Real-world evidence on treatment outcomes can be an important aspect of the evidence basis for decision making if it is seen as credible. For real-world studies that are meant to test hypotheses about comparative-effectiveness or safety, a key aspect of credibility is that they are conducted transparently with tests that follow a prespecified analytic protocol. Preregistration of such study protocols on a public website would help build trust that their results can be used for decision-making purposes.
Establishing a Culture of Transparency for Real-World Evidence Studies...
The Real-World Evidence Transparency Initiative Partnership is a joint collaboration and ongoing effort between ISPOR, the International Society for Pharmacoepidemiology, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council. The objective of this initiative is to establish a culture of transparency for study analysis and reporting of hypothesis evaluating real-world evidence studies on treatment effects.
Improving Transparency to Build Trust...
The Real-World Evidence Transparency Initiative published a plan to encourage routine registration of noninterventional real-world evidence studies used to evaluate treatment effects. The report, “Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing—Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative,”
was published in the September 2020 issue of Value in Health.
More...
The report, “Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing—Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative,” was published in the September 2020 issue of Value in Health. The plan includes specifying the rationale for registering hypothesis-evaluating treatment effectiveness real-world evidence studies, the studies that should be registered, where and when these studies should be registered, how and when analytic deviations from protocols should be reported, how and when to publish results, and incentives to encourage registration.
Real-World Evidence Registry
The Real-World Evidence Registry provides researchers with a fit-for-purpose platform to register their study designs before they begin work to facilitate the transparency needed to elevate the trust in the study results.
More...
Real-world evidence studies can be used for hypothesis evaluation of treatment effects including safety (HETE studies). However these studies can also be perceived as less rigorous than clinical trials especially when not preregistered in a public setting such as ClinicalTrials.gov or the EU-PAS register.
ISPOR and its partners ISPE, NPC, and Duke Margolis have developed a simplified registration site especially for RWE HETE studies using secondary data. This searchable site provides a place for preregistration of studies that may not require registration for regulatory purposes but benefit from the rigor of transparent study methods and also provide a reference (such as a URL or doi) to share with peer reviewers, assessors, or other decision making bodies. Researchers can get started ‘here’ by creating a profile on the Open Sciences Framework and registering their study on the RWE Registry.
Shaking the Myth of Real-World Evidence
On-Demand Webinar
Learn more by watching the on-demand webinar, “Shaking the Myth of Real-World Evidence: Updates from the RWE Transparency Initiative.” This session provides updates from the initiative including a walk-through of the study registration site and updates on the special task force developing a standardized RWE protocol template.
Additional Resources
- Real-World Evidence Registry
- Good Practices Reports and Other ISPOR Reports from Value in Health
- HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force
- "Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing—Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative"
- "Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness"
- "Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0"
- "Unlocking the Promise of Real-World Evidence" (Value & Outcomes Spotlight, Vol. 6, No. 5)
- ISPOR's Real-World Evidence Strategic Initiatives
Conferences & Summits
September 23, 2026
<div><p><strong data-start="173" data-end="280">Strengthen Your Approach to Evaluating Digital Health, Medical Devices, and Pharmaceutical Technologies</strong></p><p data-start="282" data-end="753">Traditional health technologies are often grouped into pharmaceuticals, medical devices, and digital health technologies (DHTs). While pharmaceuticals and devices have long-standing evaluation pathways, DHTs introduce new complexities due to rapid innovation, diverse evidence needs, and distinct regulatory considerations. These differences make comparing and evaluating these technologies challenging, particularly when assessing long-term clinical and economic impact.</p><p data-start="755" data-end="1033">This course provides an overview of how these three categories differ in clinical use, evidence availability, and methodological requirements. Participants will explore common evaluation and modeling challenges and learn how to adapt analytic approaches across technology types.