Expert Review of Pharmacoeconomics & Outcomes Research – How can digital endpoints empower patients?
About the special issue
Digital endpoints introduce novel methods for real world evidence generation by collecting data directly from patients via wearable sensors or smartphone applications.
There are two types of digital endpoints distinguished by regulatory bodies: Digital Biomarker (BM) and Electronic Clinical Outcome Assessments (eCOA). BM is an indicator of a process or response to an exposure/intervention; whereas eCOA is a measure of how patients feel, function or survive; both being derived from a digital measure.
Digital endpoints transfers clinical assessments to the home environment, providing clinically meaningful measurements of patient’s health and significantly reducing the burden associated with participation in clinical trials or excessive clinician consultations.
Digital endpoints introduce greater objectivity by replacing often subjective human observation with digital data, and greater precision in the long-term. Given the purpose of continuous real-world data collection, digital endpoints offer valuable insights into disease progression which can be adopted into data driven decision making.
Digital endpoints present unique challenges, not only intrinsically, but also in their adoption and application in the healthcare ecosystem. Reporting and understanding of digital endpoints in the context of the value assessment of pharmaceuticals and medical devices is lacking, despite their growing use in ongoing studies. Alignment and collaboration across regulatory and reimbursement bodies as well as the healthcare industry is paramount.
Expert Review of Pharmacoeconomics & Outcomes Research, alongside Guest Advisor Professor Katarzyna Kolasa, is excited to present a first-of-its-kind opportunity to contribute to a unique knowledge base of best practice in digital endpoint studies.
Potential submissions could include: – Studies involving digital endpoints e.g. retrospective data analyses, observational studies – Recommendations for the implementation of digital endpoints assessments into health economics and outcomes research guidelines – Discussion of the role of digital endpoints in building upon the patient-centric healthcare ecosystem -Evidence of how digital endpoints can support value generation
We welcome submissions of Original Research, Reviews, Perspectives, Meeting Reports and Editorials for consideration in this special focus issue.
If you are interested in contributing or would like to learn more, then please reach out to the Commissioning Editor, James Crosby, who will be happy to assist.
About the Guest Advisor:
Driven by the mission to meet healthcare challenges, Katarzyna has gained extensive academic and industry experience in the field of health economics.
While holding various Regional and Global leadership positions at Astra Zeneca, BMS, Biogen Idec, Lundbeck, GE Healthcare, Straub Medical, and Swedish local payer, she has been working with multiple pricing & reimbursement submissions for medical technologies worldwide. Being an experienced mentor, she has supported many health-tech startups in the value proposition development.
She is the founder of the Global Special Interest Group Digital Health at ISPOR—The Pro-fessional Society for Health Economics and Outcomes Research. Katarzyna is also the leader for short courses “The Role of Digital Endpoints in the Value Generation for Health Technologies” and “RiskSharing/Performance-Based Arrangements in Developing Countries” at ISPOR. She is the member of Educational Council at ISPOR as well.
Katarzyna has dedicated her academic research towards the methodological advancements into the value assessment of pharmaceuticals, medical devices and digital health solutions.
In partnership with the Polish Medical Research Agency, Deloitte Digital, and the Polish Central Hospital of Ministry of Interior Affairs, she established the first Digital Health Start Me Up six-month educational program designed for health-tech and digital transformation leaders working in the healthcare sector. Katarzyna is also the founder of the Master Program Health Economics & Big Data (HEBDA) which first edition was financed by EU Power Grant 2018.
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