The challenge is built around a fully harmonized control-arm dataset drawn from 11 Alzheimer’s trials across five pharmaceutical sponsors: AstraZeneca, Lilly, Johnson & Johnson, Roche, and Takeda. It brings together 7,089 placebo-arm participants and more than 20 years of data — never before analyzed at this scale.
Three research tracks address questions newly answerable at this scale: sex differences in Alzheimer’s disease, rates of progression, and subtyping and heterogeneity. Up to 24 teams will participate, with $25,000 awarded to the first-place team in each track. Winning teams will also have the opportunity to publish findings in a high-impact journal and present at a major Alzheimer’s conference.
All analysis takes place within Vivli’s secure, cloud-based research environment. Teams must include a PI sponsor and a statistician at minimum.
The first letter of intent deadline is September 1, 2026. Winners will be announced in Spring 2027.
Date/Time: August 19, 2026 (9:00 AM ET | 3:00 PM CET)
Presenters: Jennifer O’Callaghan, Executive Director of Vivli Europe
The EU’s European Health Data Space (EHDS) Regulation establishes a framework for how health data can be accessed and reused to drive research, innovation, and policy. While the regulation entered into force in March 2025, its specific rules regarding the secondary use of data (SUD) are set to take effect in March 2029. In this session, Jennifer O’Callaghan, Executive Director of Vivli Europe, provides an introduction to the EHDS SUD mandate and its implications for both data holders and data users. She will examine the processes for making health data available for secondary use, highlight areas where the framework is still evolving, and address the key questions remaining as implementation begins.
No prior knowledge of EHDS is required; this session is designed for anyone seeking a clear overview of the EHDS SUD framework and its future trajectory.
Version 4.0 of the Vivli platform was released June 27, 2026 and is now available to users.
Release 4.0 includes several key improvements designed to enhance the user experience and support more secure, connected workflows:
Improved and updated platform navigation
Multi-Factor Authentication (MFA) enabled for all users to further enhance security
All Vivli resources and how to guides have been updated to reflect the latest release
“We are delighted to have added MFA to the Vivli platform to further enhance our security posture,” said Robert Conklin, Vivli Chief Technology Officer.
Global researchers used shared trial data to advance work in cancer, diabetes, and clinical trial design.
The Vivli Global Ambassador Program brought together a diverse group of researchers selected for their commitment to data transparency and leadership in advancing clinical research around the world.Through their use of shared clinical research data, these Ambassadors help promote responsible data sharing and reuse within their fields. Over the past year, the inaugural cohort has shown how data available through Vivli can be incorporated into active research programs to generate new findings, support scientific exchange, and create new opportunities for collaboration.One of the most important contributions of the program has been visibility. For many researchers, data reuse remains unfamiliar despite growing expectations around data sharing. Ambassadors helped bridge that gap by sharing their experiences at major scientific meetings and academic seminars across four continents, from the European Society for Radiation Oncology meeting in Vienna and the International Congress on Lung Cancer in Barcelona, to the Princess Takamatsu Symposium in Tokyo, the IATDMCT meeting in Singapore, and the Vivli Annual Meeting in Cambridge, Massachusetts. In each setting they discussed both the outcomes of their work and the practical realities of conducting secondary research, walking colleagues through everything from the data application process to study design, and introducing investigators across disciplines to approaches that are increasingly shaping the research landscape.What follows is a closer look at the work of the individual ambassadors.
Dr. David McAllister (University of Glasgow, Scotland) used Vivli individual participant data (IPD) to drive a productive year of diabetes and trial-methodology research, publishing four peer-reviewed papers in 2025. These included a network meta-analysis of age and sex differences in the efficacy of treatments for type 2 diabetes, published in JAMA, and an IPD meta-analysis of frailty across trials of glucose-lowering therapies, published in PLOS Medicine, alongside further work on trial representativeness and trial attrition. Beyond his own publications, Dr. McAllister presented on Vivli as a research resource at the universities of Bristol, Edinburgh, and Glasgow and at an EU doctoral training network, is supervising PhD students working directly with Vivli IPD, and drew on his established relationship with Vivli to strengthen several major grant applications and new institutional collaborations.
