News & Events

Tag: clinical trial 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.

Vivli Webinar: Unlock the Power of Data Analysis in Vivli: Practical approaches to understanding the data and delving deeper into the CDISC standard

Are you a researcher who has analyzed data on Vivli? Or has your research team already analyzed data in the Vivli platform but is looking for more efficient approaches?

This 3-hour training will provide researchers with a practical approach to understanding the data, provide an overview of CDISC, and how this data standard can help you understand the data. It is aimed at clinical researchers and biostatisticians interested in analyzing data in the Vivli platform. There will be an opportunity for participants to ask questions.

View the Recording

Topics include:

  • Understand the type of datasets and supporting documents received after approval.
  • Understand CDISC, SDTM and ADaM? How can these standards help make my analysis more efficient?
  • How to conduct reproducible, safe, open and efficient analyses with special considerations for secondary trial analyses within the Vivli environment.

Speakers & Panelists:

  • Jack Shostak, Director of Biostatistical Operations, Duke & CDISC instructor
  • David A McAllister, Professor of Clinical Epidemiology and Medical Informatics and Honorary Consultant in Public Health Medicine, University of Glasgow
  • Nicole Harmon, COO, CDISC
  • Rebecca Li, CEO, Vivli

View the Recording

 

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 Webinar: The Power of Sharing Clinical Trial Data: How to Build a Data Sharing Program While Protecting Participant Privacy


Vivli partnered with Real Life Sciences (RLS) to present this webinar on Thursday, February 20 at 10:00 am ET. Presenters explored how RLS and Vivli enable secure data sharing for study sponsors. Participants learned key steps to launching a data-sharing program and discovered why empirical data anonymization techniques are essential for maintaining participant privacy while maximizing research value.



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.