Revolutionizing Clinical Trials

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.

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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.

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Additional Resources

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

Revolutionizing Clinical Trials: Harnessing Real-World Evidence to Drive Diversity and Clinical Implementation

April 10, 2024

<a href="/education-training/webinars">Back to all webinars</a><h4>Open to all ISPOR Members and Non-members</h4> Title: Revolutionizing Clinical Trials: Harnessing Real-World Evidence to Drive Diversity and Clinical Implementation Wednesday, April 10, 2024 11:00AM EDT | 3:00PM UTC | 5:00PM CEST<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><a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=Revolutionizing+Clinical+Trials&iso=20240410T11&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion </a> <a href=" https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=af64692d-9120-4a2c-8de4-0a1b4a46e87e&RegPath=EventRegNoFees&FreeEvent=1&Event=ISPOR%20Webinar:%20Revolutionizing%20Clinical%20Trials:%20Harnessing%20Real-World%20Evidence%20to%20Drive%20Diversity%20and%20Clinical%20Implementation&FundraisingEvent=0&evt_guest_limit=0" class="button primary" data-sf-ec-immutable="" target="_blank">Register Now</a> <p="">Description</p=""> Join us as we explore the ever-changing intersection of real-world evidence (RWE) and clinical trials. In this session, we'll discuss leveraging RWE to enhance diversity within clinical trials and expedite the translation of research findings into real-world clinical practice. Our expert panel will illuminate how RWE can address existing disparities in clinical trial participation, amplify the voices of underrepresented communities, and ultimately lead to more effective and equitable healthcare interventions.<div><p=""><p=""> Learning Objectives<ul><li>Explore the transformative potential of real-world evidence (RWE) in enhancing clinical trial design and execution. </li><li>Discuss cutting-edge technologies shaping the future of clinical research from Natural Language Processing (NLP) to AI-driven analytics. </li><li>Identify practical strategies for integrating RWE and technology to optimize trial efficiency and outcomes.</li></ul></p=""> </p=""> </div><div>Moderator:Myla Maloney, MBA, BCMAS, Chief Growth Officer, PINC AI Applied Sciences, a Division of Premier, Charlotte, NC, USA<div>Speakers: Vani Nilakantan, PhD, System Vice President of Research, CommonSpirit Research Institute, The Colony, TX, USAChad Adams, MPH, Associate Vice President of Research, HonorHealth; Chief Operational Officer, HonorHealth Research Institute, Scottsdale, AZ, USAAnhaita Jamula, CCRC, Director of Research, EvergreenHealth, Kirkland, WA, USA <div>Brought to you by: <a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.pinc-ai.com%2fapplied-sciences%2fmedical-device%2f&c=E,1,-4t0ZEON8cRuHXLBfl8RhOfbi4D8MVo2P9jitLx6IRUUFv7c71uahN2nc88L1xr4UgpsHvjePi72UKWoC42XD0qVImvNNPfyYEiFQ2adRPkcJPHk3jK9NA,,&typo=1" data-sf-ec-immutable="">PINC AI™ Applied Sciences, a Division of Premier</a></div></div></div><a href="https://fifarma.org/" data-sf-ec-immutable=""></a><a href="https://www.lcp.com/health/" data-sf-ec-immutable="" data-sf-marked=""></a> 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" rel="noopener noreferrer" target="_blank">ISPOR Educational Webinar Series webpage</a> approximately 2 days after the scheduled Webinar.<div>Reservations are on a first-come, first-served basis.</div>)

Short Courses & Webinars

Revolutionizing Clinical Trials: Harnessing Real-World Evidence to Drive Diversity and Clinical Implementation

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...

Real-World Evidence Registry

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Shaking the Myth of Real-World Evidence

Additional Resources

Conferences & Summits

April 10, 2024

Short Courses & Webinars

April 10, 2024

ISPOR–The Professional Society for
Health Economics and Outcomes Research

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