GARDP Joins Vivli as New Member to Share its Data

October 5, 2026

“We are delighted to welcome the Global Antibiotic Research & Development Partnership (GARDP) as a member of Vivli and Vivli’s AMR Register” shared Rebecca Li, Vivli CEO. “GARDP’s leadership in addressing antimicrobial resistance makes its commitment to data sharing especially significant. We look forward to working together to broaden access to valuable clinical research data and to support the evidence needed to develop effective treatments for drug-resistant infections.”

“Antimicrobial resistance is a global challenge that demands collaboration and transparency across the research ecosystem,” said Justin Green, Medical Director at GARDP. “Through our participation in Vivli and the AMR Register, GARDP is reinforcing its commitment to responsible data sharing and to advancing the science needed to deliver new treatment options for drug-resistant infections. We hope the data will support researchers worldwide and help ensure that effective treatments reach the people who need them most.”

GARDP is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. Its public-private partnership model integrates affordability, appropriate use, and sustainable access throughout the development process, with a particular focus on high-burden countries and vulnerable populations, including newborns.

By joining Vivli and participating in Vivli’s AMR Register, GARDP will help expand access to clinical research data and strengthen the global evidence base for addressing antimicrobial resistance.

For more information about the conditions for accessing GARDP data, please visit their member page. To learn more about membership in Vivli, visit vivli.org/members/become-a-member/ .

What Shared Research Data Reveals About Treating Atrial Fibrillation

September 30, 2026

Knowing that a treatment is effective does not always settle the question of who should receive it.

For people with atrial fibrillation (AFib), care often goes beyond managing the irregular heart rhythm that characterizes the condition. AFib can cause blood to pool in the heart and form clots that may travel to the brain, increasing the risk of stroke. It can also impair the heart’s ability to pump effectively, contributing to an increased risk of heart failure.

Preventing these complications is central to treatment, but doing so involves trade-offs. Anticoagulants, commonly known as blood thinners, can reduce the likelihood of a stroke while increasing the potential for serious bleeding. Which way that balance tips depends on the individual patient, and predicting it reliably can be difficult.

September’s Atrial Fibrillation Awareness Month brings attention to these challenges in clinical decision-making, while also offering an opportunity to examine how researchers are strengthening the evidence used to address them. Through Vivli, research teams can access anonymized participant-level data from completed clinical studies and examine the relationships among patients’ clinical histories, treatments and outcomes in greater detail. The studies that follow, each drawing at least in part on data accessed through Vivli, show how that level of detail can inform questions about who should receive treatment and when.

Clinicians deciding whether to prescribe an anticoagulant often use a point-based score to estimate a patient’s stroke risk. Factors such as age, high blood pressure and a previous stroke contribute to the total, with some carrying more weight than others. For years, the widely used CHA₂DS₂-VASc score also assigned one point for female sex, allowing women to reach the treatment threshold sooner than men with otherwise similar clinical histories.

In 2024, European guidelines adopted a revised score that removed sex as a criterion, citing large-scale national studies showing that the gap in stroke rates between women and men had narrowed. Steven Lam, Gregory Lip and colleagues at the University of Liverpool examined how the revised score performed using records from 21,260 patients in the GLORIA-AF registry, accessed through Vivli. They found that the score without the sex criterion predicted stroke and other clot-related events about as well as its predecessor, supporting the shift to a simpler tool.

The analysis also highlighted sex-based differences in care that may warrant attention as the revised guidance is adopted. After accounting for the other factors in the score, the research team found that women were slightly less likely than men to receive anticoagulants, and that untreated women had a higher risk of ischemic stroke at one year. Because the data predated the guideline change, the study cannot show how the revised score will affect prescribing. It does provide a baseline for measuring that effect, and a reason to keep sex-based differences in care in view as the new score comes into use.

Decisions about anticoagulation become more complicated after an intracranial hemorrhage, or bleeding inside the skull. Treatment is typically stopped to reduce the risk of further bleeding, but randomized evidence on whether and when to restart it has been limited. Using participant-level data from four randomized trials, including one accessed through Vivli, Rustam Al-Shahi Salman and colleagues at the University of Edinburgh assessed the benefits and risks of resuming treatment in 412 people with AFib who had experienced this type of bleeding.

Their research found that people who restarted a blood thinner after a brain bleed were about 70 percent less likely to have a stroke, heart attack or other clot-related event than those who did not. In other words, staying off the drug carried a clear risk: 19 percent of untreated patients had one of these events, compared with 4 percent of treated patients. The risk of serious bleeding after restarting was less clear. It occurred in 7 percent of patients who restarted treatment and 5 percent of those who did not, but there were too few events to confirm an increased risk or rule out a substantial one. Taken together, the findings show that withholding treatment carries risks for people with AFib, but they do not establish whether restarting it improves survival or independence. That leaves a clearer question for future research: which patients gain enough protection from clots to outweigh the risk of another bleed?