</p><p data-start="1035" data-end="1064"><strong data-start="1035" data-end="1064">Technical Topics Include:</strong></p><p data-start="1066" data-end="1350">• Key differences across pharmaceuticals, medical devices, and digital health technologies<br data-start="1156" data-end="1159" />• Evidence needs, outcome measurement, and decision-making contexts<br data-start="1226" data-end="1229" />• Common modeling challenges across technology categories<br data-start="1286" data-end="1289" />• Considerations for selecting appropriate model structures</p><p data-start="1352" data-end="1449"><strong data-start="1352" data-end="1449">This Course Includes Practical Tools and Concepts That Can Be Immediately Applied, Including:</strong></p><p data-start="1451" data-end="1797">• Group-based critique of published case studies<br data-start="1499" data-end="1502" />• Exercises examining real-world evaluation challenges, including diagnostics<br data-start="1579" data-end="1582" />• Guidance on selecting and applying suitable modeling methods (eg, discrete event simulations, patient-level simulations, cohort models)<br data-start="1719" data-end="1722" />• Practical strategies for addressing data and methodological limitations</p></div><p><strong>LEVEL: </strong>Introductory<br /><strong>TRACK: </strong>Health Technology Assessment</p><p><a class="button primary" href="https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=fe816b19-2736-47f0-a127-c1fe7bbd1b92&RegPath=EventRegFees&FreeEvent=0&Event=Q3%202026%20Virtual%20ISPOR%20Short%20Course:%20Evaluation%20of%20Digital%20Health%20Technologies,%20Medical%20Devices,%20and%20Pharmaceuticals%20and%20the%20Challenges%20to%20Consider&FundraisingEvent=0&evt_guest_limit=0" data-sf-ec-immutable="">Register Here</a><br /></p><div><p><strong style="background-color:transparent;color:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">Faculty</strong><strong style="background-color:initial;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"></strong></p><div><div></div><div><div><strong>Hayden Holmes, PGDip</strong></div><div>Director, Digital Health Technologies Consulting<div><div>York Health Economics Consortium<div></div></div>University of York </div><div>York, England, UK</div><div><br /></div><div><strong>Angel Varghese, MSc</strong></div><div>Project Director</div><div>York Health Economics Consortium</div></div>University of York <div>York, England, UK</div><div><br /></div><div><strong>Robert Malcolm, MSc</strong></div><div>Project Director</div><div>York Health Economics Consortium</div>University of York <div>York, England, UK</div><div><br /></div><div><strong>Alison Smith, PhD</strong></div><div>University of Leeds</div><div>Leeds, England, UK<div><p> </p><p> </p><div></div><div></div><p><strong></strong><strong style="background-color:transparent;color:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;">Schedule:</strong></p><p><strong>LENGTH:</strong> 4 Hours | Course runs 2 consecutive days, 2 hours each day<strong style="background-color:transparent;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"></strong></p><div><div><p> </p><div><strong>Wednesday, 23 September 2026 | Course runs 2 consecutive days, 2 hours per day</strong></div><div>10:00AM–12:00PM Eastern Daylight Time (EDT)</div><div>15:00PM-17:00PM British Summer Time (BST)</div><div>16:00PM–18:00PM Central European Summer Time (CEST)</div><div>14:00PM–16:00PM Coordinated Universal Time (UTC)</div><div></div><div></div><div><br /></div><div><div><strong>Thursday, 24 September 2026 | Course runs 2 consecutive days, 2 hours per day</strong></div><div>10:00AM–12:00PM Eastern Daylight Time (EDT)</div><div>15:00PM-17:00PM British Summer Time (BST)</div><div>16:00PM–18:00PM Central European Summer Time (CEST)</div><div>14:00PM–16:00PM Coordinated Universal Time (UTC)</div><div></div><div><p> </p><p><span style="background-color:transparent;color:inherit;font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=September+23-24%2C+2026%3A+Virtual+ISPOR+Short+Course+%E2%80%9CEvaluation+of+DHTs+%E2%80%A6%E2%80%9D&iso=20260923T10&p1=12&ah=2" data-sf-ec-immutable="">Click for time zone conversion</a></span></p><p><a class="button primary" href="https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=fe816b19-2736-47f0-a127-c1fe7bbd1b92&RegPath=EventRegFees&FreeEvent=0&Event=Q3%202026%20Virtual%20ISPOR%20Short%20Course:%20Evaluation%20of%20Digital%20Health%20Technologies,%20Medical%20Devices,%20and%20Pharmaceuticals%20and%20the%20Challenges%20to%20Consider&FundraisingEvent=0&evt_guest_limit=0" data-sf-ec-immutable="">Register Here</a><br /></p></div></div></div><strong style="background-color:transparent;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"></strong></div><p><a href="/education-training/short-courses">Back to all short courses</a><br /><strong></strong></p><p><strong><em>ISPOR short courses are designed to enhance knowledge and techniques in core health economics and outcomes research (HEOR) topics as well as emerging trends in the field. Short courses offer 4 or 8 hours of premium scientific education and an electronic course book. Active attendee participation combined with our expert faculty creates an immersive and impactful learning experience. Short courses are not recorded and are only available during the live course presentation.</em></strong></p></div></div></div></div></div>)
Short Courses & Webinars
September 23, 2026
