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’s Incorporation of the Five Safes Framework

Vivli’s mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data. As a neutral broker between data contributor, data user, and the wider data sharing community, Vivli maintains the trust of our community and clinical research by placing the utmost value on the security and safety of the data available within the Vivli Platform, a secure research environment (SRE).

How does Vivli ensure that participant data provisioned within the SRE is used safely?

Vivli’s secure research environment aligns with the best practices established by the Five Safes framework. The UK Office of National Statistics initiated the framework, and other governments, institutions, and members of the data management community contributed to its refinement. Now internationally accepted as a standard, the framework ensures safe and secure access to data covering the lifecycle of data access within an SRE through five principles:

  • Safe People – all individuals who interact with the data are aware of their role in its protection
  • Safe Projects – projects are scientifically and ethically valid and deliver public benefit
  • Safe Data – potential for identifying participants is minimized
  • Safe Settings –organizational and technical controls to minimize the risk of disclosure
  • Safe Outputs – review of results and outputs to minimize the risk of disclosure

We provide examples of just a few ways we incorporate these principles into the Vivli Platform SRE.

Meet the 2025 Vivli Ambassadors

Vivli is proud to announce the selection of our 2025 Vivli Ambassadors. This diverse group of researchers has been chosen for their commitment to data transparency and their leadership in advancing clinical research around the world.

“We are delighted to have the interest and involvement by these researchers to advocate for data sharing and how sharing data can lead to novel insights and add to the scientific literature,” said Rebecca Li, Vivli CEO. “We look forward to supporting these researchers as they discuss their scientific findings.”

The Vivli Ambassador program aims to amplify the impact of data sharing by supporting researchers who are using the Vivli platform in innovative and meaningful ways. This group of dedicated researchers will talk about their research at conferences and through other means of dissemination. They will participate in user interviews, provide feedback to help improve the Vivli user experience, and contribute to conversations around responsible data reuse.

We congratulate the following researchers on their selection:

  • Dr. Diego Chowell, Icahn School of Medicine at Mount Sinai
  • Dr. Ashley Hopkins, Flinders University
  • Dr. David McAllister, University of Glasgow
  • Dr. Jonas Saal, University Hospital Bonn
  • Dr. Marco Valgimigli, Cardiocentro Ticino
  • Dr. Youssef Zeidan, Baptist Health South Florida

These Ambassadors represent a range of disciplines and geographic regions, and we look forward to sharing more about their work and experiences in the coming months.

Stay tuned as we highlight their stories and insights through our upcoming events and publications.

Celebrate Clinical Trials Day by sharing your data and get CRedIT!

Clinical Trials Day is celebrated on May 20, commemorating the day in 1747 on which James Lind is believed to have begun the first known controlled trial. Clinical trials remain the cornerstone of effective scientific and health research, and the clinical research data gathered provides valuable resources for further research, advancing science, and improving human health.

Sharing data is valuable not only to the research community, but also benefits the researchers who have conducted the trials and gathered the data. The Vivli platform enables researcher teams who submit and store their clinical research data to receive CRedIT on their ORCID profiles. Subsequent secondary analysis publications that are derived from the initial data are cited and tracked in Vivli.

Learn more about how data sharing with Vivli can contribute to your CRedIT in this new informational video.

Vivli launches Ambassador Program

Vivli is delighted to share that we have launched the Ambassador Program and selected our inaugural cohort of Ambassadors. The program was created to raise awareness of the importance of data sharing and reuse, as well as to promote the research opportunities available through the Vivli data repository.

Selected Ambassadors were eligible for financial support to attend conferences aligned with their research focus. A total of five travel grants of $2,500 were awarded. In addition to presenting their work, Ambassadors will participate in user interviews and testing twice a year to help guide the continued development of the Vivli platform.

Researchers who had successfully completed a project using data from the Vivli repository were invited to apply. Eligible researchers received a direct email invitation to submit a brief proposal outlining how they would promote research using the Vivli platform.

Read the full announcement here.

New Chair announced for Vivli Independent Review Panel

Vivli is pleased to announce the appointment of the new Chair to the Independent Review Panel (IRP). Dr. Sonali Kochhar, MD, will take on this role from 14th February 2025. Dr. Kochhar has already served as a member of the IRP for several years, bringing her wealth of expertise in Global Healthcare and clinical development.

