News & Events

Vivli Researcher Spotlight: Examining survivor function data across multiple trials for kinetics of stroke recurrence

James Brorson is a professor of neurology at the University of Chicago, with a research focus on vascular neurology. He has more than 25 years of patient care experience, as well as laboratory and clinical research. He has served as a principal investigator for several clinical trials in secondary stroke prevention, and currently serves as medical director of the University of Chicago Comprehensive Stroke Center, which cares for more than 400 stroke patients annually.  

Dr. Brorson’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Examination of survivor functions from SOCRATES and THALES trials for kinetics of stroke recurrence.” The team’s completed research has recently been presented to the research community in publications including Neurology and Stroke

Stroke is a common and often devastating condition in which blockage of blood flow to a part of the brain leads to its destruction, with corresponding loss of function, producing a variety of symptoms. Stroke is a leading cause of death and long-term disability globally. In the United States, some 800,000 persons suffer strokes each year, and more than 100,000 die.

A person who suffers a first stroke classified as mild is at increased risk of a second, often more severe stroke. The risk of recurrence is highest in the immediate aftermath of the first stroke, and prevention efforts frequently concentrate in the 12-24 hour period following the first incident. The rate of recurrence declines over time, and researchers have theorized that examination of the time course for the timing and rates of stroke recurrence may provide insight which may help with devising better ways to prevent recurrent strokes. 

Dr. James Brorson and a team of colleagues set out to harmonize, merge, and assess data gathered from participants in three large trials in the aftermath of a first stroke event. Their aim was to determine whether treatment decisions could be made more precisely based upon analysis of timing and rates of stroke recurrence. They accessed data from more than 25,000 participants in order to provide sufficient statistical power to detect modifiers of early and late kinetics of stroke recurrence.

To carry out their analysis, the team developed a two-state kinetic model of stroke recurrence. This model proposes an initial vulnerable state with a higher rate of stroke recurrence, which rapidly transitions to a stabilized state with a lower rate of recurrence. They further theorized that this model would fit the survival data for each of these recent trials of acute secondary prevention better than would a model assuming only a single clinical state after the initial minor stroke.

The team’s findings established that recurrence of stroke is well-described by a two-state kinetic model postulating vulnerable and stabilized states, with similar kinetic parameters across the three trials. Their analysis also indicates that enhanced antiplatelet regimens only affected the recurrence rates during a brief period in the vulnerable state. This suggests that two distinct states follow acute cerebral ischemic events, and that these states are subject to differential impact of immediate or delayed therapies. 

These findings have been published in the academic journals Neurology and Stroke. The authors are also working on a second phase of this project to harmonize and curate the data from the first phase into a single large dataset. When complete, they plan to re-share this dataset on the Vivli data repository to support further research in this area, providing additional opportunities for analysis and identification of new methods to prevent stroke recurrence.

 

Read more about Dr. Brorson’s research:

Examination of survivor functions from SOCRATES and THALES trials for kinetics of stroke recurrence (Vivli Research Request 6550)

Vulnerable and Stabilized States After Cerebral Ischemic Events: Implications of Kinetic Modeling in the SOCRATES, POINT, and THALES Trials (Neurology

Abstract WMP61: Vulnerable And Stabilized States After Cerebral Ischemic Events: Implications Of Kinetic Modeling In The POINT, SOCRATES, And THALES Trials (Stroke)

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

 

Vivli Researcher Spotlight: Investigating the early stroke recurrence rate for people who have experienced minor strokes

Ischemic strokes are caused by temporary disruption of blood flow to the brain, and include transient ischemic attacks (TIAs), commonly known as mini-strokes, as well as minor and major strokes. TIAs and minor strokes do not usually have significant long-term effects in and of themselves, but they are important as warning signs of the potential risk of a more significant stroke.

In carrying out research, TIAs are often considered alongside minor strokes, or as a distinct category. However, there has not been significant research to date focusing on minor stroke as a distinct category, particularly with regard to the potential for recurrence in the short term. Developing a better understanding of minor stroke could help improve patient care as well as advance medical knowledge. In a recently completed study, Dr. Andy Lim and colleagues focused on answering the question of whether isolating data relevant to minor stroke could provide useful information about the potential for recurrence. 

This meta-analysis involved assessing individual patient data from 45,462 participants in 14 included research studies. The findings indicate that the pooled 90‐day stroke recurrence rate for minor stroke as a distinct category is 8.6%. Furthermore, this rate appears to be declining by 0.60% per year—a trend which seems consistent with those associated with improving outcomes associated with contemporary management of minor stroke and TIA assessed together, as well as for TIA outcomes assessed alone. 

