- Targeted Literature Reviews
- Mapping the natural history of the disease or condition and unmet needs.
- Social Media Listening & Patient Interviews
- Gathering direct patient and caregiver perspectives.
- Epidemiological & Demographic Analysis
- Identifying and segmenting specific patient subpopulations.
- Landscape Assessment
- Evaluating the broader healthcare environment.
- Stakeholder Engagement
- Facilitating expert input directly from healthcare providers, payers and regulators.
Clinical Outcome Assessment strategy
Evidence-Based COA Strategy forPatient-Focused Drug Development
Get startedWho we are
About
Welcome to our COA Strategy Consulting team, where we specialise in enhancing patient-centred endpoints in early clinical development.
Fourth Wall Research works to current FDA PFDD standards as a matter of course. Our methods are aligned with ISPOR good practices for outcomes research and the FDA-NIH fit-for-purpose evidentiary framework. We monitor the regulatory landscape continuously, so your programme is positioned for the standards that will apply at submission, not those that applied when development began.
The name Fourth Wall Research stems from “breaking the fourth wall” between audience and storyteller. The barrier between manufacturer and the patient’s experience in their own words requires a skilled approach, balancing both patient and clinical benefit.
A connected evidence journey
Services
From understanding the disease or condition to identifying fit-for-purpose clinical outcome assessments (COAs), Fourth Wall Research is your partner of choice for deep domain expertise, built for early-development evidence generation.
Engage us for the full pathway or any single stage.
Understanding the Disease or Condition
The objective is to identify the meaningful aspects of health (MAH) that are most important to patients and relevant to your specific subpopulations.
5 capabilities
Understanding the Disease or Condition
The objective is to identify the meaningful aspects of health (MAH) that are most important to patients and relevant to your specific subpopulations.
Conceptualising Clinical Benefits & Risk
Defining the concepts of interest (COIs) that represent the meaningful aspects of health (MAH) your medical product intends to improve.
5 capabilities
Conceptualising Clinical Benefits & Risk
Defining the concepts of interest (COIs) that represent the meaningful aspects of health (MAH) your medical product intends to improve.
- Conceptual Disease Modelling
- Mapping out both proximate and distal MAH.
- Concept Elicitation Interviews
- Exploring lived experiences with patients, caregivers and clinical experts.
- Clinical Benefit Mapping
- Identifying and defining the MAH that the medical product is intended to improve.
- COI Strategy
- Identifying and defining the precise COIs to be measured that assess the MAH.
- Protocol Alignment
- Defining the exact context of use (COU) for the clinical trial.
Selecting / Developing the Outcome Measure
Whether identifying an existing measure, modifying one, or developing a new tool entirely, the goal is to secure a highly valid measurement strategy.
5 capabilities
Selecting / Developing the Outcome Measure
Whether identifying an existing measure, modifying one, or developing a new tool entirely, the goal is to secure a highly valid measurement strategy.
- Modality Selection
- Selecting the most appropriate clinical outcome assessment (COA) types, including patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome (ClinRO) or performance outcome (PerfO) measures.
- Instrument Gap Analysis
- Conducting systematic searches for existing COAs measuring the concept of interest (COI) in the context of use (COU).
- COA Modification & Adaptation
- Collecting evidence and modifying an existing COA where one exists for the COI but requires adjustment for the targeted COU.
- Cognitive Interviews
- Ensuring the target patient population understands the measure's instructions, questions and response options exactly as the developers intended.
- De Novo Instrument Development
- Developing a new COA and evaluating it empirically when no suitable COA exists for the COI and COU.
Fit-for-Purpose Clinical Outcome Assessment (COA) Instrument
The final outcome is a fully justified, regulatory-ready endpoint strategy.
3 capabilities
Fit-for-Purpose Clinical Outcome Assessment (COA) Instrument
The final outcome is a fully justified, regulatory-ready endpoint strategy.
- Regulatory Documentation
- Finalising dossiers in which the context of use (COU) and concept of interest (COI) are clearly defined.
- Scientific Rationale Generation
- Establishing a clear rationale that connects the selected measure to the desired clinical endpoints.
- Evidentiary Dossier Compilation
- Gathering and structuring sufficient evidence to justify the rationale for regulatory submission.
What our clients say
Client testimonials
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Discover how we can help you.
Talk to us about building a patient-centred, regulatory-ready COA strategy for your programme.