Vivli CEO, Rebecca Li, PhD, welcomed Sonali as Chair, saying “We’re delighted to have Sonali take over as Chair of the IRP. Her experience and commitment will be invaluable going forward. ”

Vivli would also like to thank the longstanding IRP Chair, Jeff Koplan, who has served as Chair of the review panel since 2015.

“Jeff’s hard work and dedication in chairing the IRP for the last 10 years has been invaluable, and we wish him a happy retirement!” said Li.

Vivli Member Spotlight: Duke University Medical School

Duke University is a global leader in developing and sharing innovative clinical research that improves patient care and outcomes. Duke University School of Medicine has been partnering with Vivli since 2018 to foster the principles of open science and data access from clinical studies. In a newly published case study, researchers discuss the value of Vivli’s generalist data repository to share, manage, and re-use valuable clinical data: 

Interested in finding out more about how you or your institution can use Vivli’s generalist repository to share, manage, and re-use data more efficiently? Get answers to your questions on our FAQ page or contact Vivli User Support directly at support@vivli.org.

Vivli Researcher Spotlight: Assessing Clinical Trial Data on Cardiac Risk in Type 2 Diabetes Treatment

Dr. João Sérgio Neves is an endocrinologist, based in the Faculty of Medicine of the University of Porto and São João Hospital in Porto, Portugal. Dr. Neves’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Albiglutide and Cardiovascular Outcomes in Type 2 Diabetes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use”. The team’s completed research has been presented in publications including the Journal of the American College of Cardiology. Dr. Neves sat down with Vivli to tell us more about accessing individual participant data to advance his research, and the potential for combination therapy to reduce the risk of cardiovascular events in patients with Type 2 Diabetes.

Could you tell us a little bit about your research? What got you interested in the particular area of research that you carried out working with Vivli?

So I am a clinical endocrinologist; I do clinical research in the field of Endocrinology. I have a particular interest in the effects of endocrine diseases on cardiovascular risk and on cardiac function. My main areas of research have been obesity, diabetes, and pre-diabetes. Previous studies conducted by our team have explored the effects of GLP-1 receptor agonists in patients with diabetes, both with and without heart failure. One of the questions that was still unanswered from the literature was whether the benefits of GLP-1 receptor agonists were still observed in those that were already treated with SGLT2 inhibitors. These two classes of drugs are known to be protective from a cardiovascular perspective for patients with Type 2 Diabetes. However, the two classes were developed and the clinical trials were conducted in parallel. So when clinical trials of GLP-1 receptor agonists (AMPLITUDE-O trial and Harmony Outcomes study) were conducted a bit later and included participants that were already treated with SGLT2 inhibitors at baseline. The authors of the AMPLITUDE-O trial had already performed a sub-analysis evaluating the effects of the GLP-1 receptor agonists in patients treated with SGLT2 inhibitors. Given the relevance of further exploring the combination of GLP-1 receptor agonists with SGLT2 inhibitors, our group requested the Harmony Outcomes study from Vivli. The we also performed a meta-analysis combining the results of the Harmony Outcomes study with the results from the AMPLITUDE-O trial. So there are two trials that we included that evaluate the effects of GLP-1 receptor agonists and included some patients using SGLT2 inhibitors and we wanted to know if this data could help us understand if both drugs when combined can give further cardiovascular protection to patients with Type 2 Diabetes.

And having come to the conclusions that you did – that there may be further reduction in cardiovascular risk but that more clinical trials with combination therapy are required – have the findings from this made any impact in terms of research practice that you’re aware of, since the findings have become available?

So since the findings became available, there has been some interest from other doctors contacting us on how to interpret our findings. We are very cautious and we believe that further data and dedicated clinical trials are necessary to thoroughly evaluate this drug combination. However, acknowledging that these trials might take several years to be conducted, we also recognize that our existing data could assist physicians in making informed decisions about utilizing this combination in the interim. We believe that  the results of the Harmony Outcomes trial, in combination with the AMPLITUDE-O trial, favor the possibility that the combination of both drugs is protective from a cardiovascular perspective.

