Patient Centered Outcomes

In recent times the clinical research community has made significant advancements in survival and physiological related outcomes across a broad spectrum of therapy areas, creating new treatments that further address clinical unmet needs.

However, as we move further into the future and new therapy development, we need to adjust our focus to accommodate a widely underutilized resource – the patient.  The patient is a door way to advancements in drug and device development that until very recently, has only ever been regarded as a “test subject” rather than the expert in their disease.

Patient Centered Outcomes (PCO), focuses on aspects of disease burden which are priorities for the patient, such as symptoms and their impact. At the center of PCO strategy is qualitative research, a scientific methodology which extracts critical insights directly from the patient in real time.  Throughout the entire development lifecycle, qualitative research can enhance and inform your study.

As a suAzio client, you benefit from 20 years of life science consultancy and scientific rigor, combined with a flexible and collaborative approach designed to maximize strategic outcomes, suAzio is a consistent, dependable research partner.

Qualitative Research

“The real key to successful qualitative research is an enthusiastic interest, firstly in people, and secondly in the issues at hand.”

Qualitative Research can facilitate an understanding of the patient journey and new product attributes, it also explores how patients experience their symptoms, how their life is thereby impaired and how satisfied or dissatisfied they are with the current treatments.

suAzio can help you discover more in the following stages of development.

  • Conceptual Disease Model
  • Target Product Profile
  • Identification of Clinical Outcome Assessments Concepts of Interest (COI)
  • Clinical trial Exit Interviews

Conceptual Disease Models

The conceptual model of a disease summarizes the key concepts of the disease experience. It is useful for developing strategies and to measure meaningful treatment outcomes.

For an optimal clinical trial design, identification and description of “qualitative” associations between disease attributes, progression and outcomes is critical.

Qualitative Research Optimizes

  • Measurement strategy
  • Endpoint models
  • Study design

Target Product Profiles

TPP is a clinical development program summary in the context of labeling goals where specific types of evidence (e.g., clinical trials or other sources of data) are linked to the targeted labeling claims or concepts.

TPP is developed in the early stage of drug development and documents potential treatment benefits. Treatment benefit is demonstrated by evidence that a treatment has a positive impact on how long a patient lives and how a patient feels or functions in daily life.

Qualitative Research Optimizes

  • Treatment benefits
  • TPP objectives
  • Product claim & label strategy

Identification of Clinical Outcome Assessments Concepts of Interest (COI)

A conclusion of treatment benefit is described in labeling in terms of the concept of interest i.e., what is being measured by the assessment (e.g., pain intensity). It is crucial to early identify the specific measurement goal (i.e., the thing that is to be measured by a COA instrument).

Qualitative Research Optimizes

  • Multi-dimensional insights
  • Identification of symptom patterns
  • Symptom impact on patients’ lives

Clinical Trial Exit Interviews

Qualitative data collection from clinical trial participants provides the opportunity to further explore the impact of drug treatment.

Qualitative Research Optimizes

  • The evaluation or “ideal” treatment attributes
  • Key factors driving treatment satisfaction and adherence
  • Patient treatment evaluation
  • Reasons for study withdrawal

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Insights

Want further insight? Our blog often discusses today’s relevant topics and provides food for thought when considering various types of challenges any study can encounter, based on our vast experience.

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