Establishing a better understanding of the baseline recurrence rate of minor ischemic stroke can help with comparing new treatments, developing new clinical pathways, and identifying improved methods for managing care. Using the Vivli platform gave the research team access to data from Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack (SOCRATES) trial data, which Dr. Lim described as “an important piece of our meta-analysis puzzle. Without it, we would not be able to complete the picture.”

Read more about Dr. Lim’s research:

Meta-analysis of early stroke recurrence rate in minor stroke (Vivli Research Request 6866)

Ninety‐Day Stroke Recurrence in Minor Stroke: Systematic Review and Meta‐Analysis of Trials and Observational Studies (Journal of the American Heart Association)

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

Vivli Researcher Spotlight: Examining serological status to better understand treatment response in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disorder, which primarily affects the joints and is characterized by inflammation and pain. RA most commonly affects the hands and wrists, but can also affect other parts of the body. There is currently no cure for RA, but treatment options have improved considerably in recent years with the development of new therapies and treatment strategies.

Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are well established as a standard treatment for RA, used to slow down progression of the disease through broad restriction of the immune systems. Biologic DMARDs (bDMARDs) take a more targeted approach, but it is unclear if it is equally effective across the spectrum of types of RA. In particular, the serological status of people diagnosed with RA may be linked to long-term outcomes. Also,  based on differences in associations with genetic and environmental risk factors, seropositive and seronegative disease are presumed to have different underlying pathophysiological mechanisms. However, whether serological status may also affect treatment responses to biological disease-modifying anti-rheumatic drugs (bDMARDs) is not completely clear. 

In a recently completed study, Dr. Kaoru Takase-Minegishi and colleagues undertook a meta-analysis based on a systematic literature review including data from 28 randomized controlled trials (RCTs). The research team’s goal was to investigate whether the efficacy of bDMARDs differs in seropositive RA patients (seropositive) compared to those classified as seronegative. Some of the study participants were also receiving csDMARDs, while other were treated bDMARDs exclusively.

The research findings indicate that seropositivity was not associated with a better response to bDMARDs, regardless of whether patients were also receiving csDMARDs. Other outcomes mostly showed no significant difference between the groups, and efficacy was generally comparable between seropositive and seronegative patients for a range of treatment protocols. 

Using the Vivli platform enabled the research team to include previously unpublished data, the first opportunity to perform meta-analysis on this complete dataset. Previously unpublished data are included in the Supplementary Material, available online alongside the article recently published in the journal Rheumatology. This research provides a very important additional perspective to the data reported from observational studies thus far, uncovering essential differences. 

Read more about Dr. Takase-Minegishi’s research:

Effect of rheumatoid factor and anticitrullinated peptide antibody on the efficacy of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis (Vivli Research Requests 4922, 3274)
The Impact of Autoantibodies (RF and ACPA) on the Efficacy of Biological Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis: Meta-analysis of Randomized Controlled Trials (Abstract, American College of Rheumatology Convergence 2022)
The impact of autoantibodies (RF and ACPA) on the efficacy of biological disease-modifying antirheumatic drugs in rheumatoid arthritis: meta-analysis of randomized controlled trials (Annals of the Rheumatic Diseases)
The impact of autoantibodies on the efficacy of biological disease-modifying anti-rheumatic drugs in rheumatoid arthritis: meta-analysis of randomized controlled trials (Rheumatology)

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

Vivli Researcher Spotlight: Rethinking Rheumatoid Arthritis Management: The Dual Target Strategy

Rheumatoid arthritis (RA) poses a significant challenge due to its chronic nature and impact on joint health. While treatments have evolved, achieving remission remains elusive for many patients. Using a dataset from the Vivli repository, Dr. Ricardo Ferreira and a team of researchers delved into examining the assessment criteria for remission in RA, shedding light on the limitations of current approaches and proposing a new model—the dual target strategy.

The current standard of treatment is the Treat-to-Target (T2T) approach, which aims for remission or low disease activity. Dr. Ferreira’s team questioned the reliance on a single criterion, the patient global assessment (PGA/PtGA), included in composite measures for determining remission. Their study, drawing from extensive clinical trial data, notably revealed that 19% of patients failed to attain remission based solely on this patient-reported assessment, leading the team to explore a more comprehensive model. In a recent conversation with Vivli, Dr. Ferreira highlighted the research’s key finding: the lack of significant difference in radiographic outcomes between patients classified as “PGA-near-remission” versus those in full remission. This challenges the established understanding of remission incorporating the patient global assessment.

The research team has proposed a dual target strategy, which integrates patient-reported outcomes with objective measures like inflammation status and joint counts to assess inflammatory status and guide immunosuppressive therapy management. The second target (disease impact) would be assessed by informative patient-reported outcome measures, other than PGA. By assigning equal significance to subjective experiences and clinical data, this innovative approach proposes a new benchmark for remission in RA management. Moreover, it has the potential to guide both pharmaceutical and nonpharmacological interventions.

