Outcomes Research

Evidera scientists are leading single-sponsor and consortium efforts to develop patient-reported outcome (PRO) instruments for use in clinical trials, including the first EMA and FDA-qualified PRO measure, the EXACT. Read More

Services & Products

  • Publications

    Publication

    Beyond Study Participants: a Framework for Engaging Patients in the Selection or Development of Clinical Outcome Assessments for Evaluating the Benefits of Treatment in Medical Product Development. Qual Life Res. 2017 Apr 19. [Epub ahead of print] ABSTRACT

    Publication

    Health State Utilities Associated with Glucose Monitoring Devices. Value Health. 2017 Mar;20(3):507-511. doi: 10.1016/j.jval.2016.10.007. Epub 2016 Dec 22. ABSTRACT

    Publication

    Baseline Severity as Predictor of Change in St George’s Respiratory Questionnaire Scores in Trials of Long-Acting Bronchodilators with COPD Patients. Chronic Obstr Pulm Dis (Miami). 2017; 4(2): 132-140. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0129. ABSTRACT
    See More
  • Webinars

    Webinar

    Quantitative Benefit-Risk Assessment in Drug Development

    Presenters: Tommi Tervonen, PhD, Research Scientist, Outcomes Research, Evidera; Kevin Marsh, PhD, Senior Research Scientist and Executive Director, OR, Evidera

    Additional Info
    Contact us for slides

    Webinar

    Medication Adherence and Outcomes Research: 21st Century Insights

    Presenters: Colleen A. McHorney, PhD, Senior Research Leader, Outcomes Research, Evidera

    Additional Info
    Contact us for slides

    Webinar

    How are Patient Preferences Used to Support Decisions? Examples from Industry

    Presenters: Heather Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera; Jiat-Ling Poon, PhD, Senior Research Associate, Outcomes Research, Evidera; Sumitra Sri Bhashyam, PhD, Research Associate III, Modeling & Simulation, Evidera

    THIRD OF 3-PART SERIES ON PATIENT PREFERENCE

    Additional Info
    Contact us for slides
    See More
  • White Papers

    Whitepaper

    Clinical Outcomes Assessments: Unique Considerations in Pediatric Rare Diseases

    Authors: Dawn Phillips, PT, MS, PhD, Research Scientist, Outcomes Research; Robin Pokrzywinski, PhD, MHA, Research Scientist, Outcomes Research, Evidera

    Year: 2017

    View

    Whitepaper

    Advantages and Disadvantages of Using Phase III Clinical Trials for Psychometric Evaluation of New PROs

    Authors: Dennis A. Revicki, PhD, Senior Vice President, Outcomes Research, Evidera

    Year: 2017

    View

    Whitepaper

    Optimizing Trial Design: Incorporating MCDA into Trial Simulation

    Authors: Kevin Marsh, PhD, Senior Research Scientist and Executive Director, Outcomes Research, Evidera; Oscar Della Pasqua, MD, PhD, Chair of Clinical Pharmacology and Therapeutics, University College London, Natalia Hawken, PhD, Research Associate, Outcomes Research, Evidera

    Year: 2017

    View
    See More
  • Presentations

    Oral Presentation

    Determination of Minimal Important Difference Thresholds for Parkinson’s Disease Questionnaire-39 in Advanced Parkinson’s Disease Patients

    XXI World Congress on Parkinson’s Disease and Related Disorders:

    Milan, Italy
    06-Dec-2015

    Authors/Presenters: Antonini A, Bacci ED, Sail K, Jalundhwala YJ, Kandukuri PL, Marshall T, Chatamra K, Wiklund I, Revicki D

    Year: 2015

    Poster

    Challenges and Opportunities for PROs and Big Data: Applications for the Pharmaceutical Industry

    ISOQOL 22nd Annual Conference – 2015:

    Vancouver, BC, Canada
    21-Oct-2015

    Authors/Presenters: Lenderking WR

    Year: 2015

    Poster

    What Type of Response Scale is the Most Responsive? A Comprehensive Review of Response Scale Options for Patient-reported Outcome Measures

    ISPOR 20th Annual International Meeting – 2015:

