Measuring Treatment Efficacy and Supporting Product Claims in Clinical Trials; Disease Screening and Raising Clinician and
Consumer Awareness in Direct-to-Consumer Marketing
Outcomes Insight™ Consulting supports PRO-related efforts to:
- Develop new or refine existing PRO surveys
- Design clinical trials, data collection protocols, and analytic plans
- Track and monitor the quality of PRO data
- Interpret treatment effects against published and proprietary benchmarking databases
- Track published references regarding the SF tools in key therapeutic areas
- Provide post-hoc analysis of completed trials to optimize strategies for future efforts
- Prepare abstracts, presentations, and manuscripts reporting results for publication in leading peer-reviewed journals and/or
presentation to internal and external stakeholders
For customers in pursuit of product insert and labeling claims, we offer PRO Path™ Strategic Services, a sequence of
PRO-related services geared to deliver a rigorous plan of action to substantiate PRO claims.
PRO Path consists of six stages, each with defined value and deliverables from needs assessment to peer-review dissemination.
QualityMetric's PRO Path – a sequence of strategic PRO services offered by our Outcomes Insight
Consulting Division to support pharmaceutical, biotechnology, and medical device clients in their pursuit of product insert and labeling claims.
| Stage of Planning |
Customer Needs |
QualityMetric Services and Deliverables |
Stage 1
|
To understand Burden of Disease and what aspects of functioning and well-being are most important to patients |
PRO Path Needs Assessment Report:
Burden of disease report combining qualitative/quantitative analysis integrated with comprehensive literature review |
Stage 2
|
A comprehensive strategy built on information compiled in PRO Needs Assessment |
PRO Path Strategy Report:
Recommendations document for choice of PRO measurement surveys |
Stage 3
|
Evidence of psychometric properties of PRO tools |
PRO Path Validation Report:
Summarize reliability, validity and other properties of PRO measures fielded |
Stage 4
|
Confidence that PRO measures will be incorporated in trial design to maximize ability to characterize and quantify treatment effects |
PRO Path Administration and Analysis Plan:
Content for protocol to specify all aspects of PRO survey administration and data analysis |
Stage 5
|
A comprehensive strategy built on information compiled in PRO Needs Assessment |
PRO Path Efficacy Technical Report:
Summary of treatment effects on PRO endpoints |
Stage 6
|
A comprehensive strategy built on information compiled in PRO Needs Assessment |
PRO Path Peer-review Dissemination Plan:
Manuscripts, abstracts, posters, podium presentations and expert testimony |
To obtain further information, please contact Jim Vermilyea at 781 890-8882, x335
Products & Services
|
Related Information
|
