PROactive Clinical Insights

Leverage the gold standard in patient-centric insights throughout the product lifecycle

Reliance on patient insights provides increased value for the development of new treatments. Understanding health-related quality of life (HRQoL) and disease burden from the patient's perspective offers treatment development teams as much knowledge about unmet clinical needs as assessing the efficacy of new treatments.

Data derived from real patient experiences using patient-reported outcome (PRO) measures can fill crucial knowledge gaps in clinical research and commercialization. Discover how PROs have become versatile instruments that enhance decision-making throughout the entire clinical trial.

Patient-Reported Outcomes

Health outcomes reported by patients or study subjects themselves without interpretation by clinicians, caregivers or other observers. Data is captured via self-directed, self-completed questionnaires or surveys that are standardized and validated.

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Applying PROs across Clinical Trials

Measures like QualityMetric's SF-36v2® and SF-12v2® health surveys can inform decisions in every phase of research. Make the most of gathered insights with QM survey interpretation and linguistic validation services.

Preclinical

Investigating the application of a new drug
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- Use generic health status PROs to identify unmet clinical need through population-level health surveys using SF-36v2/SF-12v2 and general population norms and disease specific benchmarks
- Unmet clinical needs drive development of new treatments
- ACT – identify uncontrolled disease with current therapies
- HIT-6 – screen for migraine; identify uncontrolled disease with current therapies
- Identification of unmet clinical needs drive
  development of new treatments
Phase I

Determining initial drug safety and dosing
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- Optimal time to develop PRO/COA measurement strategy for clinical trial programs
- Conduct landscape analysis of available PRO/COA instruments available in therapeutic are under study
- Identify gaps in currently available PRO/COA tools as fit-for-purpose endpoints in clinical trials
- Conduct qualitative/quantitative research to produce necessary evidence to address gaps
- Launch new instrument development initiatives when necessary or modify existing instruments using information from qualitative research
- Select endpoints to guide strategic
  data collection
Phase II

Provide treatment benefits and key stakeholders
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- Phase II trials can be used to gather information on the reliability, validity and responsiveness of new PRO/COA tools developed for the trial program
- Phase II trials can be used to gather information on the reliability, validity and responsiveness of existing legacy PRO/COA tools that were not developed specifically for the disease being studied in the trial program
- Phase II trials can be used to establish clinically meaningful thresholds of change in the primary efficacy endpoint using PROs as the criterion measure (how much needs to change on the primary efficacy endpoint that results in a clinically meaningful improvement in patient's functional status and well-being)
- Phase II trials can be used to establish clinically meaningful changes in PROs/COAs for the disease being studied in the trial program
- Phase II trials can be used to explore when it is appropriate to elevate a PRO from exploratory to a secondary efficacy endpoint
- Explore potential treatment efficacy
  and tolerability
Phase III

Comparing drug to existing market options
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- As secondary endpoints, PROs provide important information on the benefits of treatment in terms that matter most to patients
- As exploratory endpoints, PROs can provide important messaging about product benefits that resonate with other stakeholders beyond regulatory, such as payors and consumers
- As an endpoint, PROs can provide important messaging about product benefits in peer reviewed publications, poster and abstracts presented at professional conferences, that assist brand teams positioning of products
- As an endpoint, PROs can provide important messaging about patient benefits that can be incorporated in product labels
- As an exploratory endpoint, PROs can be used to provide evidence to support claims on benefits of treatment observed with primary and secondary efficacy endpoints
- Provide evidence and support compliance
  including, label and marketing claims
Phase IV

Monitoring drug for long-term performance
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- Use to build real world evidence to support product label claims
- Contribute to comparative effectiveness research
- Examine patient treatment
  experiences over time
Post-Launch

Marketing drug to stakeholders and users
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- PROs can be used to build brand awareness about treatment benefits beyond clinical outcomes and in terms that matter most to patients/consumers
- Deploy PROs to craft product messaging with real patient experience and analytics
- Develop strong patient-centric
  product messaging

Why Capture Patient Perspectives

QualityMetric's patient-reported outcome (PRO) measures and clinical outcome assessment (COA) services can provide the answers you need to take your product from innovative idea to powerful solution at every phase of your clinical trial. Reach out to us today to learn more about PRO health surveys for your next clinical trial.

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PROactive Clinical Insights

Leverage the gold standard in patient-centric insights throughout the product lifecycle

Patient-Reported Outcomes

Applying PROs across Clinical Trials

Preclinical

Phase I

Phase II

Phase III

Phase IV

Post-Launch

Why Capture Patient Perspectives