Patient-Centered Outcomes

Transform Patient Insights to Unlock the True Value of Your Medicines

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Patient-Centered Outcomes
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Commercialization
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Clinical & Regulatory
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Real-World Evidence
Patient Strategy & Engagement
Patient Voices Amplify Breakthrough Value

With extensive experience in regulatory interactions from pre-IND to phase 3, Lumanity provides patient-centered endpoints that are crucial for clinical trial approval and product differentiation. Our outcomes research experts specialize in clinical outcomes assessments (COAs) across a wide range of therapeutic areas, with a proven track record of successful submissions to multiple regulatory and HTA bodies, including the FDA, EMA, Health Canada, and PMDA.

Transform your clinical research and elevate the standard of patient care.

Our Offerings

Gain deep insights into patient experiences throughout the clinical trial process to reveal the true burden of disease, understand the patient experience during treatment, and assess the impact of treatment. As a pioneer of including in-trial interview data into FDA submissions, we conduct patient interviews:
At entry before patients receive treatment to characterize the burden of disease, previous treatment experience, expectations following treatment, behavioral strategies for dealing with disease and coping strategies used by patients
Interim during the treatment period to understand what is happening to patients and why they may discontinue treatment
At exit after treatment to evaluate what changes occurred in the patient’s voice independent of standardized assessments, to determine if those changes were meaningful to patients and patient satisfaction with the intervention
Access some of our latest publications in this area
Effectively integrate the patient perspective into clinical development by measuring what truly matters to patients. Our comprehensive approach ensures that your labeling claims are robust and your marketing and diagnostic tools are impactful. We evaluate, develop and modify COAs, including PROs, ClinROs, ObsROs, and PerfOs, to support:
Regulatory labeling claims, ensuring accurate communication of benefits and risks to patients and providers and differentiation for your product
Marketing and promotion, leveraging on-label or “label worthy” data to improve access to your treatment by educating patients and providers
Screening and diagnostic tools, in order to accurately identify populations for treatment and to ensure the right patients are included in clinical trials
Access some of our latest publications in this area
Navigate complex measurement challenges with a team of psychometric scientists that bridges sophisticated methods and practical solutions. We combine deep expertise in measurement theory with real world implementation strategies to create compelling evidence packages that satisfy regulatory requirements. Our team supports all types of COAs through:
Strategic measurement planning, that satisfies both scientific standards and regulatory expectations
Collaborative partnerships, that translate complex psychometric findings into clear, actionable insights for diverse audiences
Access some of our latest publications in this area
Leverage existing clinical trial datasets to conduct exploratory analyses of COA data, informing publications, scientific communications, and broader value evidence strategies. Our post hoc COA analyses provide a deeper view into treatment impact on symptoms, functioning, and health-related quality of life (HRQoL) beyond the trial endpoints. This approach is particularly valuable for:
Publication strategy, generating new, publication-ready evidence from data already collected
Subgroup and responder analyses, identifying which patient populations derive the greatest benefit
Value evidence generation, supplementing HTA submissions and payer dossiers with additional COA-based evidence
Lifecycle and label strategy, surfacing findings that may support label expansion or future study design
Access some of our latest publications in this area
Ensure that PRO data is a key component for evaluating patient-centered benefits in JCAs and in HTA assessments. Clinical effectiveness and safety data included in JCAs should include robust evidence directly from patients. We can help you to:
PRO Strategy, ensure that your PRO strategy is developed early and with consideration to a JCA so that valid, reliable and responsive endpoints are included in clinical trials to document treatment benefit and address outcomes of interest in the JCA Core Outcome Set. Further, ensure that the PROs are integrated into the comparative evidence package
Ensure that your team has partnered with leading experts in the field to best leverage the data, particularly around the meaningfulness of any changes observed, in your JCA dossier to position you for success in your HTA submissions
Find our more about our EU HTA and JCA expertise
Optimize your clinical trial design and increase the chances for labeling success with our consulting services. We offer strategic advice on including COAs and other endpoints to support labeling claims in both the United States and Europe including:
Regulatory knowledge, enhancing trial design with specialized expertise
Endpoint strategy, ensuring COAs and endpoints effectively support labeling claims
Access some of our latest publications in this area
Describe rare or little-known diseases from the patient’s perspective to inform regulatory submissions, clinicians, and payers. Our natural history studies provide a comprehensive view into disease burden, diagnostic journey, and live patient experience of symptoms, impacts, and health-related quality of life (HRQoL). This approach is particularly valuable for:
Rare/orphan diseases, offering a comprehensive step in disease description
Understanding disease burden, providing insights into patient experiences
Access some of our latest publications in this area
Select the most appropriate COAs for your clinical trials to enhance the likelihood of detecting treatment effects and substantiating labeling claims. Our literature reviews and gap analyses provide:
COA selection, identifying the best instruments to document treatment benefits
Highlighted areas that need further research or development
Access some of our latest publications in this area
Leverage expert consensus to define clinical problems and treatment approaches. Delphi Panels/SEE quantify expert feedback to reach an agreement that can be used in clinical practice. Our process helps:
Achieve consensus on how to diagnose patients or develop treatment algorithms
Quantify expert feedback, ensuring a coherent and actionable definition of clinical issues
