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
June 30, 2026
<p><a href="/education-training/webinars">Back to all webinars</a></p><p><strong>Title: </strong>Designing for Access: Early Integrated Evidence Generation Planning in the Era of Expanded Value Frameworks <strong><br /><br />Tuesday, June 30, 2026<br /></strong>10:00AM EDT | 2:00PM UTC | 4:00PM CEST</p><p><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=Designing+for+Access%3A+Early+Integrated+Evidence+Generation+Planning+in+the+Era+of+Expanded+Value+Fra&iso=20260630T10&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a></p><p><em>Registration Coming Soon!</em><strong></strong></p><p><strong>Description</strong></p><p><strong></strong>Impactful evidence does not begin with data — it begins with strategy. <br /></p><p>As regulatory, HTA, and payer expectations continue to evolve, organizations should move from evidence generation that reactively plugs evidence gaps toward proactive, integrated evidence generation planning (IEGP). While technology and real-world evidence (RWE) are capturing the limelight in the modern HEOR agenda, they do not translate into impact unless they can affect strategically important decisions. <br /></p><p>This webinar will demonstrate how an integrated evidence strategy strategically combines perspectives from health economics and market access with patient-centered research and RWE to shape impactful decisions across the product lifecycle. The team will address complexities of planning evidence generation for HTA bodies and payers, examining differing needs, especially in terms of comparators and endpoints, applicability of evidence, and how they approach and manage uncertainties, providing practical examples and solutions. The primary focus will be on European HTA frameworks, while highlighting implications for global evidence strategies. Participants will learn how early strategy can help decision makers: </p><ul><li>Understand the breadth and depth of evidence needs and identify gaps across the lifecycle continuum; locate, develop, and synthesize “hard to reach” data essential to planning. </li><li>Define patient-relevant endpoints, align comparators and evidence and build economic models that anticipate regulatory, HTA, and payer scrutiny across global markets.</li><li>Elevate the value of clinical data beyond traditional outcomes through collection of patient experience data in clinical trials.</li><li>Develop real-world evidence strategies — including the use of a comprehensive Real-World Data Optimization framework and direct-to-patient and provider approaches to demonstrate unmet need, reduce uncertainty, and accelerate decision making.</li></ul><p>From potential to proof, this session will illustrate how organizations can translate strategy-driven IEGP into robust, decision-grade evidence that strengthens regulatory confidence, informs HTA deliberations, and enhances payer value narratives. </p><div></div><p><em><a href="https://www.ispor.org/heor-resources/good-practices/article/recommendations-on-the-use-of-structured-expert-elicitation-protocols-for-healthcare-decision-making" data-sf-ec-immutable=""></a></em></p><p><strong>Learning Objectives</strong></p><ul><li>Understand the importance of a strategy-led integrated evidence generation plan (IEGP) that aligns health economics and market access, patient-centered research, and real-world data and evidence to inform timely, cost-effective regulatory, HTA, and payer decisions from early development onward. </li><li><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;">Discern the patient experience data (PED) and direct-to-patient real-world data collection strategies that demonstrate unmet need and strengthen value narratives throughout the product lifecycle. </span></li><li>Explain how transparent, reproducible, and decision-grade economic and real-world evidence programs reduce uncertainty and enhance access outcomes in an expanded value framework environment. </li></ul><p> </p><p><strong>Moderator:</strong></p><p data-pm-slice="1 1 []"><strong>Mark Yates, MBChB (MD), PhD,</strong> Director of RWE strategy and RWD solutions, PPD Evidera Real World Data & Scientific Solutions, Thermo Fisher Scientific, London, United Kingdom</p><p><strong>Speakers:</strong><strong></strong></p><p data-pm-slice="1 1 []"><strong>Pedro Saramago Goncalves, MSc, PhD,</strong> Research Scientist, Consulting, PPD Evidera Health Economics and Market Access, Thermo Fisher Scientific, London, United Kingdom</p><p data-pm-slice="1 1 []"><strong>Sebastian Heidenreich, PhD, </strong>Executive Director, PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, London, United Kingdom</p><p data-pm-slice="1 1 []"><strong>Martin Parkinson, MRPharmS,</strong> Executive Director, EU HTA Regulation Lead Consulting, PPD Evidera Health Economics and Market Access, Thermo Fisher Scientific, London, United Kingdom<br /></p><br /><p><em>Sponsored by Corporate Partner, <a href="https://www.thermofisher.com/us/en/home.html" data-sf-ec-immutable="">Thermo Fisher Scientific</a>.</em><br /></p><em><img sf-image-responsive="true" src="/images/default-source/ispor-sponsored-content-logo/ispor-corporate-partner.png?sfvrsn=811bd2f_1" height="105" title="ispor-corporate-partner" width="115" alt="" sf-size="11595" /><br /><p></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></em>)