Dr. Jonas Saal (University Hospital Bonn, Germany) focused his ambassador year on immuno-oncology biomarkers, presenting Vivli-derived analyses of the modified Glasgow Prognostic Score (mGPS) and progressive-disease classification — including its use in selecting patients for treatment beyond progression — at oncology and urology meetings such as the DGHO annual meeting and the AIO Herbstkongress, where his work earned a Young Investigator Award. His written output included a review in the European Journal of Canceron sodium and immunotherapy and a Frontiers in Immunology article on mGPS in hepatocellular carcinoma, building on a body of Vivli-based publications spanning immunotherapy beyond progression, metastatic urothelial carcinoma, and metastatic renal cell carcinoma. He described Vivli as “an enabler of collaborative, methodologically rigorous secondary research.”
Dr. Youssef Zeidan (Baptist Health South Florida, USA) advanced his breast cancer research program through Vivli, completing a pooled analysis of the TRYPHAENA and NeoSphere trials examining radiation therapy in clinically node-positive, HER2-positive breast cancer. “The VIVLI Ambassador program provided an outstanding opportunity to support my ongoing breast cancer research initiatives,” he wrote. The findings were presented at the European Society for Radiation Oncology (ESTRO) annual meeting in Vienna and published in BMC Cancer. The project also became a mentorship opportunity: the trainee who led the analysis, a medical student, went on to match into radiation oncology at Stanford. Dr. Zeidan’s continued partnership with Vivli has since produced a newly approved project applying the same approach to triple-negative breast cancer.
Dr. Ashley Hopkins (Flinders University, Australia) drew on Vivli-accessed data to investigate how concomitant medicines and patient characteristics shape cancer outcomes, with written outputs including studies on concomitant medicines and patient-reported outcomes in chronic lymphocytic leukemia, a large-scale IPD meta-analysis of sex-based differences in solid-tumour outcomes (accepted in the Journal of the National Cancer Institute), and a breast-cancer outcomes paper led by a member of his team, Dr. Bradley Menz. Dr. Hopkins shared this work through an invited talk at IATDMCT 2025 in Singapore and an industry session on AI in oncology, while his engagement with the South Australian Comprehensive Cancer Network is now feeding directly into a new collaborative Vivli application on youth-onset cancers — and contributed to a PhD completion incorporating Vivli-derived work.
Dr. Diego Chowell (Icahn School of Medicine at Mount Sinai, USA) championed responsible data sharing within the AI and computational immuno-oncology community, weaving the case for transparent, well-governed clinical and trial datasets into talks on tumor evolution, immune recognition, and immunotherapy response prediction at Princeton University, the Princess Takamatsu Symposium in Tokyo, the International Congress on Lung Cancer in Barcelona, and a scientific seminar at VHIO. His central message, that robust, externally validated AI models depend on access to shared, reusable data, resonated with audiences of oncologists, computational biologists, and trialists. He is now developing a Vivli data request to externally validate his SCORPIO model for immune-risk prediction and trial stratification, laying the groundwork for a future Vivli-enabled analysis.
Dr. Marco Valgimigli (Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland) carried the case for responsible clinical-trial data sharing into the interventional cardiology and cardiovascular pharmacology community, anchored in his own Vivli-enabled work. As Lead Investigator of the PANTHER collaborative initiative — an individual patient data meta-analysis comparing P2Y12 inhibitor monotherapy with aspirin for secondary prevention in coronary artery disease, conducted using datasets accessed through Vivli and published in the Journal of the American College of Cardiology — he was able to present a completed, peer-reviewed project as a concrete proof of concept. He brought that example to talks and discussions at ESC Congress 2025 in Madrid, the inaugural EAPCI Summit 2026 in Munich, and FOKUS HERZ BERN 2026, and to direct engagement with trainees and collaborators at Cardiocentro Ticino, walking colleagues through the full arc of a Vivli data request to show how shared participant-level data enable rigorous, academically independent secondary research.
The influence of the program has also extended into the next generation of researchers. Through mentorship, collaboration, and the sharing of practical expertise, supervising doctoral students working with Vivli data, supporting trainees into competitive clinical positions, and seeding new multi-institutional projects, ambassadors have helped strengthen a growing community of investigators who view shared data as a resource for discovery. Their experiences provide examples that other researchers can learn from as they consider how existing datasets might contribute to their own work.
As the first year of the program concludes, the cohort’s accomplishments reflect a broader shift toward a research culture in which data are not only shared, but actively reused. Their work highlights the continued value of clinical research data and the new knowledge that can emerge when those data remain available to the scientific community.
