Thought Leadership

ICPE 2024

Using QBA in the selection of
computable operational definitions to minimize misclassification and underpower in RWE studies

August 2024

Our CEO Aaron Kamauu presented at the recent ICPE 2024 conference in Berlin on how CODefs can influence and address challenges with misclassification and underpower in RWE Studies.

Presented at the ICPE 2024. 24-28 August 2024, Berlin, Germany.

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
Guidance for Industry

July 2024

Here at Navidence, the concept of Computable Operational Definitions (CODefs) are intrinsically driven by demands from regulators.

In this guidance the FDA outline how CODefs can impact several key areas:

1) Expectations around what a Computable Phenotype (aka CODef) should be comprised of.

2) How to provide these to the FDA as part of your protocol and study report.

3) The application of CODefs to help Patient Selection in studies.

4)  The application of CODefs in assessment to assess EHR or clinical data repositories. 

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.

Guidance for Industry

December 2023

Here at Navidence, the concept of Computable Operational Definitions (CODefs) are intrinsically driven by demands from regulators. In this guidance the FDA refer to the use of Operational Definitions that include 3 key components:

1) Time frame over which assessment occurs.

2) Specific codes/component(s) assessed (e.g., via code lists).

3) Algorithm for combining the components (leading to positive identification or lack identification).

These are the fundamentals characteristics of CODefs.

"Computable Phenotypes" - Understanding Their Importance in Regulatory Submissions of RWE.

Our CEO Aaron Kamauu, spoke at ISPOR 2024 alongside Marie Bradley from the FDA and Scott DuVall from US Department for Veterans Affairs, to showcase how the Power of CODefs can be used to illustrate fit-for-purpose use of real world data sources to regulators.

Presented at ISPOR Annual Meeting, Atlanta. 4th-8th May 2024.

Objective Fit-4-Purpose Assessment of Real-World Data for Evidence Generation in Type 2
Diabetes Mellitus: A Trial Tokenization Approach

The Navidence Team working alongside our colleagues from Datavant showed how the use of CODefs can derive significant value in the assessment of the value of RWD Tokenisation, as well and providing robust evidence of quality and fit-for-purpose to regulatory agencies.

Presented at ISPOR Annual Meeting, Atlanta. 4th-8th May 2024.

Development of a Comprehensive List of Immunosuppresive Therapies to Enable a Multi-Data Source Globel Real World Effectiveness Program of Immunocompromised Patients

The Navidence Team working alongside a team from AstraZeneca, University of Utah School of Medicine, Veterans Association-Informatics and Computing, UPMC-University of Pittsburgh, to define and develop a comprehensive list of immunosuppressive medications in order to underpin CODef library development for further RWE Research use cases.

Presented at the ISPOR Europe, 2023. 12-15 Novemeber 2023, Copenhagen Denmark.

Development of Computable Operational Definitions to Maximize Comparability & Consistency Across a Multi-Data Source Global Real-World Effectiveness Program

The Navidence Team working alongside a team from AstraZeneca to develop source-agnostic Computable Operational Definitions (CODef) to support a multinational, multi-data source real-world effectiveness program.

Presented at the 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) | August 23–27, 2023, Halifax, Nova Scotia, Canada

SCOPE 2023

Clear, Consistent, and Computable Operational Definitions: Defining the Purpose and Data Needs for Real-World Evidence Generation

Our CEO, Aaron Kamauu presented at the recent SCOPE Summit 2023 discussing the regulatory drivers from the FDA and the benefits of utilizing Computable Operational Definitions (CODEF) to enable RWE Design in the Age of Data.