News & Events

Tag: data reuse

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.

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 webinar: Vivli and RDCA-DAP: Data Platform Partnerships to Promote Rare Disease Data Sharing

Julie Wood, Vivli Chief Operating Officer, will join colleagues from Vivli and C-Path for a webinar on Thursday, February 20 at 12:00 pm ET. Julie will present an overview of Vivli’s global data-sharing and analytics platform and how Vivli’s collaboration with RDCA-DAP is advancing data sharing in rare diseases.

In addition to Julie’s presentation, the webinar will also include a panel discussion on platform-to-platform collaborations, strategies for facilitating data sharing, an interactive Q&A session with participants, and more!

View the Recording

 



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.

Rebecca Li, Vivli CEO, to join information session at #SCDM24

Vivli is pleased to announce that Rebecca Li will take part in an information session during the upcoming #SCDM24 Annual Conference. This event will take place in Boston September 29-October 2, 2024.

Li will participate in a session focusing on “nuts and bolts, best practices, and lessons learned on patient data sharing.” She will join colleagues Rebecca (Becky) Wilgus of the Duke Clinical Research Institute, Qiaoli (Lily) Chen of Pfizer, Jane Perlmutter of Gemini Group, and Marissa Stroo of the Duke University School of Medicine to share practical and applicable information that supports adoption of open data science, data sharing, and responsible data reuse from #clinical trials. 

SCDM24 will bring leading experts in clinical data management together with the wider community.
Get complete information and register to join in person. 

 



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.