Knowing that a treatment works does not settle who should receive it. That question has thousands of answers, one for each patient whose age, history and circumstances shift the balance between the harm a drug prevents and the harm it can cause. Clinicians are better equipped to weigh those differences when the evidence behind them has been built at scale. During Atrial Fibrillation Awareness Month, Vivli is proud to contribute to this growing body of research and to continue our mission of making data accessible to move the field forward.

Publications and public disclosures on atrial fibrillation using Vivli-hosted data

Stroke risk stratifications according to CHA₂DS₂-VASc vs. CHA₂DS₂-VA in patients with atrial fibrillation: insights from the GLORIA-AF registry European Heart Journal – Cardiovascular Pharmacotherapy | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Effects of oral anticoagulation in people with atrial fibrillation after spontaneous intracranial haemorrhage (COCROACH): prospective, individual participant data meta-analysis of randomised trials The Lancet Neurology | PI: Rustam Al-Shahi Salman, University of Edinburgh | Data Request 7581

Long-term clinical outcomes of oral anticoagulation in the older patients with atrial fibrillation aged 80 years: a report from the GLORIA-AF registry phase III Age and Ageing | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Cardio-kidney-metabolic complexity in patients with atrial fibrillation: an analysis from the prospective GLORIA-AF registry phase III Cardiovascular Diabetology | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Long-term risks and benefits of oral anticoagulation in atrial fibrillation patients with cancer European Journal of Clinical Investigation | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Residual Risks of Thrombotic Complications in Anticoagulated Patients with Atrial Fibrillation: A Cluster Analysis Approach from the GLORIA-AF Registry Journal of General Internal Medicine | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Diabetes mellitus and adverse clinical events in patients with atrial fibrillation: A report from the GLORIA-AF registry phase III Diabetes, Obesity and Metabolism | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Combination therapy of beta-blockers and digoxin is associated with increased risk of major adverse cardiovascular events and all-cause mortality in patients with atrial fibrillation Internal and Emergency Medicine | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants Circulation | PI: Changyu Shen, Beth Israel Deaconess Medical Center | Data Request 3876

Clinical outcomes of anticoagulated patients with atrial fibrillation after falls or head injury: insights from RE-LY Stroke | PI: Daniel Caldeira, University of Lisbon | Data Request 5294

Adherence to the Atrial Fibrillation Better Care (ABC) pathway and the risk of major outcomes in patients with atrial fibrillation eClinicalMedicine | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation eClinicalMedicine | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Sex as a Risk Factor for Atrial Fibrillation-Related Stroke Thrombosis and Haemostasis | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Implications of Clinical Risk Phenotypes on the Management and Natural History of Atrial Fibrillation Journal of the American Heart Association | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Clinical Outcomes in Metabolically Healthy and Unhealthy Obese and Overweight Patients With Atrial Fibrillation Mayo Clinic Proceedings | PI: Gregory Y.H. Lip, University of Liverpool | Data Request 7074

Principled estimation and evaluation of treatment effect heterogeneity: A case study application to dabigatran for patients with atrial fibrillation Journal of Biomedical Informatics | PI: Nigam Shah, Stanford University | Data Request 6716

Integrated Machine Learning Decision Tree Model for Risk Evaluation in Patients with Non-Valvular Atrial Fibrillation When Taking Different Doses of Dabigatran International Journal of Environmental Research and Public Health | PI: Yung-Chuan Huang, Fu Jen Catholic University Hospital | Data Request 6732

Meet the 2026 Vivli Global Ambassadors

August 25, 2026

Vivli is pleased to announce the 2026 cohort of Global Ambassadors, a group of researchers using shared clinical research data to answer important scientific questions and champion the value of data reuse within their research communities. The Global Ambassador Program supports researchers in extending the reach and impact of work emerging from secondary analyses. Ambassadors share their findings and perspectives through conferences, publications, professional networks, and other forums, contributing to broader conversations about responsible data sharing and reuse. “We are excited to welcome this new group of Ambassadors and support them in sharing both their research and their experiences working with shared data,” said Rebecca Li, Vivli CEO. “Researchers who put existing data to new use are some of the strongest advocates for data sharing because they can show firsthand the new questions, findings, and collaborations that access can make possible.”

