# Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development Decisions

## TL;DR

This paper argues for using real-world evidence to improve clinical development decisions and outlines a strategy for generating this evidence systematically.

## Contribution

The paper provides a phased blueprint for designing real-world studies aligned with clinical development.

## Key findings

- Relying on expert opinion or historical patterns leads to suboptimal trial design and uninterpretable findings.
- Integrated real-world evidence generation can improve decision-making for sponsors, regulators, and payers.
- A phased approach to RWE generation is proposed to align with clinical development timelines.

## Abstract

Clinical development delays and failures do not serve public health. Reliance solely on expert opinion or historical patterns rather than evidence from representative, real-world point-of-care data about the indication results in suboptimal trial design, missed opportunities, and uninterpretable findings. Investment in real-world evidence (RWE) generation to build a deep, comprehensive, and current understanding of the characteristics, care, and outcomes of the indicated population is essential to improving clinical development decision making. Despite the recognized value of RWE, this evidence generation is not done systematically. Here we make integrated RWE generation more compelling and practicable by addressing concerns we have heard from biopharma leaders and, for emerging RWE leaders, providing a blueprint for designing real-world studies in a phased approach that aligns with clinical development investment. Our work is intended to facilitate more widespread adoption of integrated RWE generation, beginning early in development, so that robust RWE is in hand at the right time for evidence-based decision making by the sponsor, regulators, and payers.

The online version contains supplementary material available at 10.1007/s43441-025-00822-x.