<div><p><strong data-start="173" data-end="280">Strengthen Your Approach to Evaluating Digital Health, Medical Devices, and Pharmaceutical Technologies</strong></p><p data-start="282" data-end="753">Traditional health technologies are often grouped into pharmaceuticals, medical devices, and digital health technologies (DHTs). While pharmaceuticals and devices have long-standing evaluation pathways, DHTs introduce new complexities due to rapid innovation, diverse evidence needs, and distinct regulatory considerations. These differences make comparing and evaluating these technologies challenging, particularly when assessing long-term clinical and economic impact.</p><p data-start="755" data-end="1033">This course provides an overview of how these three categories differ in clinical use, evidence availability, and methodological requirements. Participants will explore common evaluation and modeling challenges and learn how to adapt analytic approaches across technology types.</p><p data-start="1035" data-end="1064"><strong data-start="1035" data-end="1064">Technical Topics Include:</strong></p><p data-start="1066" data-end="1350">• Key differences across pharmaceuticals, medical devices, and digital health technologies<br data-start="1156" data-end="1159" />• Evidence needs, outcome measurement, and decision-making contexts<br data-start="1226" data-end="1229" />• Common modeling challenges across technology categories<br data-start="1286" data-end="1289" />• Considerations for selecting appropriate model structures</p><p data-start="1352" data-end="1449"><strong data-start="1352" data-end="1449">This Course Includes Practical Tools and Concepts That Can Be Immediately Applied, Including:</strong></p><p data-start="1451" data-end="1797">• Group-based critique of published case studies<br data-start="1499" data-end="1502" />• Exercises examining real-world evaluation challenges, including diagnostics<br data-start="1579" data-end="1582" />• Guidance on selecting and applying suitable modeling methods (eg, discrete event simulations, patient-level simulations, cohort models)<br data-start="1719" data-end="1722" />• Practical strategies for addressing data and methodological limitations</p></div><p><strong>LEVEL: </strong>Introductory<br /><strong>TRACK: </strong>Health Technology Assessment</p><p><a class="button primary" href="https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=fe816b19-2736-47f0-a127-c1fe7bbd1b92&RegPath=EventRegFees&FreeEvent=0&Event=Q3%202026%20Virtual%20ISPOR%20Short%20Course:%20Evaluation%20of%20Digital%20Health%20Technologies,%20Medical%20Devices,%20and%20Pharmaceuticals%20and%20the%20Challenges%20to%20Consider&FundraisingEvent=0&evt_guest_limit=0" data-sf-ec-immutable="">Register Here</a><br /></p><div><p><strong style="background-color:transparent;color:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">Faculty</strong><strong style="background-color:initial;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"></strong></p><div><div></div><div><div><strong>Hayden Holmes, PGDip</strong></div><div>Director, Digital Health Technologies Consulting<div><div>York Health Economics Consortium<div></div></div>University of York </div><div>York, England, UK</div><div><br /></div><div><strong>Angel Varghese, MSc</strong></div><div>Project Director</div><div>York Health Economics Consortium</div></div>University of York <div>York, England, UK</div><div><br /></div><div><strong>Robert Malcolm, MSc</strong></div><div>Project Director</div><div>York Health Economics Consortium</div>University of York <div>York, England, UK</div><div><br /></div><div><strong>Alison Smith, PhD</strong></div><div>University of Leeds</div><div>Leeds, England, UK<div><p> </p><p> </p><div></div><div></div><p><strong></strong><strong style="background-color:transparent;color:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;">Schedule:</strong></p><p><strong>LENGTH:</strong> 4 Hours | Course runs 2 consecutive days, 2 hours each day<strong style="background-color:transparent;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"></strong></p><div><div><p> </p><div><strong>Wednesday, 23 September 2026 | Course runs 2 consecutive days, 2 hours per day</strong></div><div>10:00AM–12:00PM Eastern Daylight Time (EDT)</div><div>15:00PM-17:00PM British Summer Time (BST)</div><div>16:00PM–18:00PM Central European Summer Time (CEST)</div><div>14:00PM–16:00PM Coordinated Universal Time (UTC)</div><div></div><div></div><div><br /></div><div><div><strong>Thursday, 24 September 2026 | Course runs 2 consecutive days, 2 hours per day</strong></div><div>10:00AM–12:00PM Eastern Daylight Time (EDT)</div><div>15:00PM-17:00PM British Summer Time (BST)</div><div>16:00PM–18:00PM Central European Summer Time (CEST)</div><div>14:00PM–16:00PM Coordinated Universal Time (UTC)</div><div></div><div><p> </p><p><span style="background-color:transparent;color:inherit;font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=September+23-24%2C+2026%3A+Virtual+ISPOR+Short+Course+%E2%80%9CEvaluation+of+DHTs+%E2%80%A6%E2%80%9D&iso=20260923T10&p1=12&ah=2" data-sf-ec-immutable="">Click for time zone conversion</a></span></p><p><a class="button primary" href="https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=fe816b19-2736-47f0-a127-c1fe7bbd1b92&RegPath=EventRegFees&FreeEvent=0&Event=Q3%202026%20Virtual%20ISPOR%20Short%20Course:%20Evaluation%20of%20Digital%20Health%20Technologies,%20Medical%20Devices,%20and%20Pharmaceuticals%20and%20the%20Challenges%20to%20Consider&FundraisingEvent=0&evt_guest_limit=0" data-sf-ec-immutable="">Register Here</a><br /></p></div></div></div><strong style="background-color:transparent;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"></strong></div><p><a href="/education-training/short-courses">Back to all short courses</a><br /><strong></strong></p><p><strong><em>ISPOR short courses are designed to enhance knowledge and techniques in core health economics and outcomes research (HEOR) topics as well as emerging trends in the field. Short courses offer 4 or 8 hours of premium scientific education and an electronic course book. Active attendee participation combined with our expert faculty creates an immersive and impactful learning experience. Short courses are not recorded and are only available during the live course presentation.</em></strong></p></div></div></div></div></div>)