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.
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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.
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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
June 10, 2025
<p><a href="/education-training/webinars">Back to all webinars</a></p><h4>Open to all ISPOR Members and Non-members</h4><p><em><strong><br /></strong></em><strong>Title: </strong>ADHD, GLP-1s, & HIV: Real-World Trends in Prescribing and Adherence</p><p><strong>Tuesday, June 10, 2025<br /></strong>12:00PM EDT | 5:00PM UTC | 7:00PM CEST<em></em><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=ISPOR+Educational+Webinar%3A+Distributional+Cost-Effectiveness+Analysis+to+Inform+Healthcare+Decisions&iso=20220623T11&p1=12&ah=1" data-sf-ec-immutable=""></a></p><p><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=ADHD%2C+GLP-1s%2C+%26+HIV%3A+Real-World+Trends+in+Prescribing+and+Adherence&iso=20250610T13&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a><br /><br />Registration coming soon.</p><p><p=""><strong>Description</strong></p=""> </p><div><div><p paraid="1095479579" paraeid="{de6772e6-a3df-4c69-ae13-e899f6f8dc00}{175}">Why are ADHD diagnoses rising among adults? What’s driving GLP-1 discontinuation despite its transformative potential? Why do some patients remain on injectable HIV prevention while others abandon it? Real-world evidence is revealing surprising trends and critical gaps in diagnosis, prescribing, and adherence. In this exclusive webinar, Truveta researchers will share key insights from four new studies presented at ISPOR 2025, demonstrating how Truveta Data can uncover real-world practice patterns for high-profile therapies faster than any clinical trial or registry. </p><p paraid="1095479579" paraeid="{de6772e6-a3df-4c69-ae13-e899f6f8dc00}{175}"><strong>Learning Objectives</strong></p><ul paraid="1095479579" paraeid="{de6772e6-a3df-4c69-ae13-e899f6f8dc00}{175}"><li>Shifting treatment patterns: How FDA approval of GLP-1 Receptor Agonists for cardiovascular disease influenced prescribing trends – and why use may already be declining.</li><li>Drivers of discontinuation: Why patients stop GLP-1 therapy and how reasons differ between obesity and diabetes treatment.</li><li>Adherence challenges in HIV care: What real-world data reveals about who stays on injectable cabotegravir and who drops off treatment.</li><li>New trends in ADHD diagnosis and treatment: Which demographics are experiencing a rise in ADHD diagnoses and amphetamine prescribing.</li></ul><p>Why Truveta Data? <br />Truveta Data is the most representative, complete, and timely patient journey data, exceeding FDA standards for data quality, provenance, and audit readiness. Researchers can analyze de-identified EHR data from over 120 million patients, including more than 7 billion clinical notes and 100 million medical images – across all care settings.<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;"></strong></p></div></div><div><p> </p><p><strong>Moderator:</strong></p><p><strong>Ryan Ahern, MD, MPH</strong>, Chief Medical Officer and Co-Founder, Truveta, Bellevue, WA, USA</p><p><strong>Speaker:</strong></p><p><strong></strong><strong>Brianna Cartwright, MS</strong>, Principal Research Analyst, Truveta, Bellevue, WA, USA</p><p><br /></p><p><strong>Brought to you by: </strong><a href="https://www.truveta.com/truveta-data/" data-sf-ec-immutable="">Truveta</a></p></div><p paraid="271259179" paraeid="{8d771561-2af9-432a-af6d-681df4398e6a}{103}"><strong><br />Please note:</strong> On the day of the scheduled webinar, the <strong>first 1000 registered participants</strong> will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the <a href="/education-training/webinars" rel="noopener noreferrer" target="_blank">ISPOR Educational Webinar Series webpage</a> approximately 2 days after the scheduled Webinar.</p><div>Reservations are on a first-come, first-served basis.</div>)
Short Courses & Webinars
June 10, 2025
<p><a href="/education-training/webinars">Back to all webinars</a></p><h4>Open to all ISPOR Members and Non-members</h4><p><em><strong><br /></strong></em><strong>Title: </strong>ADHD, GLP-1s, & HIV: Real-World Trends in Prescribing and Adherence</p><p><strong>Tuesday, June 10, 2025<br /></strong>12:00PM EDT | 5:00PM UTC | 7:00PM CEST<em></em><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=ISPOR+Educational+Webinar%3A+Distributional+Cost-Effectiveness+Analysis+to+Inform+Healthcare+Decisions&iso=20220623T11&p1=12&ah=1" data-sf-ec-immutable=""></a></p><p><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=ADHD%2C+GLP-1s%2C+%26+HIV%3A+Real-World+Trends+in+Prescribing+and+Adherence&iso=20250610T13&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a><br /><br />Registration coming soon.</p><p><p=""><strong>Description</strong></p=""> </p><div><div><p paraid="1095479579" paraeid="{de6772e6-a3df-4c69-ae13-e899f6f8dc00}{175}">Why are ADHD diagnoses rising among adults? What’s driving GLP-1 discontinuation despite its transformative potential? Why do some patients remain on injectable HIV prevention while others abandon it? Real-world evidence is revealing surprising trends and critical gaps in diagnosis, prescribing, and adherence. In this exclusive webinar, Truveta researchers will share key insights from four new studies presented at ISPOR 2025, demonstrating how Truveta Data can uncover real-world practice patterns for high-profile therapies faster than any clinical trial or registry. </p><p paraid="1095479579" paraeid="{de6772e6-a3df-4c69-ae13-e899f6f8dc00}{175}"><strong>Learning Objectives</strong></p><ul paraid="1095479579" paraeid="{de6772e6-a3df-4c69-ae13-e899f6f8dc00}{175}"><li>Shifting treatment patterns: How FDA approval of GLP-1 Receptor Agonists for cardiovascular disease influenced prescribing trends – and why use may already be declining.</li><li>Drivers of discontinuation: Why patients stop GLP-1 therapy and how reasons differ between obesity and diabetes treatment.</li><li>Adherence challenges in HIV care: What real-world data reveals about who stays on injectable cabotegravir and who drops off treatment.</li><li>New trends in ADHD diagnosis and treatment: Which demographics are experiencing a rise in ADHD diagnoses and amphetamine prescribing.</li></ul><p>Why Truveta Data? <br />Truveta Data is the most representative, complete, and timely patient journey data, exceeding FDA standards for data quality, provenance, and audit readiness. Researchers can analyze de-identified EHR data from over 120 million patients, including more than 7 billion clinical notes and 100 million medical images – across all care settings.<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;"></strong></p></div></div><div><p> </p><p><strong>Moderator:</strong></p><p><strong>Ryan Ahern, MD, MPH</strong>, Chief Medical Officer and Co-Founder, Truveta, Bellevue, WA, USA</p><p><strong>Speaker:</strong></p><p><strong></strong><strong>Brianna Cartwright, MS</strong>, Principal Research Analyst, Truveta, Bellevue, WA, USA</p><p><br /></p><p><strong>Brought to you by: </strong><a href="https://www.truveta.com/truveta-data/" data-sf-ec-immutable="">Truveta</a></p></div><p paraid="271259179" paraeid="{8d771561-2af9-432a-af6d-681df4398e6a}{103}"><strong><br />Please note:</strong> On the day of the scheduled webinar, the <strong>first 1000 registered participants</strong> will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the <a href="/education-training/webinars" rel="noopener noreferrer" target="_blank">ISPOR Educational Webinar Series webpage</a> approximately 2 days after the scheduled Webinar.</p><div>Reservations are on a first-come, first-served basis.</div>)