**Dr. Ruanne Barnabas** Massachusetts General Hospital, USA

**Dr. Diego Chowell** Icahn School of Medicine at Mount Sinai, USA

**Robin Gal** Jaeb Center for Health Research

**Dr. Ashley Hopkins** Flinders University, Australia

**Dr. Jennifer Lees** University of Glasgow, Scotland

**Dr. David McAllister** University of Glasgow, Scotland

**Dr. Stephen Opiyo** The Ohio State University

**Dr. Vivek Rudrapatna** University of California, San Francisco

**Dr. Jonas Saal** University Hospital Bonn, Germany

**Dr. Marco Valgimigli** Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland

**Dr. Youssef Zeidan** Baptist Health South Florida, USA

The 2026 cohort builds on the work of Vivli’s inaugural Ambassadors, who used data accessed through Vivli to advance research across cancer, cardiovascular disease, diabetes, and clinical research methodology. Over the course of the year, the 2025 Ambassadors published new findings, presented their work to research communities around the world, pursued new analyses, and helped broaden the conversation around responsible data sharing and reuse. We congratulate this year’s Ambassadors on their selection and look forward to following their work over the coming year.

The Second Life of Clinical Research Data

August 13, 2026

Decisions made during study design have a lasting impact and shape the evidence the research yields.

Patterns may arise across multiple studies that are difficult to discern in individual results. Aggregating participant-level data across multiple studies enables researchers to understand how analytical methods selection, trial conduct, and design characteristics can impact research outcomes. These learnings can uncover new insights and improve future research, extending the value of existing data and patient contributions.

Vivli provides the secure access that makes this kind of inquiry possible. Researchers can draw on anonymized participant-level data from completed studies to investigate questions beyond the aims of the original work, extending the value of the data and participants’ contributions.

When those data span thousands of participants, researchers can pursue queries like:

Why do participants leave a study early? Can control data collected earlier be used again without weakening the analysis? Which statistical methods give the clearest picture of treatment effects?

The studies below show how Vivli supports efforts to answer these questions.

When participants leave a study early, the resulting gaps can weaken the evidence and complicate its interpretation. Ryan McChrystal, David McAllister, and colleagues at the University of Glasgow analyzed participant-level data from 90 randomized studies involving 86,107 people across 10 conditions. By tracing when participants left and the reasons reported for their departure, the team found that attrition was generally highest near the beginning of follow-up and was most often associated with adverse events or voluntary withdrawal. The scale of the analysis made it possible to show that attrition changes over time and differs by cause, giving teams a more precise basis for anticipating where losses are most likely to occur. Those patterns can inform enrollment targets, the timing of retention efforts, and how incomplete follow-up is handled in the final analysis.

Article content — Dropout risk over time by reported cause, from 90 randomized studies. Each line is one trial; colors show the best-fitting statistical model. Adapted from McChrystal et al., J Clin Epidemiol 2025 (CC BY 4.0).

Control groups raise a different methodological question. In studies that add treatments over time, control participants enrolled earlier may differ from those enrolled alongside a later treatment group. Using the earlier data could reduce the number of new control participants needed, but changes in who enrolls or how care is delivered can skew the comparison. Junichi Asano, Akihiro Hirakawa, and colleagues at the Institute of Science Tokyo, developed a Bayesian method that determines how much influence the earlier control data should have. They tested it through simulations and applied it to COVID-19 data accessed through Vivli. When results from the earlier and concurrent control groups were similar, the method gave the earlier data more weight. When they differed, it gave them less. The approach can make better use of existing controls while limiting the chance that changes over time are mistaken for a treatment effect.

The same need for careful judgment extends to the analysis of patient-reported outcomes. Jiajun Yan, Feng Xie, and colleagues at McMaster University examined whether the statistical method used to analyze EQ-5D, a widely used measure of health and quality of life, could change the estimated effect of a treatment. Previous guidance had rested largely on simulation studies and expert recommendations. Using participant-level data from 13 completed studies, the team applied four common models to each dataset separately and compared the results. The models generally reached the same conclusion about whether a treatment made a meaningful difference. This suggests that, in many cases, the overall interpretation did not depend heavily on the method chosen. However, the comparison also showed where the methods began to diverge when many responses were missing or clustered at the top of the scale. In those cases, the choice of analysis could shape the result. These findings give researchers a firmer basis for analyzing quality-of-life outcomes in future work.

Shared data makes it possible to examine the decisions that shape clinical research with the same rigor used to study treatments and outcomes. By revisiting data from completed studies, investigators can trace how decisions made during design and analysis influence the findings. Vivli gives this data a continuing life, allowing knowledge to build from one study to the next.