Access some of our latest publications in this area
Capture data directly from patients to determine which treatment attributes matter most. This method ensures that patient preferences are prioritized over expert opinions or surrogate endpoints through:
Treatment attribute prioritization, understanding what matters to patients in their treatments
Health state valuation, determining the value patients place on specific health states
Access some of our latest publications in this area
Gain deep insights into patient experiences throughout the clinical trial process to reveal the true burden of disease, understand the patient experience during treatment, and assess the impact of treatment. As a pioneer of including in-trial interview data into FDA submissions, we conduct patient interviews:
At entry before patients receive treatment to characterize the burden of disease, previous treatment experience, expectations following treatment, behavioral strategies for dealing with disease and coping strategies used by patients
Interim during the treatment period to understand what is happening to patients and why they may discontinue treatment
At exit after treatment to evaluate what changes occurred in the patient’s voice independent of standardized assessments, to determine if those changes were meaningful to patients and patient satisfaction with the intervention
Access some of our latest publications in this area
Effectively integrate the patient perspective into clinical development by measuring what truly matters to patients. Our comprehensive approach ensures that your labeling claims are robust and your marketing and diagnostic tools are impactful. We evaluate, develop and modify COAs, including PROs, ClinROs, ObsROs, and PerfOs, to support:
Regulatory labeling claims, ensuring accurate communication of benefits and risks to patients and providers and differentiation for your product
Marketing and promotion, leveraging on-label or “label worthy” data to improve access to your treatment by educating patients and providers
Screening and diagnostic tools, in order to accurately identify populations for treatment and to ensure the right patients are included in clinical trials
Access some of our latest publications in this area
Navigate complex measurement challenges with a team of psychometric scientists that bridges sophisticated methods and practical solutions. We combine deep expertise in measurement theory with real world implementation strategies to create compelling evidence packages that satisfy regulatory requirements. Our team supports all types of COAs through:
Strategic measurement planning, that satisfies both scientific standards and regulatory expectations
Collaborative partnerships, that translate complex psychometric findings into clear, actionable insights for diverse audiences
Access some of our latest publications in this area
Leverage existing clinical trial datasets to conduct exploratory analyses of COA data, informing publications, scientific communications, and broader value evidence strategies. Our post hoc COA analyses provide a deeper view into treatment impact on symptoms, functioning, and health-related quality of life (HRQoL) beyond the trial endpoints. This approach is particularly valuable for:
Publication strategy, generating new, publication-ready evidence from data already collected
Subgroup and responder analyses, identifying which patient populations derive the greatest benefit
Value evidence generation, supplementing HTA submissions and payer dossiers with additional COA-based evidence
Lifecycle and label strategy, surfacing findings that may support label expansion or future study design
Access some of our latest publications in this area
Ensure that PRO data is a key component for evaluating patient-centered benefits in JCAs and in HTA assessments. Clinical effectiveness and safety data included in JCAs should include robust evidence directly from patients. We can help you to:
PRO Strategy, ensure that your PRO strategy is developed early and with consideration to a JCA so that valid, reliable and responsive endpoints are included in clinical trials to document treatment benefit and address outcomes of interest in the JCA Core Outcome Set. Further, ensure that the PROs are integrated into the comparative evidence package
Ensure that your team has partnered with leading experts in the field to best leverage the data, particularly around the meaningfulness of any changes observed, in your JCA dossier to position you for success in your HTA submissions
Find our more about our EU HTA and JCA expertise
Optimize your clinical trial design and increase the chances for labeling success with our consulting services. We offer strategic advice on including COAs and other endpoints to support labeling claims in both the United States and Europe including:
Regulatory knowledge, enhancing trial design with specialized expertise
Endpoint strategy, ensuring COAs and endpoints effectively support labeling claims
Access some of our latest publications in this area
Describe rare or little-known diseases from the patient’s perspective to inform regulatory submissions, clinicians, and payers. Our natural history studies provide a comprehensive view into disease burden, diagnostic journey, and live patient experience of symptoms, impacts, and health-related quality of life (HRQoL). This approach is particularly valuable for:
Rare/orphan diseases, offering a comprehensive step in disease description
Understanding disease burden, providing insights into patient experiences
Access some of our latest publications in this area
Select the most appropriate COAs for your clinical trials to enhance the likelihood of detecting treatment effects and substantiating labeling claims. Our literature reviews and gap analyses provide:
COA selection, identifying the best instruments to document treatment benefits
Highlighted areas that need further research or development
Access some of our latest publications in this area
Leverage expert consensus to define clinical problems and treatment approaches. Delphi Panels/SEE quantify expert feedback to reach an agreement that can be used in clinical practice. Our process helps:
Achieve consensus on how to diagnose patients or develop treatment algorithms
Quantify expert feedback, ensuring a coherent and actionable definition of clinical issues
Access some of our latest publications in this area
Capture data directly from patients to determine which treatment attributes matter most. This method ensures that patient preferences are prioritized over expert opinions or surrogate endpoints through:
Treatment attribute prioritization, understanding what matters to patients in their treatments
Health state valuation, determining the value patients place on specific health states
Access some of our latest publications in this area