Short Courses & Webinars
June 30, 2026
<p><a href="/education-training/webinars">Back to all webinars</a></p><p><strong>Title: </strong>Designing for Access: Early Integrated Evidence Generation Planning in the Era of Expanded Value Frameworks <strong><br /><br />Tuesday, June 30, 2026<br /></strong>10:00AM EDT | 2:00PM UTC | 4:00PM CEST</p><p><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=Designing+for+Access%3A+Early+Integrated+Evidence+Generation+Planning+in+the+Era+of+Expanded+Value+Fra&iso=20260630T10&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a></p><p><em>Registration Coming Soon!</em><strong></strong></p><p><strong>Description</strong></p><p><strong></strong>Impactful evidence does not begin with data — it begins with strategy. <br /></p><p>As regulatory, HTA, and payer expectations continue to evolve, organizations should move from evidence generation that reactively plugs evidence gaps toward proactive, integrated evidence generation planning (IEGP). While technology and real-world evidence (RWE) are capturing the limelight in the modern HEOR agenda, they do not translate into impact unless they can affect strategically important decisions. <br /></p><p>This webinar will demonstrate how an integrated evidence strategy strategically combines perspectives from health economics and market access with patient-centered research and RWE to shape impactful decisions across the product lifecycle. The team will address complexities of planning evidence generation for HTA bodies and payers, examining differing needs, especially in terms of comparators and endpoints, applicability of evidence, and how they approach and manage uncertainties, providing practical examples and solutions. The primary focus will be on European HTA frameworks, while highlighting implications for global evidence strategies. Participants will learn how early strategy can help decision makers: </p><ul><li>Understand the breadth and depth of evidence needs and identify gaps across the lifecycle continuum; locate, develop, and synthesize “hard to reach” data essential to planning. </li><li>Define patient-relevant endpoints, align comparators and evidence and build economic models that anticipate regulatory, HTA, and payer scrutiny across global markets.</li><li>Elevate the value of clinical data beyond traditional outcomes through collection of patient experience data in clinical trials.</li><li>Develop real-world evidence strategies — including the use of a comprehensive Real-World Data Optimization framework and direct-to-patient and provider approaches to demonstrate unmet need, reduce uncertainty, and accelerate decision making.</li></ul><p>From potential to proof, this session will illustrate how organizations can translate strategy-driven IEGP into robust, decision-grade evidence that strengthens regulatory confidence, informs HTA deliberations, and enhances payer value narratives. </p><div></div><p><em><a href="https://www.ispor.org/heor-resources/good-practices/article/recommendations-on-the-use-of-structured-expert-elicitation-protocols-for-healthcare-decision-making" data-sf-ec-immutable=""></a></em></p><p><strong>Learning Objectives</strong></p><ul><li>Understand the importance of a strategy-led integrated evidence generation plan (IEGP) that aligns health economics and market access, patient-centered research, and real-world data and evidence to inform timely, cost-effective regulatory, HTA, and payer decisions from early development onward. </li><li><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;">Discern the patient experience data (PED) and direct-to-patient real-world data collection strategies that demonstrate unmet need and strengthen value narratives throughout the product lifecycle. </span></li><li>Explain how transparent, reproducible, and decision-grade economic and real-world evidence programs reduce uncertainty and enhance access outcomes in an expanded value framework environment. </li></ul><p> </p><p><strong>Moderator:</strong></p><p data-pm-slice="1 1 []"><strong>Mark Yates, MBChB (MD), PhD,</strong> Director of RWE strategy and RWD solutions, PPD Evidera Real World Data & Scientific Solutions, Thermo Fisher Scientific, London, United Kingdom</p><p><strong>Speakers:</strong><strong></strong></p><p data-pm-slice="1 1 []"><strong>Pedro Saramago Goncalves, MSc, PhD,</strong> Research Scientist, Consulting, PPD Evidera Health Economics and Market Access, Thermo Fisher Scientific, London, United Kingdom</p><p data-pm-slice="1 1 []"><strong>Sebastian Heidenreich, PhD, </strong>Executive Director, PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, London, United Kingdom</p><p data-pm-slice="1 1 []"><strong>Martin Parkinson, MRPharmS,</strong> Executive Director, EU HTA Regulation Lead Consulting, PPD Evidera Health Economics and Market Access, Thermo Fisher Scientific, London, United Kingdom<br /></p><br /><p><em>Sponsored by Corporate Partner, <a href="https://www.thermofisher.com/us/en/home.html" data-sf-ec-immutable="">Thermo Fisher Scientific</a>.</em><br /></p><em><img sf-image-responsive="true" src="/images/default-source/ispor-sponsored-content-logo/ispor-corporate-partner.png?sfvrsn=811bd2f_1" height="105" title="ispor-corporate-partner" width="115" alt="" sf-size="11595" /><br /><p></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></em>)