Tokenization in Clinical Trials: Benefits and End-to-End Enablement

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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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

Tokenization in Clinical Trials: Benefits and End-to-End Enablement

December 5, 2023

<a href="/education-training/webinars">Back to all webinars</a><h4>Open to all ISPOR Members and Non-members</h4> Title: Tokenization in Clinical Trials: Benefits and End-to-End EnablementTuesday, December 5, 2023 11:00AM EST | 4:00PM UTC | 5:00PM CET <a href="https://www.timeanddate.com/worldclock/fixedtime.html?msg=Tokenization+in+Clinical+Trials%3A+Benefits+and+End-to-End+Enablement&iso=20231205T11&p1=179&ah=1" data-sf-ec-immutable="">Click here for time zone conversion</a><br="" <="" p=""> <a href=" https://portal.ispor.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=c0150fca-83f5-4a2c-9994-82c982c47b78&RegPath=EventRegNoFees&FreeEvent=1&Event=ISPOR%20Webinar:%20Tokenization%20in%20Clinical%20Trials:%20Benefits%20and%20End-to-End%20Enablement&FundraisingEvent=0&evt_guest_limit=0 " class="button primary" data-sf-ec-immutable="" target="_blank">Register Now</a></br=""> <p=""> Description</p=""> <div>Tokenization allows linking of disparate deidentified datasets in a privacy preserving and compliant manner. It provides an opportunity to assess real-world, long-term outcomes of clinical trial subjects beyond their clinical trial participation as well as link electronic health records (EHRs), claims, and registry data. Tokenizing and linking real-world data (RWD) sets can create more robust and relevant data to support regulatory and payer decision-making. This webinar will provide a brief background on tokenization and its benefits. It will focus on end-to-end considerations for tokenizing data of clinical trial participants and designing fit for purpose studies based on linked real-world datasets. This webinar will outline (i) criteria for selecting clinical trials suitable for tokenization, (ii) highlight operational and evidence generation complexities and present potential options at various steps needed before, during, and after the clinical trial to enable tokenization, (iii) elucidate how to create and use linked datasets to derive fit for purpose real world evidence. Datasets obtained by linking patient level data from clinical trials with external datasets have unique characteristics and pose varying challenges. This webinar will help provide a key understanding of these challenges and provide potential solutions to overcome them.The audience will get an overall understanding and introduction to using tokenization related to clinical trials, which can inform linking clinical trial dates to RWD in their organization. An interactive discussion between the presenters will provide an opportunity to delve deeper into select issues and approaches in enabling tokenization and how to best derive fit-for-purpose evidence for multiple stakeholders.  </div><div>Learning Objectives</div><ul><li>Understand tokenization, its benefits and applicability, including, how tokenization can be used to follow clinical trial participants in the real world.</li><li>Gain an understanding of the key considerations and steps needed to tokenize clinical trials, including necessary interactions with clinical trial sites.</li><li>Understanding of how to create linked datasets and how to leverage it for generating fit for purpose RWE with appropriate study designs. </li></ul> Speakers: Kaustuv Bhattacharya, MS, PhD, Assistant Professor of Pharmacy Administration and Research Assistant Professor in the Center for Pharmaceutical Marketing and Management, University of Mississippi School of Pharmacy, Oxford, MS, USAAkshay Vashist, PhD, Head, Medical and Real-World Data Analytics, Otsuka Pharmaceutical Development and Commercialization (OPDC) Inc., Princeton, NJ, USAAmit Kulkarni, PhD, Head, Health Economics and Decision Sciences, Otsuka Pharmaceutical Development and Commercialization (OPDC) Inc., Princeton, NJ, USA<div>Kathleen Gavin, PhD, Clinical Trials Scientific Lead, Datavant, Kansas City, MO, USA</div><div> </div> Brought to you by: <a href="/member-groups/special-interest-groups/real-world-evidence-(rwe)">ISPOR Real-World Evidence Special Interest Group</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

Tokenization in Clinical Trials: Benefits and End-to-End Enablement

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

More...

Shaking the Myth of Real-World Evidence

Additional Resources

Conferences & Summits

December 5, 2023

Short Courses & Webinars

December 5, 2023

The Professional Society for
Health Economics and Outcomes Research

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