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In Silico Clinical Trials for Cardiovascular Disease
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Embedding Implementation Science in Clinical Trials: A Framework for Academic-Life Science Partnerships.

Tyler L Cope1,2, Emily C O'Brien3,4, Neha J Pagidipati3

  • 1Duke Clinical Research Institute, 300 West Morgan Street, Suite 800, Durham, NC, 27701, USA. tyler.cope@duke.edu.

Pharmaceutical Medicine
|August 31, 2025
PubMed
Summary
This summary is machine-generated.

Implementation science can accelerate therapy adoption by integrating early with life science partners. Proactive engagement in clinical trials addresses real-world challenges, improving treatment accessibility and commercial success.

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Area of Science:

  • Implementation Science
  • Translational Research
  • Health Services Research

Background:

  • Academic implementation science in the USA traditionally focuses on late-stage research.
  • Limited early engagement with life science partners misses opportunities to address real-world implementation challenges proactively.
  • Early integration of implementation science into drug development can improve therapy uptake.

Purpose of the Study:

  • To explore how implementation scientists can better support new therapy development and delivery with life science partners.
  • To propose a framework for collaboration between implementation scientists and life science partners.
  • To highlight the benefits of early integration throughout the clinical trial lifecycle.

Main Methods:

  • Conceptual framework development for collaboration.
  • Analysis of opportunities for early integration in clinical trials.
  • Discussion of implementation science's role in strengthening trial design and informing stakeholder selection.

Main Results:

  • Early integration identifies healthcare system constraints, clinician barriers, and patient acceptability issues.
  • Implementation science can enhance trial design, site selection, and readiness for real-world uptake.
  • Alignment with pharmaceutical sponsors' priorities provides actionable insights for clinical and commercial success.

Conclusions:

  • Strengthened partnerships between implementation scientists and life science partners, established early, can accelerate the translation of therapies into routine care.
  • Early collaboration improves return on investment and reduces the time to clinical impact.
  • Proactive implementation science integration enhances the likelihood of successful therapy adoption and sustainment.