantially reduces the risk of mortality in patients with HFrEF, GDMT remains widely underused. A HFrEF polypill containing all four GDMT drugs in one pill may bridge this gap between evidence and clinical practice. The HFrEF Polypill Implementation Trial in Sri Lanka is currently in its early implementation and planning phase, encompassing pretrial mixed-methods research, a type I hybrid pilot randomized clinical trial (RCT), pilot trial process evaluation, and a forthcoming large-scale type I hybrid RCT to evaluate effectiveness, safety, and implementation of a HFrEF polypill-based implementation strategy in Sri Lanka [Reference Martinez-Amezcua, Haque and Khera9]. Our application of TSBM focuses on early identification of benefits already observable – such as stakeholder coordination and regulatory engagement – and on potential future benefits that will evolve as the project progresses.
Early integration of TSBM
To capture intermediary and projected impacts throughout the clinical trial, we embedded four tools from the free, online TSBM toolkit (www.translationalsciencebenefits.wustl.edu/toolkit/#/thetoolkit, Figure 1):
-
• Roadmap to Impact: Defines short, mid, and long-term milestones for patient outcomes, health system uptake, and policy integration.
-
• Benefits 2 × 2: Maps direct and indirect, short and long-term benefits to prioritize early metrics (e.g., feasibility, adherence, pill burden, and provider uptake) over longer-term endpoints like mortality or hospitalization.
-
• Partner Mapper: Identifies and engages stakeholders from clinical, governmental, and industry sectors relevant to the HFrEF polypill.
-
• Impact Tracker: Monitors progress toward potential adoption, including policy references and media engagement.
Planning tools and potential impacts assessed using the Translational Science Benefits Model.
Potential impacts
Clinical – Increase GDMT rates in patients with HFrEF by improving patient-level adherence and decrease provider-level clinical inertia.
Community – Enhance awareness and acceptance of simplified treatment strategies among patients, caregivers, and providers in South Asia.
Economic – Decrease in healthcare utilization and costs related to HF hospitalizations by reducing pill burden and improving adherence.
Policy – Inform national cardiovascular guidelines, support inclusion of HFrEF polypill on essential medicines lists, and inform procurement and reimbursement policies to expand access to HFrEF polypills if demonstrated to be safe and effective in clinical trials.
Each potential impact aligns with the domains represented in Figure 1, and early measurable indicators (e.g., adherence rates, dissemination reach, stakeholder participation) have been identified to track and refine progress over time.
Why timing matters
Integrating impact assessment from the outset provides a framework that may help shape the strategic direction of the HFrEF Polypill program. Capturing and communicating impacts before primary research data are available has created opportunities to align with policymakers, foster partnerships with industry for scalable manufacturing, and build public awareness to facilitate adoption while interest is high. Waiting until research completion could delay these conversations and narrow the window for influence.
By integrating TSBM from the outset, clinical trials can evolve beyond traditional trial metrics to a multidimensional impact narrative that evolves alongside the science.
An iterative assessment process has been defined, consisting of quarterly project reviews using TSBM domains to evaluate progress, document stakeholder engagement, and identify opportunities for refinement.
Stakeholder engagement has been integral to implementation efforts. Partners include the Sri Lankan clinical research organization collaborators, healthcare providers, policymakers, and patients. Their feedback has informed feasibility measures, data collection priorities, and communication strategies for the ongoing trial.
Stakeholder feedback was solicited through a combination of semi-structured interviews, investigator meetings, and iterative review of study materials with implementation partners in Sri Lanka and the United States. Feedback was documented by the study team and used to refine feasibility metrics, data collection priorities, implementation workflows, and communication strategies.
Conclusion
The HFrEF Polypill Implementation Trial in Sri Lanka offers one example of how TSBM can been used to capture translational benefits during a clinical trial research program. Applying the model has helped our team document and communicate early and projected impacts while engaging stakeholders proactively. TSBM’s prospective use provides a structured, iterative, and measurable approach to tracking translational impact across implementation stages.
Acknowledgements
We thank the Center for Public Health Systems Science at the School of Public Health and the Institute for Clinical and Translational Sciences at Washington University in St Louis for their partnership in the development and application of the Translational Science Benefits Model (TSBM). We are grateful to the clinical and research teams in Sri Lanka and the United States who contributed to study design, coordination, and stakeholder engagement. Finally, we acknowledge the contributions of study participants and collaborators whose perspectives informed the development of this work.
Author contributions
Adam Hively: Formal analysis, Investigation, Methodology, Writing-original draft; Anna La Manna: Formal analysis, Investigation, Writing-original draft, Writing-review and editing; Ella Clark: Formal analysis, Investigation, Methodology, Visualization, Writing-original draft; Douglas Luke: Methodology, Writing-review and editing; Asita de Silva: Data curation, Writing-review and editing; Mansi Agarwal: Writing-review and editing; Mark Huffman: Data curation, Writing-review and editing; Abdul Salam: Data curation, Writing-review and editing; Anubha Agarwal: Conceptualization, Funding acquisition, Investigation, Supervision, Writing-review and editing; Emmanuel K. Tetteh: Conceptualization, Methodology, Supervision, Writing-review and editing.
Funding statement
AA is funded by NIH/NHLBI Grant R00HL157687. ALM, EC, and EKT are supported by the Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).
Competing interests
MDH has received travel support from the American Heart Association and World Heart Federation and consulting fees from PwC Switzerland. MDH and AS have an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH and AA have pending patents for heart failure polypills.
Open access