It is anticipated that the dual target strategy has a more patient-centric approach; integrating subjective experiences with objective clinical markers holds promise for improving treatment efficacy and enhancing patient outcomes. With key RA researchers expressing interest in this model, the dual target strategy could significantly change both RA management, and the experience of patients navigating this complex condition. A pragmatic, multicenter, randomized controlled trial is currently being prepared to test this strategy.

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

 

Vivli Researcher Spotlight: Reusing Data from a Completed Clinical Trial to Inform Guidelines

In a recent study led by Dr. Sarah Nevitt, a senior research associate at the University of Liverpool, a team of researchers examined the effectiveness of various antiepileptic drugs (AEDs) used as monotherapy for people experiencing seizures due to epilepsy. Epilepsy, a common neurological disorder, results from abnormal electrical discharges in the brain, causing recurrent seizures. Typically, around 60% to 70% of individuals with epilepsy achieve longer-term remission, often shortly after beginning treatment with antiepileptic drugs.

Dr. Nevitt and her team sought to compare the performance of 12 different AEDs in terms of treatment failure, remission, and occurrence of first seizures among both children and adults with focal onset or generalized tonic‐clonic seizures. They analyzed data from an extensive collection of clinical trials encompassing more than 22,000 participants, incorporating individual patient data from various studies using a network meta-analysis.

The analysis revealed some key insights. Older drugs like phenobarbitone and phenytoin demonstrated better seizure control for both focal and generalized seizures but had poorer long-term retention rates compared to newer medications such as lamotrigine and levetiracetam. Sodium valproate emerged as the top choice for achieving control and remission of generalized tonic‐clonic seizures, although it might not be suitable for everyone, especially people of childbearing age, due to associated risks.

These findings, published in the Cochrane Library, have already influenced the update of UK guidelines in 2022, providing immediate impact on the treatment of individuals newly diagnosed with epilepsy in the UK. In a recent conversation with Vivli, Dr. Nevitt highlighted that these results are guiding the approach to epilepsy treatment, emphasizing the importance of considering both efficacy and potential side effects when selecting appropriate medications for individuals experiencing seizures.

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.



AMR Data Challenge Grand Prize Winners are leveraging the power of AI to combat antimicrobial resistance more effectively

The World Health Organization (WHO) has identified Antimicrobial Resistance (AMR) as one of the top 10 global health threats facing humanity. Projections warn that antimicrobial-resistant infections have the potential to become the leading cause of death by 2050.

Recognizing the need for action on this pressing public health issue, Vivli joined forces with Wellcome in 2022 to launch the AMR Register. This innovative resource houses a growing collection of datasets shared by industry partners, offering consolidated access to surveillance data collected on dozens of antimicrobial interventions.

To raise awareness and encourage reutilization of this wealth of data, Wellcome funded the launch of the AMR Data Challenge in April 2023. The event offered a unique opportunity for multidisciplinary teams to access and leverage high-quality AMR surveillance data, and 56 teams from 28 countries submitted project proposals. The participating teams submitted a wide range of innovative proposals, making use of datasets contributed by GSK, Johnson & Johnson, Paratek, Pfizer, Shinogi, and Venatorx. 

Submitted proposals were assessed by a judging panel of international experts, who selected six outstanding proposals for recognition as winners of the AMR Surveillance Open Data Reuse Data Challenge. ​​The team that received the Grand Prize was led by Dr. Fredrick Mutisya, Health Data Scientist & Medical Doctor of Narok County, Kenya, and Dr. Rachael Kanguha, Pediatrician, Chuka County Referral Hospital, Kenya. 

Their groundbreaking work involved training machine learning models on the Pfizer ATLAS datasets and the development of a novel artificial intelligence web application capable of predicting antibacterial/antifungal susceptibility. Their proposal notes that traditional methods of prediction have proved insufficiently dynamic to cope with the growing amount of genomic data available, or to effectively monitor and predict trends in antimicrobial resistance, leaving gaps in researchers’ understanding and ability to respond. Their goal is to showcase the best predictive model in order to enable proactive measures and early detection of emerging resistance patterns, and provide a model for ethically and effectively integrating AI into an evidence-based epidemiology approach.

Dr. Mutisya expressed his team’s commitment to AMR and highlighted the importance of providing equitable data accessibility to scientists from his region:

“Our team feels incredibly privileged to have participated in such a meaningful data challenge. Winning the grand prize not only fills us with a profound sense of fulfillment but also ignites a stronger motivation within us to continue seeking solutions for global issues, especially in combating antimicrobial resistance,” he said. “We are deeply grateful to Vivli for providing a platform that facilitates data accessibility. This is particularly significant for scientists like us hailing from the Global South, where opportunities like these are often scarce.”

