Clinical outcome assessment (COA) has seen rapid growth in recent years, expanding on both the outcomes that are considered suitable to measure and the gold-standard of statistical evidence required by regulatory bodies to demonstrate that a COA is providing reliable and valid scores for the outcome of interest. This applies equally to all manner of outcomes, including PROs, ClinROs, ObsROs, and others. Vector Psychometric Group (VPG) has been providing high-quality consulting for years, making us uniquely suited to assist you in navigating the complexities at all stages of COA development, validation, and subsequent analyses.
In recent years, health care payers and regulatory organizations have established principles requiring that clinical trials be patient-centered. These principles apply to the COAs that are used in studies as well as the overall design and execution of research. From qualitative work that informs the early stages of COA development to clinical trial exit interviews that reveal how patients view the benefits and drawbacks of a treatment, VPG provides robust, high-quality study designs, executes studies with fidelity and thorough documentation, and reports results in ways that are meaningful for multiple audiences, including patients and regulators. VPG’s capabilities extend to all types of qualitative research used to develop or evaluate patient-centered COAs, including concept elicitation studies, key opinion leader studies, cognitive debriefing interviews, and trial exit interviews.
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Psychometrics broadly refers to an area of study focused on mathematical and statistical models to relate observable data to unobservable constructs; this includes stereotypical “psychological” constructs, such as intelligence and depression, but psychometric techniques may be used to improve the measurement of any unobservable concept, including such varied ideas as satisfaction with a medical product, quality of life, or overall symptom severity. VPG offers a full range of psychometric consulting services from study design consulting services to advanced quantitative analyses, such as factor analysis and item response theory, that supply evidence that your measure is providing reliable scores and valid inferences/uses suitable for informing high-stakes decisions.
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In addition to the specialized psychometric services we supply, VPG offers more general statistical consulting. We are able to provide expert analysis using a wide range of statistical techniques for a large variety of data sources, such as large-scale clinical trial data, small sample data from rare disease populations, and post-market studies.
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In addition to our specialized statistical services for health outcome researchers, VPG also offers:
- Secure, web-based data collection services, including adaptive administration of measures
- General literature reviews
- Reports/dossiers consolidating previous work
- Replication of findings
- Statistical forensics
- 3rd party quality checks of qualitative, psychometric, and behavioral analytic work