    Philadelphia, PA, USA
    16-May-2015

    Authors/Presenters: Rudell K, Vernon MK, Gries K, Safikhani S, DeLozier A, McQuarrie K, Norquist J, Coons SJ

    Year: 2015

    See More
  • Fact Sheets

    Fact Sheet

    Outcomes Research
    Download

    Fact Sheet

    Patient-Centered Outcomes Research at Evidera
    Download

    Fact Sheet

    Pharmaceutical Products Approved by FDA with PRO Label Information; Updated Through Q2 2017
    Download

    Fact Sheet

    Pharmaceutical Products Authorised by EMA with PRO Label Information; Updated Through Q2 2017
    Download

Evidera’s outcomes researchers represent a unique combination of scientific disciplines, including psychometrics, epidemiology, biostatistics, psychology and public health. We develop and evaluate clinical outcome assessments to support labeling and promotional claims. We are your partner for evaluating patient, clinician, caregiver and performance outcomes, utilities and preferences, adherence and other customized prospective observational study needs.

Evidera designs and implements strategies for outcome evaluation, including clinician-reported outcomes (ClinRO), patient-reported outcomes (PRO), observer/caregiver-reported outcomes (ObsRO) and/or performance outcomes/tests (PerfO) that meet regulatory and stakeholder demands. We take an evidence-based approach to instrument development, driven by extensive experience measuring health outcomes across a variety of conditions and diseases. We help you understand the issues and design your program from concept identification and development through platform selection, instrument design and psychometric testing, and we provide ongoing support during implementation and analyses.

With Evidera as your partner, you get a team of leading scientists who have developed innovative methods and instruments that are rapidly adopted by the field. For example, Evidera:

  • Created one of the few PRO instruments recommended for clinical use in an international clinical guidance document: COPD Assessment Test (CAT)
  • Developed the first multisponsor PRO consortium: The EXACT-PRO Initiative
  • Developed the first PRO instrument to achieve FDA PRO qualification: The EXACT
  • Designed two of the first condition-specific utility indexes: asthma symptom utility index (ASU) and rhinitis symptom utility index (RSUI)
  • Partnered with the American Neurogastroenterology and Motility Society (ANMS) to develop the ANMS gastroparesis cardinal symptom daily diary, now an endpoint for clinical trials in diabetic and idiopathic gastroparesis

Offerings

Instrument Development and Psychometric Evaluation

Develop strategies to enhance ClinRO, PRO, ObsRO and PerfO from concept identification through psychometric evaluation and dissemination.

Outcomes Strategy

Discuss the strengths and limitations of your product or portfolio, identify outcomes with measurable value, establish research goals, prepare a plan for goal achievement and guide the plan to a successful conclusion. Develop focused and customizable training programs, which can be a valuable component in achieving these goals.

Outcomes Evidence Dossier

Enhance your regulatory positioning with a carefully compiled dossier of evidence delineating the precision of your product’s key outcome measures.

Health Utilities Studies

Obtain health state utility valuations (time trade-off and standard gamble), consultation on inputs for cost-utility modeling, the development of condition-specific preference-based measures, and mapping to generic preference-based measures.

Clinical Trials Support

Support trial design, Clinical Outcomes Assessment (COA) strategies, patient engagement, statistical analysis plans, results interpretation and reports.

Electronic Clinical Outcomes Assessment (eCOA)

Evaluate mode selection and conduct cognitive interview/usability and equivalence studies for electronic instrument development.

Advanced Psychometric and Statistical Modeling Services

Conduct in-depth statistical analyses, including Rasch and item response theory (IRT) methods and advanced psychometric methods as well as advanced statistical modeling such as latent growth curve analysis, mixture models and structural equation models.

Regulatory Support

Inform your outcomes research strategy from trial design to communication with regulatory agencies.

Scientific Dissemination

Plan and execute outcomes research dissemination strategies from inception to completion.

