November 8: Getting Closer to the Target: Practical Strategies to Hit the Mark in Trial Emulation

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...

Value in Health 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.

Download the Report

ISPOR/ISPE Joint Real-World Evidence Transparency Position Statement

ISPOR—The Professional Society for Health Economics and Outcomes Research and the International Society for Pharmacoepidemiology (ISPE) have published a joint position statement on real-world evidence transparency.

View the Statement

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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Go To The Registry

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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.

View Webinar

Download Slides

Additional Resources

Real-World Evidence Transparency Statement [ISPOR/ISPE]
Real-World Evidence Registry
Good Practices Reports and Other ISPOR Reports from Value in Health
"Unlocking the Promise of Real-World Evidence" (Value & Outcomes Spotlight, Vol. 6, No. 5)
ISPOR's Real-World Evidence Strategic Initiatives

Conferences & Summits

November 8: Getting Closer to the Target: Practical Strategies to Hit the Mark in Trial Emulation - In Person at ISPOR Europe 2026

November 8, 2026

<div><h4 data-start="54" data-end="108"><strong data-start="54" data-end="108">Design target trial emulation studies for high-quality real-world evidence generation</strong></h4><p data-start="175" data-end="573">This course introduces the principles and practical application of target trial emulation (TTE) for generating robust real-world evidence. Participants learn how to design fit-for-purpose studies by aligning key design elements, minimizing common sources of bias, and applying methodological best practices for external control arms, hybrid trial designs, and other observational research settings.<br /></p><p data-start="575" data-end="604"><strong data-start="575" data-end="604">Technical topics include:</strong></p><ul data-start="606" data-end="936"><li data-section-id="gfo4zj" data-start="606" data-end="673">Core principles of target trial emulation and causal study design </li><li data-section-id="k9ku1u" data-start="674" data-end="745">Selection of eligibility criteria, index dates, and follow-up periods </li><li data-section-id="xdfsxu" data-start="746" data-end="848">Common time-related biases, including immortal time bias, left truncation, and informative censoring </li><li data-section-id="187ssj" data-start="849" data-end="936">Strategies for confounding control, including approaches for time-varying confounding </li></ul><p data-start="938" data-end="1025"><strong data-start="938" data-end="1025">This course includes tools and concepts that can be immediately applied, including:</strong></p><ul data-start="1027" data-end="1396"><li data-section-id="jdh3dl" data-start="1027" data-end="1098">A structured decision framework for selecting appropriate index dates </li><li data-section-id="syj2s6" data-start="1099" data-end="1172">Practical approaches for designing credible, decision-ready TTE studies </li><li data-section-id="1r97ufv" data-start="1173" data-end="1273">Interactive case studies demonstrating the impact of study design decisions on real-world evidence </li><li data-section-id="fdjzqm" data-start="1274" data-end="1396">Interpretation of survival curves, hazard ratios, covariate balance, and weighting diagnostics to evaluate study quality</li></ul><div>By integrating conceptual guidance with hands-on application, this course equips researchers, regulators, and decision-makers with practical tools to operationalize TTE principles and generate credible, transparent, and defensible RWE across therapeutic areas.</div><div fontscheme-block="2"><br /></div><div><strong fontscheme="2">PREREQUISITES:</strong> Basic familiarity with observational research and real-world data. Prior exposure to causal inference concepts is helpful but not required.</div><div></div><ul data-start="706" data-end="964"></ul><p data-start="54" data-end="127"><span style="background-color:initial;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;caret-color:auto;white-space:inherit;"><a class="button primary" href="/conferences-education/conferences/upcoming-conferences/ispor-europe-2026/program/program/">Register Here</a></span></p></div><p>*Conference attendance is not required to attend an ISPOR Short Course. Separate registration is required for conference attendees.<strong></strong></p><table><tbody><tr><td style="border:none;" ;="" width="20%"><figure class="image"><img src="https://portal.ispor.org/eWeb/fileviewer.aspx?itemkey=D882CFA3-986F-455B-A15A-B0630C9B2BBC&objectName=co_document&file=6-epidemiology-99a66b82.png" width="100" height="100" /></figure></td><td style="border:none;"><p><strong>LEVEL:</strong> Intermediate<br /><strong>TRACK:</strong> Real-World Data & Information Systems <br /><strong>HEOR Competency:</strong> 6.1 Epidemiology, Including Pharmacoepidemiology Studies<br /><a target="_blank" href="/docs/default-source/heor-resources-documents/ispor-heor-competencies.pdf?sfvrsn=edc1660a_11">HEOR Competencies: A resource for HEOR Professionals</a></p></td></tr></tbody></table><p><strong>FACULTY MEMBERS</strong><strong></strong></p><div><strong fontscheme="2">Neisha Opper, PhD, MPH </strong></div><div>Director of Epidemiology</div><div>Landmark Science, Inc.</div><div>Los Angeles, CA, USA</div><div fontscheme-block="2"><br /></div><div><strong fontscheme="2">Shivani S. Aggarwal, PhD, MS </strong></div><div>CEO </div><div>Landmark Science, Inc.</div><div>Los Angeles, CA, USA</div><div fontscheme-block="2"><br /></div><div><strong fontscheme="2">Hoa Le, PhD, MD</strong></div><div>Assistant Professor</div><div>The University of North Carolina at Chapel Hill</div><div>Chapel Hill, NC, USA</div><div fontscheme-block="2"><br /></div><div><strong fontscheme="2">Jennifer B. Christian, PharmD, MPH, PhD, FISPE</strong></div><div>Senior Clinical Advisor </div><div>GDIT</div><div>Durham, NC, USA</div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div><div></div><div></div><div></div><div></div><div></div><div></div><div></div><div><div></div><p><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><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><p><strong>LENGTH:</strong> 4 Hours | Course runs 1 day</p></div><div><p><strong><strong>Sunday, 8 November 2026 | Course runs 1 Day<br /></strong></strong>8:00am-12:00pm Central European Time (CET)<span style="background-color:transparent;color:#999999;font-family:inherit;font-size:10px;text-align:inherit;text-transform:uppercase;word-spacing:normal;caret-color:auto;white-space:inherit;"></span><br /></p></div><a class="button primary" href="/conferences-education/conferences/upcoming-conferences/ispor-europe-2026/program/program/">Register Here</a> <p>*Conference attendance is not required to attend an ISPOR Short Course. Separate registration is required for conference attendees.</p><strong></strong><p><a target="_blank" href="/conferences-education/conferences/upcoming-conferences/ispor-europe-2026">Visit the ISPOR Europe 2026 Program page to view all short courses offered.</a></p><strong></strong><p><a href="/education-training/short-courses">Back to all short courses</a></p></div>)

Short Courses & Webinars

November 8: Getting Closer to the Target: Practical Strategies to Hit the Mark in Trial Emulation - In Person at ISPOR Europe 2026

Real-World Evidence Transparency Initiative

A partnership between ISPOR, the International Society for Pharmacoepidemiology, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council

Establishing a Culture of Transparency for Real-World Evidence Studies...

Improving Transparency to Build Trust...

More...

ISPOR/ISPE Joint Real-World Evidence Transparency Position Statement

Real-World Evidence Registry

More...

Shaking the Myth of Real-World Evidence

Additional Resources

Conferences & Summits

November 8, 2026

Short Courses & Webinars

November 8, 2026

ISPOR–The Professional Society for
Health Economics and Outcomes Research

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