Recognizing that Evidence is Made, not Born.

Area of Science:

• Pharmaceutical Sciences
• Health Services Research
• Regulatory Science

Background:

• Therapeutic product development faces challenges like high attrition rates and regulatory hurdles.
• Gaps exist between stakeholder evidence requirements and supplied evidence, impacting patient access.
• Current processes may contain avoidable inefficiencies due to evidentiary deficiencies or human factors.

Purpose of the Study:

• To propose a novel framework, Structured Evidence Planning, Production, and Evaluation (SEPPE), for therapeutic product development.
• To address inefficiencies and improve the quality of evidence supplied for regulatory approval and market access.
• To integrate emerging innovations and foster systemic transformation in evidence generation.

Main Methods:

• SEPPE treats evidence as a manufactured good, emphasizing "built-in quality" through people and processes.
• The framework incorporates proactive, iterative feedback-and-adjust loops with key decision-makers.
• It advocates for a context-adaptable practices framework integrating innovations.

Main Results:

• The SEPPE approach aims to reduce avoidable evidence quality and decision hazards.
• Iterative feedback loops can enhance the quality of evidence for therapeutic products.
• Successful implementation can facilitate the approval of high-quality therapeutic products with evidence of beneficial performance.

Conclusions:

• Systemic transformation and long-term commitment are critical for the success of SEPPE.
• Adopting a manufacturing-like approach to evidence can improve therapeutic product development.
• SEPPE offers a pathway to bridge the gap between evidence requirements and patient access.