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EXPLORING PATIENT CONCEPTS TO OPTIMISE TRIAL ENDPOINTS 

Researching the landscape and capturing the patient voice early in clinical development.

About

ABOUT

Creating meaningful outcomes 

Concept COA was developed to be an evidence planning partner navigating patient experience data in early clinical development. We explore multi-dimensional insights to better understand concepts of interest (COI) most meaningful to patients, to enable you to design comprehensive pivotal trials.

 

  As regulatory bodies promote inclusion of clinical outcome assessment (COA) that rigorously measure adjustments in COI(s) in overall evidence claims, it is easy to assume that novel COA development is required. Instead, there is stated preference towards utilising and modifying existing fit-for-purpose COAs, which promotes the necessity to understand COI(s) together with the existing COA landscape for the target patient population as early as feasibly possible.

Our solutions are designed specifically with regulatory guidance in mind. Effectively leveraging existing patient experience data sources to lay the conceptual foundations of your COA measurement strategy.

Services

SERVICES

Image by Cristina Gottardi

LITERATURE AND MEASUREMENT 

REVIEW

Explore the existing evidence 

A well designed literature review explores health concepts with the most meaningfulness to patients, and identifies existing COA's used to measure treatment benefits and risks in the intended patient population. 

Business Plan

CONCEPTUAL

ANALYSIS

Measuring what is important to patients

A conceptual disease model visually represents patient experiences of their condition's symptoms and quality of life impacts. It identifies the most meaningful COI(s) to targert and is the foundation of measurement analysis and successful COA strategy.

Image by Emily Morter

EVIDENCE REVIEW AND

GAP ANALYSIS

A detailed evaluation of existing patient experience data and COA properties indicates the next steps in building a comprehensive COA strategy.

Is there already a fit-for-purpose COA?

Are more interviews with patients needed?

Can an existing COA be modified?

What psychometric evidence is missing? 

Is it fit-for-purpose?

"...before deciding on a COA for potential inclusion in a clinical trial, it is important to ensure the foundational work is done to understand the patients' experiences and to identify a concept of interest (COI) that is both important to patients and is likely to be effected by the medical product under study in the trial" -  Centre for Drug Evaluation and Research, FDA

“One unintended consequence of the 2009 PRO guidance was that many sponsors assumed they had to create new PROs. The guidance is not just about developing new COAs. Rather, we’re trying to dissuade people from developing new COAs if there are good existing measures.” – Centre for Drug Evaluation and Research, FDA

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