Kaitlin Yee Research Coordinator, University of California San Francisco (UCSF) Department of Orthopaedic Surgery
Chronic low back pain affects one in five adults in the United States and remains one of the leading causes of disability worldwide. REACH, UCSF’s Core Center for Patient-Centric, Mechanistic Phenotyping in Chronic Low Back Pain, is funded through NIH HEAL and embedded within the Back Pain Consortium (BACPAC).
Established in 2019 with nearly $30 million in NIH funding, the Center runs two large observational cohorts with overlapping participant populations: comeBACK, an in-person study of 450 adults phenotyped across four University of California sites, and BACKHOME, a fully remote nationwide e-cohort of roughly 3,000 adults, the largest prospective remote registry of chronic low back pain to date. Between the two cohorts, there are nearly 3,450 participants.
Each cohort, along with the REACH center grant, had to be shared as its own data package, a condition of their federal funding. When NIH HEAL designated Vivli as its recommended repository, Kaitlin Yee, a Research Coordinator at UCSF’s Department of Orthopaedic Surgery, took on the submission process for all three.
“It was definitely a bit overwhelming at first,” Kaitlin said, “just in terms of where to start and exactly what was required of us.”
Each submission required four elements: a protocol, individual participant data (IPD), a data dictionary, and a statistical analysis plan. She started with Vivli’s submission checklist and a HEAL-specific tutorial video, which walked through each step, including how to connect each study’s DOI directly to the NIH HEAL Data Platform, so the data is findable from either direction.
“You can go to the HEAL platform and the DOI for our study is linked,” she said. “I thought that was actually pretty neat.”
Three submissions and dozens of files called for a system. The REACH team established a simple file naming convention that tied each data package to its corresponding publication, keeping the uploads organized across multiple cycles as the volume grew.
Kaitlin worked closely throughout the process with Sarah Sweet, Vivli’s Senior Clinical Research Manager. When a submission needed to be reset mid-upload, it was handled the same day.
“Sarah has been amazing. We’ve been talking back and forth ever since we started. She’s been so responsive. I really don’t think we’d be where we are without her.”
All three studies are now live on Vivli and linked to the HEAL Data Platform, making data from close to 3,450 participants available to researchers worldwide. For a condition that affects one in five adults and has long resisted easy answers, that reach is the payoff: every team that builds on this data gets closer to understanding chronic low back pain and how to treat it.
“We are excited to welcome Merck KGaA, Darmstadt, Germany to the Vivli platform,” shared Vivli CEO Rebecca Li. “Their membership meaningfully expands the data available to researchers and reflects the growing momentum behind responsible clinical trial data sharing.”
Founded in 1668, Merck KGaA, Darmstadt, Germany is the world’s oldest operating pharmaceutical and chemical company. Headquartered in Darmstadt, Germany, the company operates across three business sectors: healthcare, life science, and electronics — and has a presence in 66 countries. Its healthcare division focuses on developing therapies for difficult-to-treat conditions across disciplines such as oncology, neurology, and immunology. In the United States and Canada, the company’s healthcare business operates as EMD Serono.
For more information about the conditions for accessing Merck KGaA, Darmstadt, Germany data, please visit their member page. To learn more about membership in Vivli, visit our webpage.
In response to growing demand for secure, responsible clinical data sharing across Europe—and the increasing complexity of the evolving regulatory and research environment—Vivli has appointed Jennifer O’Callaghan as Executive Director of Vivli Europe, starting April 16, 2026.
Jennifer will lead the newly established Netherlands-based stichting (foundation), bringing deep expertise in clinical data sharing and the governance of responsible secondary use of clinical research data. Her experience spans roles as a research funder, advisor to multi-stakeholder consortia, and executive within global pharmaceutical organizations.
Leading the European organization, Jennifer will shape strategy and engage partners to enable greater access to high-quality data for researchers across Europe. She will ensure that activities align with the region’s regulatory frameworks and drive initiatives to expand collaboration among industry, academia, and policymakers.
“Europe is at a pivotal moment for clinical research data sharing, and Jennifer brings a rare depth of knowledge in this rapidly evolving field,” said Vivli’s Chief Executive Officer, Rebecca Li. “Strong regional leadership is critical as we accelerate research and expand access to trusted data that can improve patient outcomes. Jennifer’s leadership will be instrumental in advancing Vivli’s mission, scaling impact, and strengthening partnerships across the region.”
