Short Course on Patient Engagement in Medical-Product Research
Join members of the ISPOR Patient Centered Special Interest Group on 22-23 June 2022 at 10:00AM – 12:00PM EST for a 4-hour short course (course runs 2 consecutive days, 2 hours each day) on “Introduction to Patient Engagement in Medical-Product Research.” This course is designed to provide participants with an introduction to patient engagement (PE) in medical-product research through defining PE and providing its historical context and significance throughout ISPOR’s HEOR taxonomy. This course will also equip attendees with tools to plan and implement meaningful PE activities in their respective areas of research expertise (e.g., clinical development, epidemiology, health economics, real-world evidence, etc.) One of the course’s strengths is that attendees will have the opportunity to interact with stakeholders who represent a variety of perspectives. Interaction with stakeholders and other attendees may also result in unique opportunities for further collaboration in PE medical-product research. For more information and registration, please visit here.
Update from ISPOR Task Forces and Good Practices Reports
- New Task Force Report Published
A global expert panel published and updated consolidated health economic evaluation reporting standards (CHEERS). The report, “Consolidated Health Economic Evaluation Reporting Standards 2022 Explanation and Elaboration: A Report of the ISPOR Economic Evaluation Guidelines Good Research Practices Task Force II,” was published in the January 2022 issue of the Society’s official Journal, Value in Health, and replaces previous CHEERS reporting guidance.
The recent webinar on CHEERS 2022 - Reporting Guidance for Health Economic Evaluation: What It Is and How to Use It focused on the major changes between the original 2013 CHEERS and this updated guidance. It will help authors provide accurate information on which health interventions are being compared and in what context, how the evaluation was undertaken, what the findings are, and other details that will aid readers, reviewers and decision makers in the interpretation and use of studies. It can also aid those interested in replicating research findings. For videos on the checklist items and other resources, visit ISPOR CHEERS 2022 Resources.
- Educational Webinar on Performance Outcome Assessment Emerging Good Practices Task Force
The ISPOR Performance Outcome Assessment Emerging Good Practices Task Force presented “Improving Performance: Selection and Development of PerfO Assessments to Capture Clinical Benefit”. The webinar covers: 1) identifying the concept of interest and determining when a PerfO assessment is the optimal approach to measurement; 2) identifying, selecting, or modifying existing PerfO assessments or developing new ones and 3) challenges when evaluating content validity of PerfO assessments. Watch the webinar on-demand here.
Update from ISPOR Special Interest Groups
- Updates from the ISPOR Patient Centered Special Interest Group
- New Leadership of the SIG Announced
ISPOR is pleased to announce new leaders of the Eleanor Perfetto, PhD, MS, Professor of Pharmaceutical Health Service Research, University of Maryland School of Pharmacy, Baltimore, MD, USA, and Jessica Roydhouse, PhD, Select Foundation Senior Research Fellow in Health Services Research, Menzies Institute for Medical Research, University of Tasmania, Australia as the incoming Chair and Chair-Elect of the Special Interest Group, respectively. The SIG will be sending out a survey to gain member feedback on topics and activities related to patient engagement. For the first time, “patient engagement” is included in ISPOR’s Top 10 HEOR Trends. To sign up to be in the SIG and for more information on the ISPOR Patient Centered Special Interest Group, please see here.
- ISPOR Short Course Focused on an “Introduction to Patient Engagement in Medical-Product Research”Join members of the ISPOR Patient Centered Special Interest Group on 22-23 June 2022 at 10:00AM – 12:00PM EST for a 4-hour short course (course runs 2 consecutive days, 2 hours each day) on “Introduction to Patient Engagement in Medical-Product Research.” This course is designed to provide participants with an introduction to patient engagement (PE) in medical-product research through defining PE and providing its historical context and significance throughout ISPOR’s HEOR taxonomy. This course will also equip attendees with tools to plan and implement meaningful PE activities in their respective areas of research expertise (e.g., clinical development, epidemiology, health economics, real-world evidence, etc.) One of the course’s strengths is that attendees will have the opportunity to interact with stakeholders who represent a variety of perspectives. Interaction with stakeholders and other attendees may also result in unique opportunities for further collaboration in PE medical-product research. For more information and registration, please visit here.
Dialogue with Decision Makers
- ISPOR Responds to US FDA Call for Comments
The US Food and Drug Administration recently posted a draft guidance entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision on effectiveness or safety. ISPOR, with the help of members representing various councils and special interest groups, provided comments.
- Virtual ISPOR Health Technology Assessment Roundtable – Europe 2021
On 23 November 2021, 24 attendees from 20 different European countries convened for the Virtual ISPOR HTA Roundtable-Europe. This year the Roundtable focused on two relevant topics: 1) The Role of HTA in Assessing Digital Technologies and Virtual Care and 2) HTA of Potentially Curative Therapies (ATMP). Presentations from HTA Bodies and Academicians (National Health Fund HQ, INFARMED, IQWiG, Gdańsk Medical University, AIFA) among others, discussed the needs to adapt and organize HTA activities around emerging trends. Learn more about HTA Roundtables here.
- ISPOR Convenes Virtual 2021 Patient Representatives Roundtable – Europe
The ISPOR 2021 Patient Representatives Roundtable–Europe convened virtually on 9 December 2021 to discuss patient-generated data and evidence in health technology assessment. More than 30 representatives from various patient organizations, research and academia, health technology assessment bodies, life sciences industry, and regulatory agencies participated in the discussion. Some of the participating organizations included EUPATI, IPPOSI, IAPO, European Commission and EMA. Learn more about Patient Representatives Roundtables here.
HEOR Resources
- Assessing the Evidence for Health Care Decision Makers
ISPOR is updating the Assessing the Evidence for Health Care Decision Makers tool. If you currently utilize this tool, we kindly ask that you log into https://www.healthstudyassessment.org/ and save any study review assessment data you would like to keep in your own file by February 28, 2022. After this date, you will not be able to access your data. More information to come on the New Assessing the Evidence for Health Care Decision Makers.
This year, “health technology assessment” has made the Top 10 HEOR Trends list for the first time, and it is also a key theme in the ISPOR Science Strategy! ISPOR’s Health Technology Assessment (HTA) Central provides a comprehensive repository of resources and tools to support HTA and informed healthcare decisions!
HTA Central is freely available to all and offers information on HTA-related news pertaining to Asia Pacific, Europe, Latin America, Middle East & Africa, and North America, and answers all of your HTA questions on how to promote an equitable, efficient, and high-quality health system, the steps for conducting a thorough health technology assessment, and much more! Visit the ISPOR HTA Central to see our new look and to learn more about HTA. Click here to explore.