Foundational Papers: Strengthening Clinical Research Proposals Through Pre-Grant Evidence Building

The increasing competitiveness of clinical research funding necessitates well-supported grant proposals with preliminary evidence. Traditionally, researchers have relied on pilot studies or retrospective analyses, which require institutional review board (IRB) approval, funding, and extensive time - factors that can hinder timely grant submissions. This paper introduces the concept of foundational papers, an alternative pre-grant strategy that leverages publicly available data, theoretical frameworks, and computational methodologies to strengthen research proposals. We categorize foundational papers into four types: (1) Conceptual and Theoretical Justification Papers, which establish intellectual foundations and clarify knowledge gaps; (2) Computational and Trial Simulation Papers, which employ synthetic data, Monte Carlo simulations, and agent-based modeling to assess study feasibility; (3) Data-Driven Justification Papers, which utilize open-access datasets to generate preliminary epidemiological and statistical insights; and (4) Researcher and Patient Partner Engagement Papers, which incorporate stakeholder perspectives through indirect methodologies without IRB constraints. By transforming key grant proposal components into peer-reviewed publications, foundational papers enhance proposal quality, increase funding success rates, and ensure that research efforts contribute to the broader scientific community - even if a grant remains unfunded. This approach mitigates inefficiencies in academic research, fosters collaboration, and strengthens the translation of research ideas into actionable scientific contributions. Foundational papers serve as a sustainable bridge between funding cycles, safeguarding knowledge and maximizing scientific impact.