Our Impact

600+
Patient-Centered Outcomes projects executed, demonstrating our extensive experience
120+
Pharma and biotech clients supported
5,000+
Patient, caregiver, and clinician interviews conducted
20+
Therapeutic areas, including 60+ rare disease indications
200+
Peer-reviewed publications, posters, and presentations covering methodologic issues and results of trials
Our Perspectives View all perspectives
Let's Talk

We would love to hear your challenges and discuss how our patient-centered outcomes experts can help.

Margaret Vernon PhD Global Practice Lead, Value, Access & Outcomes
Read more about Margaret Vernon
Brooke Witherspoon Vice President, Head of Patient-Centered Outcomes
Read more about Brooke Witherspoon
Christopher J Evans MPH, PhD Chief Scientific Officer, Patient-Centered Outcomes
Read more about Christopher J Evans
Brandon Foster PhD Vice President, Psychometrics & Statistics, Patient-Centered Outcomes
Read more about Brandon Foster
Martha Gauthier MA Vice President, Qualitative Science Lead, Patient-Centered Outcomes
Read more about Martha Gauthier
Laura Tesler Waldman PhD Senior Director, Patient-Centered Outcomes
Read more about Laura Tesler Waldman
Julie Whyte MPH Director, Patient-Centered Outcomes
Read more about Julie Whyte