Early dialogue

Definition and Description of the Concept "Early Dialogue" in Health Technology Development

Early Dialogue (ED) is a structured, systematic process of interaction between health technology developers (e.g., manufacturers of drugs, medical devices, diagnostics) and Health Technology Assessment (HTA) bodies and/or regulatory agencies at an early stage of product development. The primary purpose of Early Dialogue is to provide non-binding, collaborative advice on evidence generation plans, clinical development strategies, and data requirements that will support future HTA assessments, reimbursement decisions, and regulatory approvals.

Key Characteristics of Early Dialogue

- Timing: Occurs early in the development lifecycle, often before pivotal clinical trials or major regulatory submissions, enabling manufacturers to plan effectively and align their development with healthcare system needs.  

- Participants: Involves HTA agencies, regulatory bodies, manufacturers, and sometimes other stakeholders such as clinicians or patient representatives.  

- Scope: Covers clinical trial design, comparator choice, relevant endpoints, economic evaluations, and organizational or social aspects relevant to the technology’s adoption.  

- Outcome: Provides guidance to optimize evidence generation to meet the expectations of payers and regulators, reducing uncertainty and improving the likelihood of successful market access.  

- Non-binding: The advice given is not legally binding but highly influential for development strategies.

Importance and Benefits

- Helps innovators ensure that their health technologies demonstrate added value compared to existing alternatives.  

- Facilitates alignment between regulatory requirements and HTA/payer expectations, addressing a common gap where regulatory approval does not guarantee reimbursement.  

- Supports faster, more efficient translation of innovations into healthcare systems by anticipating evidence needs.  

- Encourages multi-stakeholder collaboration early in the process, improving transparency and trust.

Relation to Other Concepts

- Early Dialogue is closely related to **Early Advice** and **Scientific Advice**, which are sometimes used interchangeably but may differ slightly in formality or scope depending on the agency or context.  

- It is part of a continuum of early engagement activities aimed at improving evidence generation and decision-making in health technology development.

Summary

This comprehensive definition and description of **Early Dialogue** reflect current understanding and practices in health technology assessment and regulatory science.

Reference

[1] A systematic review of the early dialogue frameworks used within ... https://pubmed.ncbi.nlm.nih.gov/36276363/

[2] Health Technology Assessment - MedTech Europe https://www.medtecheurope.org/access-to-medical-technology/health-technology-assessment/

[3] A systematic review of the early dialogue frameworks used within ... https://pmc.ncbi.nlm.nih.gov/articles/PMC9583828/

[4] Regulatory and HTA early dialogues in medical devices https://www.sciencedirect.com/science/article/pii/S0168851021001937

[5] [PDF] Boosting cooperation on health technology assessment https://www.europarl.europa.eu/RegData/etudes/BRIE/2018/614772/EPRS_BRI(2018)614772_EN.pdf

[6] Early Health Technology Assessment Advice: Opportunities ... - ISPOR https://www.ispor.org/publications/journals/value-outcomes-spotlight/vos-archives/issue/view/unlocking-the-promise-of-real-world-evidence/early-health-technology-assessment-advice-opportunities-to-achieve-collaborative-and-efficient-dialogue

[8] Early Health Technology Assessment | Early HTA Engagement https://www.certara.com/early-hta-engagement/