Patient-Centered Outcomes

Transform Patient Insights to Unlock the True Value of Your Medicines

Patient Voices Amplify Breakthrough Value

With extensive experience in regulatory interactions from pre-IND to phase 3 and expertise in FDA/EMA guidance, 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. We gather reliable, actionable patient data that can enhance care strategies, substantiate therapeutic efficacy, and improve your medicine’s value. Our collaborative approach ensures these insights seamlessly complement your broader research initiatives, driving better patient outcomes and informed decision making.

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

Our Offerings

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 develop COAs, including PROs, ClinROs, ObsROs, and PerfOs, to support:

Regulatory labeling claims (FDA/EMA), ensuring compliance and differentiation for your product

Marketing and promotion, enhancing your strategies with validated instruments

Screening and diagnostic tools, providing accurate and relevant tools for patient assessment

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

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 embedded interview data into FDA submissions, we conduct patient interviews:

At entry before patients receive treatment to characterize the burden of disease

Interim during the treatment period to understand what is happening to patients and why they may discontinue treatment

At exit after treatment to evaluate noticeable changes in patient health

Describe rare or little-known diseases from the patient’s perspective to inform FDA/EMA submissions, clinicians, and payers. Our natural history studies provide a comprehensive view into disease burden, diagnostic journey, 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

Optimize your clinical trial design and increase the chances for labeling success with our consulting services. We offer strategic advice on including PROs 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 PROs and endpoints effectively support labeling claims

Leverage expert consensus to define clinical problems and treatment approaches. Delphi Panels 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

Select the most appropriate questionnaires for your clinical trials to enhance the likelihood of detecting treatment effects and substantiating labeling claims. Our literature reviews and gap analyses provide:

Questionnaire selection, identifying the best instruments to document treatment benefits

Highlighted areas that need further research or development

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

Ensure the electronic mode of questionnaire administration is equivalent to the traditional paper and pen method. Although less common now, this process is crucial when there are significant differences between electronic and paper versions. Our eCOA-equivalency services provide:

Patient testing, validating that electronic administration (eg, tablet or phone) aligns with paper and pen administration