Accelerating Digital Endpoint Development Through Pre-Competitive Collaboration

DECODE, the Digital Endpoint Collaboration for Outcomes DEvelopment, is Ametris’ pre-competitive collaboration framework designed to help address shared clinical measurement challenges across the life sciences industry. In regulatory contexts where evidence expectations are high, digital measures must be meaningful to patients, scientifically valid, operationally feasible, and aligned with regulatory expectations. By supporting the development and validation of fit-for-purpose, patient-centered digital measures, DECODE helps transform real-world data into validated clinical evidence across clinical research programs.

Building the Evidence Needed for Regulatory-Ready Digital Measures

The use of digital health technologies continues to grow across clinical development, yet certain measurement challenges remain difficult for individual organizations to solve alone. Novel digital endpoints often require extensive evidence to demonstrate that the measure is meaningful, reliable, sensitive to change, and appropriate for a specific context of use.

For sponsors, building this evidence independently can be costly, time-consuming, and risky. DECODE creates a structured path for cross-industry collaboration, helping partners address common evidence gaps, align on methodology, and generate the scientific foundation needed to support broader adoption of digital measures.

A Collaborative Framework for Shared Measurement Challenges

DECODE projects are designed around digital measurement challenges that require industry alignment, scientific rigor, and regulatory engagement. Each project follows a collaborative framework that brings key stakeholders together to define the problem, build consensus, generate evidence, and operationalize a digital measure for use across drug development programs.

Identify the Measurement Challenge

Each DECODE initiative begins with a shared problem in a specific disease area or clinical context, where existing measurement approaches may not fully capture meaningful aspects of patient experience, function, or treatment response.

Build the Consortium

Ametris brings together pharma sponsors and other partners in a pre-competitive working group to pool expertise, align priorities, and jointly support research and development efforts.

Engage Key Stakeholders

DECODE projects are designed to incorporate input from regulators, clinicians, patients, technology experts, and scientific leaders to ensure that the resulting measure is meaningful, practical, and aligned with evolving expectations.

Generate the Evidence

Project workstreams are structured to address critical evidence needs, which may include usability, meaningfulness, analytical validation, sensitivity to change, and implementation considerations.

Deliver an Operationalized Digital Measure

The outcome of each DECODE project is a new measure or solution designed to address the shared measurement challenge, supported by an evidence dossier and practical implementation resources.

Why Participate in DECODE?

DECODE gives partners the opportunity to help shape emerging digital measures while reducing the burden of developing and validating new endpoints independently.

Shared Investment

Partners pool resources to address evidence gaps that may be too costly or complex for a single organization to solve alone.

Collaborative Development

Workstreams are co-designed with members of the working group, and project deliverables are shared across participating partners.

Regulatory Alignment

Regulators and other key stakeholders are engaged early to support alignment around methodology, evidence expectations, and context of use.

First Access to Deliverables

DECODE partners gain exclusive access to final project deliverables, giving them a head start in evaluating and implementing new tools within clinical development programs.

Greater Industry Impact

By addressing shared measurement challenges through a pre-competitive model, DECODE helps build the consensus and evidence needed to support broader adoption of fit-for-purpose digital measures across therapeutic areas.

Turning Shared Measurement Challenges Into Validated Digital Measures

Each DECODE project is designed to deliver more than a concept or exploratory research initiative. The outcome is a fully operationalized digital measure supported by an evidence dossier covering usability, meaningfulness, and analytical validation and regulatory alignment.

For participating partners, this creates a clearer path from shared measurement challenge to practical implementation. DECODE partners gain exclusive access to final project deliverables, giving them a head start in evaluating and implementing new tools within their clinical development programs.