Interestingly, in the same month our paper was published in the Journal of the American College of Cardiology, the European Society of Cardiology published an updated guideline on the treatment of patients with Type 2 Diabetes and cardiovascular disease, and they recommended that patients with Type 2 Diabetes and cardiovascular disease should be treated with both drugs. They did not yet cite our paper because it was published just before publication of the guideline, but they do cite, for example, the AMPLITUDE-O trial. So I believe that our data will reinforce this recommendation; and we see that the field of treatment and prevention of cardiovascular disease in Type 2 Diabetes was already moving in the direction of our findings. But as there was only one study evaluating this combination, we think that our results will be very important for supporting the use of GLP-1 receptor agonists in combination with SGLT2 inhibitors.

Can you talk a little bit about using the data that was available through Vivli; what were you able to do using that data that you were not able to do otherwise?

The type of analysis we aimed to conduct could theoretically be performed using observational data. However, utilizing observational data poses significant challenges due to numerous confounders, particularly when assessing the effects of therapeutic interventions involving drugs. This limitation is well-documented, and such an approach would lack robustness, potentially raising more questions than providing answers. I think that the most interesting thing about the analysis that we performed was that this was a clinical trial that was already performed; the data was already available.

When we analyzed the data we worked with the authors from the primary paper; we got in contact with the authors of the primary analysis and we planned this analysis together. Our interactions with the original authors were invaluable in interpreting the data, given their familiarity with it. This collaborative effort resulted in an interesting analysis and yielded important results.

Can you talk a little bit about your experience of working with the Vivli platform – the processes and technology and what that was like?

I think that the process was quite easy, the instructions are clear. We know that there is always some type of bureaucracy that is involved, but that’s part of how it works, because we are dealing with data from patients. Of course it is anonymized data but I think that’s not different from what I was used to with other types of shared data. , The process works quite smoothly.

The thing that I feel that was a little bit different from our previous experience with secondary analyses, was the use of a platform for analyzing the data outside of our computers. Nevertheless, we successfully conducted our data analysis, and the data was also accessible within the remote computer, allowing us to execute the entire analysis seamlessly.

And how did you find out about Vivli and the opportunity to reuse shared data in general?

We had previously conducted analyses through the secondary analysis of existing data, utilizing platforms such as BioLINCC , which incorporates data from studies sponsored by NIH. Our awareness of Vivli stemmed from mentions in papers that disclosed their data sharing approaches, indicating that access could be facilitated through Vivli. This was my first personal experience using Vivli, and I must say that I find the work undertaken by the Vivli team truly remarkable. Your efforts contribute significantly to the future of research and the enhanced utilization of already collected data.

How has the direction of your own research been affected by the research that you did on this project? Has it affected what you’re doing or changed your direction in any way?

I believe it has provided clarity on the next steps to enhance knowledge in this field. In our team, we recognized that addressing whether the treatments were additive or not would be a pivotal question. If we discovered that the combination did not yield additional risk reduction, we needed to understand which drug to select for specific patients. With the results we obtained, our focus shifted towards understanding how to improve access to these drugs and assessing their effectiveness in other populations, particularly in the earlier phases of Type 2 Diabetes and even pre-diabetes. As we design new clinical trials, we are already incorporating the insights gained from this analysis.

Would you use the Vivli platform again? Are there any changes or improvements that you would recommend to how it works?

Certainly, the experience was highly positive, and I look forward to working again with Vivli in the future. One overarching improvement (that’s not specific to Vivli) would be to expand access to even more data. I do believe that the data is very valuable and that it is very important to share the data from large clinical trials. The type of study that we analyzed is probably the most relevant that should be shared – of course with a very specific and detailed analysis plan and with all the regulations that are needed in this context. Considering the substantial resources and time invested in these clinical trials, there is often a wealth of data that remains untapped. Many crucial analyses may not have been conducted and researchers not primarily involved in the clinical trial may be able to identify these questions and answer them using the data from that trial. Therefore, it is important to facilitate access to this valuable resource.

So my main recommendation is to try to increase even further the number of studies that are available. Of course this also depends on the companies that own the data and the drugs that are being evaluated. But our analysis could not be performed without the sharing by GSK, so we are also thankful for their contribution to Vivli and for the sharing of the data.

And is there any advice you would give to other researchers who are at the beginning of the process of requesting or using shared data?

My main advice is to have a very specific question that the researchers want to answer; develop a detailed analysis plan; and submit the request to the Vivli platform. While the process may take some time, it is not overly complex. With patience and adherence to the required steps, one can successfully obtain access to the data. I firmly believe that enhancing the utilization of the Vivli platform and increasing access to data from large clinical trials will significantly improve the quality of knowledge across various fields in medicine.