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
October 22, 2025
<p><a href="/education-training/webinars">Back to all webinars</a></p><p><strong>Title: </strong>The Case for Integrated RWE Generation Across the Product Lifecycle <strong><br /><br />Wednesday, October 22, 2025 <br /></strong>11:00AM EDT | 3:00PM UTC | 5:00PM CEST</p><p><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=The+Case+for+Integrated+RWE+Generation+Across+the+Product+Lifecycle&iso=20251022T11&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a></p><a href="https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=2afccd29-206c-4a12-9f28-055ed7d6224a&RegPath=EventRegNoFees&FreeEvent=1&Event=ISPOR%20Webinar:%20The%20Case%20for%20Integrated%20RWE%20Generation%20Across%20the%20Product%20Lifecycle&FundraisingEvent=0&evt_guest_limit=0" class="button primary" data-sf-ec-immutable="">Register Now</a> <p> </p><p><strong>Description</strong></p><p><strong></strong>Integrated real-world evidence (RWE) generation strategies are increasingly recognized as essential for portfolio planning, clinical development decision making, and commercialization. However, RWE generation is often not done systematically or early enough to efficiently meet development needs, typically due to budget considerations. At the portfolio level, companies need to ensure their real-world data (RWD) investments meet the needs of all assets and that evidence is timely to facilitate evidence-based portfolio decisions. At the asset/program level, robust RWE on the indicated population—collected early and updated regularly—is essential to support decision making throughout development and commercialization. This webinar will arm health economics and outcomes research (HEOR) and Market Access leaders and scientists with compelling arguments for investment in RWD/E at the portfolio level and across the asset/program lifecycle. <br /></p><p><br /><strong><br />Learning Objectives</strong></p><div><ul paraid="59022216" paraeid="{5f256630-c8df-40c1-8766-f3f29171a258}{199}"><li>Describe how robust, timely RWE can support efficient and well-informed evidence-based decision making at both the portfolio and asset/program levels. </li><li>Explain the strategic importance of integrated real-world data and evidence (RWD/E) generation for portfolio planning, clinical development, and commercialization across the biopharma lifecycle. </li><li>Discuss how to communicate the value and impact of strategic RWD/E investments to internal stakeholders and leadership teams to support evidence-driven decision –making and optimally demonstrate product value. </li></ul></div><p> </p><p><strong>Moderator:</strong></p><p><strong>Nicolle Gatto, MD, MPH</strong>, Chief Science Officer, Aetion, a Datavant Company, New York, NY, USA<br /></p><p><em> </em></p><p><em>Sponsored by Corporate Partner, <a href="https://aetion.com/" data-sf-ec-immutable="">Aetion</a>.</em><em></em></p><p><img sf-image-responsive="true" src="/images/default-source/cti-meeting-21021-images/a464-1-png.png?sfvrsn=153a0f15_0" height="149" title="a464_1.png" width="163" alt="" sf-size="300568" /></p><p>Please note: On the day of the scheduled webinar, the first 1000 registered participants 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">ISPOR Educational Webinar Series webpage</a> approximately 2 days after the scheduled Webinar. Reservations are on a first-come, first-served basis.</p>)
Short Courses & Webinars
October 22, 2025
<p><a href="/education-training/webinars">Back to all webinars</a></p><p><strong>Title: </strong>The Case for Integrated RWE Generation Across the Product Lifecycle <strong><br /><br />Wednesday, October 22, 2025 <br /></strong>11:00AM EDT | 3:00PM UTC | 5:00PM CEST</p><p><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=The+Case+for+Integrated+RWE+Generation+Across+the+Product+Lifecycle&iso=20251022T11&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a></p><a href="https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=2afccd29-206c-4a12-9f28-055ed7d6224a&RegPath=EventRegNoFees&FreeEvent=1&Event=ISPOR%20Webinar:%20The%20Case%20for%20Integrated%20RWE%20Generation%20Across%20the%20Product%20Lifecycle&FundraisingEvent=0&evt_guest_limit=0" class="button primary" data-sf-ec-immutable="">Register Now</a> <p> </p><p><strong>Description</strong></p><p><strong></strong>Integrated real-world evidence (RWE) generation strategies are increasingly recognized as essential for portfolio planning, clinical development decision making, and commercialization. However, RWE generation is often not done systematically or early enough to efficiently meet development needs, typically due to budget considerations. At the portfolio level, companies need to ensure their real-world data (RWD) investments meet the needs of all assets and that evidence is timely to facilitate evidence-based portfolio decisions. At the asset/program level, robust RWE on the indicated population—collected early and updated regularly—is essential to support decision making throughout development and commercialization. This webinar will arm health economics and outcomes research (HEOR) and Market Access leaders and scientists with compelling arguments for investment in RWD/E at the portfolio level and across the asset/program lifecycle. <br /></p><p><br /><strong><br />Learning Objectives</strong></p><div><ul paraid="59022216" paraeid="{5f256630-c8df-40c1-8766-f3f29171a258}{199}"><li>Describe how robust, timely RWE can support efficient and well-informed evidence-based decision making at both the portfolio and asset/program levels. </li><li>Explain the strategic importance of integrated real-world data and evidence (RWD/E) generation for portfolio planning, clinical development, and commercialization across the biopharma lifecycle. </li><li>Discuss how to communicate the value and impact of strategic RWD/E investments to internal stakeholders and leadership teams to support evidence-driven decision –making and optimally demonstrate product value. </li></ul></div><p> </p><p><strong>Moderator:</strong></p><p><strong>Nicolle Gatto, MD, MPH</strong>, Chief Science Officer, Aetion, a Datavant Company, New York, NY, USA<br /></p><p><em> </em></p><p><em>Sponsored by Corporate Partner, <a href="https://aetion.com/" data-sf-ec-immutable="">Aetion</a>.</em><em></em></p><p><img sf-image-responsive="true" src="/images/default-source/cti-meeting-21021-images/a464-1-png.png?sfvrsn=153a0f15_0" height="149" title="a464_1.png" width="163" alt="" sf-size="300568" /></p><p>Please note: On the day of the scheduled webinar, the first 1000 registered participants 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">ISPOR Educational Webinar Series webpage</a> approximately 2 days after the scheduled Webinar. Reservations are on a first-come, first-served basis.</p>)