Five other teams, including scientists from Australia, China, France, India, Spain, the United Kingdom, and the United States, were recognized by the judging panel for proposals which demonstrated notable impact and innovation. A complete list of the winning proposals and finalists is available on the Vivli AMR platform

Members of the judging panel commented favorably on the excellent quality of the proposals submitted, the innovative approaches used, and creative solutions developed. One of the judges, Professor Marc Mendelson, also noted the importance of open access to data, calling it “a fundamental key to driving innovation towards a better understanding of AMR and the mitigation of this global health crisis.”

The Challenge is over for 2023, but the work of fighting AMR goes on. If you are interested in accelerating research and tackling a global public health challenge at the same time, explore Vivli’s AMR surveillance data sharing platform and find out how you can request access to data.

There’s more on Vivli than just clinical trial data

Did you know there’s more on Vivli than just clinical trial data? The majority of our repository of data comes from clinical trial data, but also includes significant numbers of platform trials, observational studies, and real-world evidence resources.

Vivli’s repository of data from nearly 7,000 research studies is available to search freely. Enter any relevant keyword and you’ll get a listing of pertinent studies of different kinds. Here are some recent search results using common keywords for studies that are not clinical trials: 

Observational: 198

Natural history: 26

Platform trial: 420

Explore our How To Guides to learn more about accessing and searching for data with Vivli. If you’d like to take your research further, you can get in touch with us for more information about specific studies or requesting access to data.

Vivli to host workshop at 2023 Cochrane Colloquium

Vivli will host a workshop at the 2023 Cochrane Colloquium in London on September 4. The Cochrane Colloquium is an annual event for Cochrane in support of its mission to promote evidence-informed health decision-making. 

Vivli’s workshop will focus on “Practical advice for accessing patient-level data from a data sharing platform for evidence synthesis.” This session will provide: 

  • an introduction to the Vivli platform, including an overview of data available and hands-on group work on how to submit a request for data
  • an overview of first-hand experience of using patient level data using Vivli’s data sharing platform as a case study 
  • a discussion session focusing on some of the opportunities and challenges associated with using patient level data (for example: what to do when data needed to answer the hypothesis is not available via a single data sharing platform?)

This session will be a mixture of hands-on practice and opportunities to hear from researchers who have used the platform, patient advocates, and data providers. There will also be time for participants to ask questions about the data access process. 

Vivli Senior Director Julie Wood will be joined by Alan Chant, the patient representative on the Independent Review Panel; Catrin Tudur Smith from the University of Liverpool; and Rebecca Sudlow from Roche to facilitate this workshop. 

For more information on the 2023 Cochrane Colloquium and to register for this session, please see the event schedule. Please note that participation in this session is open only to registered Colloquium attendees. 



Public Disclosures

Vivli aims to advance human health through clinical research data sharing. One of the key ways we support this is through the Vivli platform, which facilitates data sharing for research teams working on a range of topics.

These tables provide details of approved research proposals that have published or presented their results.

How to Guides

Vivli provides the following resources to assist users of the Vivli Platform:

Data Request Guidance and Support

ResourceDescriptionLink
Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit a request for study data.Download PDF
Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
Vivli How To – Requesting StudiesHow to request studies through the Vivli platform.Download PDF
Vivli Data Request Quick Start (Video)A 3-minute video showing how to submit a data request.Watch video
Vivli Platform demo – How to search, request, and analyze data on VivliA short video showing how to request data on VivliWatch video
Vivli Lay Summary Training VideoHints and tips for completing your Vivli Lay Summary as part of your data request.Watch video

Download PDF
Vivli Data Request Form WorksheetWorksheet of information needed to complete a Vivli data requestDownload
Vivli Data Request Form Tips and TricksHints and tips for completing your Vivli Data Request Form.Download PDF
Data Request Form SampleExample of fully completed Data Request FormDownload PDF
Vivli Policies in BriefSynopsis of key policies governing interactions between researchers and data contributors during the lifecycle of a research proposal.Download PDF
Software and R Packages Available in the Research EnvironmentAnalytical and other software available in the research environmentDownload PDF
Vivli AI/ML Model RequirementsVivli's AI/ML policy outlines strict requirements for model data anonymization and limits export to traditional machine learning models.Download PDF

Study Submission Guidance and Support

ResourceDescription
Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit your study.Download PDF
Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
Vivli How To – Study submissionData sharing instructional videoWatch Video
Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload
ICMJE Data Sharing RequirementsHow to use Vivli to meet ICMJE data sharing requirementsDownload PDF

NIH DMSP Guidance

Fill out the form below to access all the DMSP Guidance provided by Vivli.

    What best describes your current role?

    Do you plan to include Vivli in any future data management plans?