Outcomes Research Experts

Services & Products

  • Publications

    Publication

    Beyond Study Participants: a Framework for Engaging Patients in the Selection or Development of Clinical Outcome Assessments for Evaluating the Benefits of Treatment in Medical Product Development. Qual Life Res. 2017 Apr 19. [Epub ahead of print] ABSTRACT

    Publication

    Health State Utilities Associated with Glucose Monitoring Devices. Value Health. 2017 Mar;20(3):507-511. doi: 10.1016/j.jval.2016.10.007. Epub 2016 Dec 22. ABSTRACT

    Publication

    Baseline Severity as Predictor of Change in St George’s Respiratory Questionnaire Scores in Trials of Long-Acting Bronchodilators with COPD Patients. Chronic Obstr Pulm Dis (Miami). 2017; 4(2): 132-140. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0129. ABSTRACT
    See More
  • Webinars

    Webinar

    Quantitative Benefit-Risk Assessment in Drug Development

    Presenters: Tommi Tervonen, PhD, Research Scientist, Outcomes Research, Evidera; Kevin Marsh, PhD, Senior Research Scientist and Executive Director, OR, Evidera

    Additional Info
    Contact us for slides

    Webinar

    Medication Adherence and Outcomes Research: 21st Century Insights

    Presenters: Colleen A. McHorney, PhD, Senior Research Leader, Outcomes Research, Evidera

    Additional Info
    Contact us for slides

    Webinar

    How are Patient Preferences Used to Support Decisions? Examples from Industry

    Presenters: Heather Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera; Jiat-Ling Poon, PhD, Senior Research Associate, Outcomes Research, Evidera; Sumitra Sri Bhashyam, PhD, Research Associate III, Modeling & Simulation, Evidera

    THIRD OF 3-PART SERIES ON PATIENT PREFERENCE

    Additional Info
    Contact us for slides
    See More
  • White Papers

    Whitepaper

    Clinical Outcomes Assessments: Unique Considerations in Pediatric Rare Diseases

    Authors: Dawn Phillips, PT, MS, PhD, Research Scientist, Outcomes Research; Robin Pokrzywinski, PhD, MHA, Research Scientist, Outcomes Research, Evidera

    Year: 2017

    View

    Whitepaper

    Advantages and Disadvantages of Using Phase III Clinical Trials for Psychometric Evaluation of New PROs

    Authors: Dennis A. Revicki, PhD, Senior Vice President, Outcomes Research, Evidera

    Year: 2017

    View

    Whitepaper

    Optimizing Trial Design: Incorporating MCDA into Trial Simulation

    Authors: Kevin Marsh, PhD, Senior Research Scientist and Executive Director, Outcomes Research, Evidera; Oscar Della Pasqua, MD, PhD, Chair of Clinical Pharmacology and Therapeutics, University College London, Natalia Hawken, PhD, Research Associate, Outcomes Research, Evidera

    Year: 2017

    View
    See More
  • Presentations

    Oral Presentation

    Determination of Minimal Important Difference Thresholds for Parkinson’s Disease Questionnaire-39 in Advanced Parkinson’s Disease Patients

    XXI World Congress on Parkinson’s Disease and Related Disorders:

    Milan, Italy
    06-Dec-2015

    Authors/Presenters: Antonini A, Bacci ED, Sail K, Jalundhwala YJ, Kandukuri PL, Marshall T, Chatamra K, Wiklund I, Revicki D

    Year: 2015

    Poster

    Challenges and Opportunities for PROs and Big Data: Applications for the Pharmaceutical Industry

    ISOQOL 22nd Annual Conference – 2015:

    Vancouver, BC, Canada
    21-Oct-2015

    Authors/Presenters: Lenderking WR

    Year: 2015

    Poster

    What Type of Response Scale is the Most Responsive? A Comprehensive Review of Response Scale Options for Patient-reported Outcome Measures

    ISPOR 20th Annual International Meeting – 2015:

    Philadelphia, PA, USA
    16-May-2015

    Authors/Presenters: Rudell K, Vernon MK, Gries K, Safikhani S, DeLozier A, McQuarrie K, Norquist J, Coons SJ

    Year: 2015

    See More
  • Fact Sheets

    Fact Sheet

    Outcomes Research
    Download

    Fact Sheet

    Patient-Centered Outcomes Research at Evidera
    Download

    Fact Sheet

    Pharmaceutical Products Approved by FDA with PRO Label Information; Updated Through Q2 2017
    Download

    Fact Sheet

    Pharmaceutical Products Authorised by EMA with PRO Label Information; Updated Through Q2 2017
    Download
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