Jennifer has been involved with Vivli for over a decade, serving on the foundational working group that established high standards for patient privacy, governance, and transparency while fostering collaboration across pharma, biotech, academia, and the research community to produce new insights.
“At a time of surging demand for data, Europe faces the dual challenge of increasingly complex regulation and the need to balance patient privacy with responsible data innovation, including AI,” said Jennifer O’Callaghan, Executive Director of Vivli Europe. “Vivli Europe will play a central role in meeting this challenge through responsible data sharing in compliance with EU legislation.”
Global research is accelerating, and trusted, compliant data sharing in Europe has never been more complex or essential. To advance collaboration, on March 10, 2026, Vivli expanded its global footprint by establishing Vivli Europe, an independent Netherlands-based Stichting (i.e., Foundation) in Amsterdam.
“Vivli empowers researchers and accelerates medical discoveries through secure, responsible data sharing. Vivli Europe will foster deeper partnerships and create new opportunities for investigators to access and analyze high-quality datasets,” stated Rebecca Li, CEO of Vivli.
Vivli has spent over a decade developing a global network of researchers, data contributors, funders, and institutions to deliver more support for cross-border research. Vivli Europe will continue this trajectory of collaboration and integration.
Establishing Vivli Europe enables alignment with European partners, research, and policy, including the European Health Data Space (EHDS), and engagement in regional initiatives and consortia.
“The establishment of Vivli Europe reflects both the growing importance of cross-border data sharing and the leadership role Europe is playing in shaping its future. Vivli is well positioned to contribute to this evolving landscape by enabling responsible access to data that drives new scientific insights and improves health outcomes worldwide,” said Vivli Board Chair, Steve Kern.
Vivli’s mission remains global, supporting researchers and partners with transparency, integrity, and impact.
The next phase will be announced shortly, discussing the next milestone and initiatives.
Vivli is pleased to announce that Steven E. Kern, PhD, will serve as the new Chair of its Board of Directors succeeding Michael Stebbins. Dr. Kern has been a valued member of Vivli’s Board and brings more than three decades of experience spanning academia, global health, and the pharmaceutical industry.
Dr. Kern most recently served as Executive Director of Global Health Labs, a Gates Ventures initiative focused on developing diagnostic and healthcare technologies for low- and middle-income countries. Prior to that, he was Deputy Director of Quantitative Sciences at the Bill & Melinda Gates Foundation. His academic career included nearly 15 years as Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering at the University of Utah, where he led clinical pharmacology research across diverse populations ranging from preterm infants to elderly adults.
Dr. Kern has long been an advocate for open, accessible research data and brings deep expertise in data-driven drug development and global health innovation. As Board Chair, he will help guide Vivli’s continued growth as a global leader in clinical research data sharing.
“Steve has been a tremendous asset to Vivli’s Board, and we are delighted that he will now serve as our next Chair,” said Rebecca Li, CEO of Vivli. “His experience across global health, pharmaceutical research, and data science aligns closely with Vivli’s mission. We look forward to working closely with him as we expand access to data and enable new scientific insights worldwide.”
Version 3.9 of the Vivli platform was released February 28th, 2026 and is now available to users. Highlights of the release include:
Updated Organization Administrator Dashboard: Organization Administrators now have an improved dashboard showing Data Requests, Publications, Data Upload, and Enquiries awaiting their action. Dashboard information can also be downloaded.
Multi-Factor Authentication: Multi-factor authentication for user login is being rolled out over the coming weeks. Users will receive an email before this is activated on their account.
Data Request Form Enhancements: Users can now download the data request form, compare different versions of the form as a PDF as part of the version history of a request, and remove a research team member while a request is in draft.
Data Request Summary Report: A new report of the Data Request Summary is available for your team to access at any time.
All Vivli resources and how to guides have been updated to reflect the latest release
“Vivli is delighted to provided additional benefit to our users, which we have prioritized enhancing these features based upon their feedback,” said Julie Wood, COO Vivli. “We would encourage all users to sign up to provide feedback so we can continue to improve the platform to meet their needs”
Researchers can complete the form below to sign up and take part in user interviews.
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