QualityMetric, an IQVIA business (QM), has contracted with LunaPBC to build a patient-driven oncology instrument for measuring the impacts on physical functioning across many cancers.
Cancer group leaders are encouraged to join in this effort to ensure the voice of their community is incorporated. Partnering groups will have access to aggregate and group-specific insights to conduct follow-on research or build their own surveys to address areas such as unmet clinical needs and improper care management.
This project aligns with the FDA’s Core Patient-Reported Outcomes in Cancer Clinical Trials guidance document which recommends sponsors collect a core set of PRO concepts in cancer clinical trials and related considerations for instrument selection and trial design. The output of this project will be a new validated physical functioning instrument reflective of patient’s priorities and lived experience with cancer for use in clinical trials.
A cornerstone of this project is Luna’s unbiased group listening methodology, Community Driven Innovation (CDI), combined with QM’s PRO measurement expertise to deliver a regulatory-grade validated instrument in approximately 12 months. Besides saving many months of valuable time and costs, this process delivers more representative assessment of the experience and goals of patients, and enables clearer and broader opportunities for clinically-relevant endpoints, including quality of life measures.
CDI is a component of Luna’s digital community-to-discovery platform that seamlessly integrates registry database architecture and validated ePRO and eCOA solutions for multimodal and longitudinal data aggregation, on a cloud-based data visualization and analytics environment that operates in compliance with worldwide consumer data privacy laws.
In addition to aligning with the FDA guidance, this new physical functioning instrument will be cross-calibrated with QM’s SF-36v2 physical functioning scale in order to leverage the vast interpretation guidelines accumulated over the last 30 years of clinical research with the SF-36v2.
“This instrument will be part of an ongoing longitudinal effort to build natural history of disease data. Such natural history data will provide clinical trial investigators invaluable context for the interpretation of clinical trial outcomes.” Stated Mark Kosinski, Chief Commercial Officer, QM.
In this study, participants are asked to take a 15-20 minute survey and share answers to key questions about physical functioning using a simple audio recording intake method.
The study is open to individuals who are 13 years of age or older, who are currently managing cancer or who have ever had cancer.
Advocacy or research groups interested in learning more may contact, Aspen Perry, Marketing Manager with QualityMetric, to set up a meeting with QM’s senior science team.
Those interested in participating can join now by visiting: Luna’s Cancer Innovation Community
Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.
Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.
By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.
QualityMetric works with the world’s leading healthcare and life sciences companies to measure and better understand outcomes through the creation, administration, and review of general and patient-specific health surveys. Founded in 1997, QM combines its proprietary scientifically validated general health and disease specific surveys with its enabling technology, advanced analytics, and sector expertise to work with all the world’s largest pharmaceutical companies in clinical trials and patient surveillance. For more information, please visit: QualityMetric.com
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