Recent methodology and prediction publications and public disclosures using Vivli-hosted data

Modeling rates of trial attrition: an analysis of individual participant data from 90 randomized controlled trials of pharmacological interventions for multiple conditions Journal of Clinical Epidemiology| PI: David McAllister, University of Glasgow | Data Request 9492

Bayesian Power Prior in Platform Trials With Non-Concurrent Control for Binary Outcomes Statistics in Medicine| PI: Akihiro Hirakawa, Tokyo Medical and Dental University | Data Request 9907

An Empirical Comparison of Statistical Methods for Estimating Treatment Effects on EQ-5D in Randomized Clinical Trials Value in Health| PI: Jiajun Yan, McMaster University | Data Request 9253

Estimating hypothetical estimands with causal inference and missing data estimators in a diabetes trial case study Biometrics| PI: Johnathan Bartlett, London School of Hygiene & Tropical Medicine | Data Request 6764

Statistical Modeling to Adjust for Time Trends in Adaptive Platform Trials Utilizing Non-Concurrent Controls Biometrical Journal| PI: Günter Höglinger, Hannover Medical School | Data Request 6495

Assurance Methods for Adaptive Clinical Trials with a Delayed Treatment Effect White Rose eTheses Online| PI: James Salsbury, University of Sheffield | Data Request 9422

Introducing the Alzheimer’s Trials Data Discovery Challenge

July 21, 2026

We are proud to announce the launch of the Alzheimer’s Trials Data Discovery Challenge — a $75,000 research competition powered by the Alzheimer’s Disease Data Initiative and Vivli, and supported by Alzheimer’s Research UK.

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.

Learn more and apply →

Vivli Platform Version 4.0 Now Available

June 29, 2026

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.

The Vivli Global Ambassador Program: Highlights from the Inaugural Cohort

June 4, 2026

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 Cancer on 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.

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.

Beyond the Study: How Shared Data Is Advancing Inflammatory Bowel Disease (IBD) Care

May 22, 2026

For patients living with IBD, the two main types being Crohn’s disease or ulcerative colitis (UC), finding the right treatment is rarely a straight line.

Despite a growing number of effective therapies, clinicians face unresolved questions; which patients will respond to a given treatment, and how should we track progress? Through platforms like Vivli, investigators can access anonymized individual participant-level data from completed clinical research and use it to generate new evidence to advance understanding of IBD progression and improve treatment approaches.

Data used in these studies was made possible through Vivli’s data sharing platform, spanning a range of questions working to advance the field of IBD care.

Significant findings have emerged from researchers looking across multiple studies. By pooling individual patient-level data, Vipul Jairath and his team from Alimentiv found that placebo response rates vary significantly across UC trials. The same research group also examined how patient age affects the efficacy and safety of advanced therapies during induction in UC, finding that trial populations do not always reflect the broader, more complex patients seen in everyday practice. Knowing where evidence holds and where it has limits allows clinicians to apply it more appropriately.

Other work is tackling one of the more consequential problems in IBD care: identifying in advance which patients will respond to a given therapy. Neeraj Narula and colleagues at Hamilton Health Sciences found that eosinophil levels in blood and tissue predict which UC patients are likely to benefit from mirikizumab, a biologic therapy. For patients who have cycled through multiple treatments without success, a reliable predictor of response before starting therapy could mean the difference between months of ineffective treatment and a faster path to remission. The same research group also found that early endoscopic changes during treatment can identify Crohn’s disease patients whose response is delayed, giving clinicians a window to intervene earlier in the treatment course.

Not all insights emerging from this research are purely biological. Shenghong Zhang and colleagues at Sun Yat-sen University found that early improvement in mental health symptoms predicts long-term disease remission in UC. IBD is typically monitored through endoscopy and blood tests. The finding suggests that psychological state during treatment may carry more clinical information than is currently recognized, and that a more complete picture of disease control may require looking beyond biology alone.

Behind each of these studies are patients who enrolled in research in the hope that their experience would help others. That contribution does not end at publication. IBD affects millions of people worldwide, and for many, the path to effective treatment involves years of diagnostic delay, failed therapies, and significant impact on quality of life. The work being done with Vivli-accessed data is producing findings that are reshaping how the field understands treatment response, disease monitoring, and the design of future research. Each new analysis builds on the last. This cumulative progress exists because study sponsors are meeting their obligations to participants, ensuring research data is used responsibly beyond the original study.

Learn more about accessing data through Vivli at vivli.org

Recent gastroenterology and IBD public disclosures associated with Vivli-hosted data include:

Placebo rates in randomized clinical trials of ulcerative colitis: an individual patient data meta-analysis— Journal of Crohn’s and Colitis | PI: Vipul Jairath, Alimentiv Inc. | Data Request 7288

Impact of concomitant corticosteroid use on adverse events in ulcerative colitis clinical trials — Journal of Crohn’s and Colitis | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 10381. Read the full case study on Vivli’s website.

Early Improvement of Mental Health Is Associated With Long-Term Disease Remission in Ulcerative Colitis— American Journal of Gastroenterology | PI: Shenghong Zhang, Sun Yat-sen University | Data Request 11327

Patients with ulcerative colitis that have endoscopic Mayo score 1 and active histologic inflammation have similar outcomes to mild-moderate patients: a post hoc analysis of the VARSITY trial— European Journal of Gastroenterology & Hepatology | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 11369

Serum and Histologic Eosinophilia as a Predictive Biomarker of Response to Mirikizumab in Ulcerative Colitis— Inflammatory Bowel Diseases | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 11425

Estimation of the Harvey Bradshaw Index from the Patient-Reported Outcome 2 in Crohn’s Disease— Inflammatory Bowel Diseases | PI: Reena Khanna, Lawson Health Research Institute | Data Request 7404

Comparative Predictive Utility of MM-SES-CD and SES-CD for Week 52 Endoscopic Remission in Crohn’s Disease— Inflammatory Bowel Diseases | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 10706

Week 12 Reduction in MM-SES-CD is Predictive of Delayed Response to Upadacitinib in Crohn’s Disease— Clinical Gastroenterology and Hepatology | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 11350

Impact of Age on Efficacy and Safety of Advanced Therapies During Induction in Ulcerative Colitis— Digestive Diseases and Sciences | PI: Vipul Jairath, University of Western Ontario | Data Request 7850

One-year Dynamics of Clinical Activity During Biologics Therapy in Ulcerative Colitis— Journal of Crohn’s and Colitis | PI: Shenghong Zhang, Sun Yat-sen University | Data Request 10032

Vivli Strengthens European Expansion, Appoints Jennifer O’Callaghan Executive Director of Vivli Europe

April 16, 2026

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.”

For more on the launch of Vivli Europe, see our earlier announcement: Vivli Expands Trusted Clinical Data Access with Vivli Europe (March 19, 2026).

Vivli Researcher Spotlight: Dr. Christian Lood on What a Routine Blood Test Can Reveal About Cancer Survival

April 7, 2026

For 4,484 patients enrolled across five Phase III oncology trials, the answer to an urgent question may have been present in their blood from the start. A study conducted using individual patient data accessed through Vivli, found that the neutrophil-to-lymphocyte ratio (NLR), derived from a standard complete blood count, independently predicted overall survival and progression-free survival across lung, colorectal, and gastric cancers. The findings were published in Frontiers in Oncology in July 2025.

Dr. Christian Lood, an Associate Professor at the University of Washington specializing in neutrophil biology and biomarker development, has spent his career building the case that neutrophils play a far more consequential role in cancer than the field has historically recognized.

“There is an emerging sense that neutrophils are instrumental in tumor development, he said. I wanted to highlight their unique role in cancer, to further development of novel biomarkers as well as therapeutic targets that are currently not considered in the field.”

Prior studies had proposed NLR as a prognostic marker, but inconsistent findings and limited large-scale validation had kept it from routine clinical use. The scale of data available through Vivli changed what was possible. By accessing records from five Eli Lilly-sponsored Phase III trials spanning three cancer types, Dr. Lood’s team conducted an analysis that earlier work could not support.

“Access to data through Vivli allowed us to analyze a larger patient population and wider variety of treatments than would have been feasible in a standard clinical setting,” he noted.

Baseline NLR proved to be an independent predictor of survival outcomes after adjusting for age, sex, and disease stage. Predictive performance was strongest in patients under 60, non-White patients, those with Stage IV disease, and those with lower functional status at baseline, a pattern that argues against uniform thresholds across populations. Longitudinal NLR change added little beyond the baseline reading. The initial measurement carries the primary prognostic signal.

Dr. Lood hopes the findings move NLR closer to routine use in oncology and open a research direction focused on soluble markers of neutrophil activation, which may prove more sensitive than cell counts alone in identifying patients with poor prognosis.

“I hope our research will trigger more studies into the potential clinical utility of neutrophil activation biomarkers in cancer patients,” he said.

The individual patient data from the five trials used in this analysis remain available through Vivli.

Further Reading

Performance of the neutrophil-to-lymphocyte ratio as a prognostic tool for survival in solid cancers — Frontiers in Oncology (July 2025)

News & Events

Category: Blog