News & Events

Category: Blog

Vivli Webinar: Navigating Clinical Trial Data Sharing Under the New Declaration of Helsinki: Practical Steps for Instituting an Ethical and Effective Program

Take part in this webinar, where will discuss the New Declaration of Helsinki and how institutions can take practical steps to institute an ethical and effective data sharing program.

Join us on Thursday, January 23 at 8am PST/11am EST/4pm GMT, for a discussion with Vivli’s CEO Rebecca Li and COO Julie Wood about the top five questions companies or non-profit foundations should ask when they are considering embarking on a data sharing program.

Register

Topics include:

  • Why should we share clinical trial data?
  • When should we begin a data sharing program?
  • How do we start to build a data sharing program?
  • How can we manage a data sharing program?
  • What can a partner like Vivli do for us?

Speakers:

  • Rebecca Li, CEO, Vivli
  • Julie Wood, COO, Vivli

Register

Event: 2024 Vivli Annual Meeting – Innovations in Data Sharing

This event was held at Harvard Faculty Club in Cambridge, MA, on Friday, November 15, for the 2024 Vivli Annual Meeting, co-hosted with the MRCT Center of Brigham and Women’s Hospital and Harvard. The meeting focuses on Innovations in Data Sharing and features a keynote address from Steffen Thirstrup, CMO of the EMA. He speaks on the European Health Data Space.

 

RECORDINGS SPEAKER BIOGRAPHIES

Session topics focus on the following areas:

  • Keynote address: Steffen Thirstrup, EMA on European Health Data Space
  • Panel discussion on European Health Data Space
  • Health Information Exchanges
  • Risks and Opportunities in AI and data sharing

Agenda

 

Keynote: Steffen Thirstrup, CMO, European Medicines Agency (EMA)

Looking to the future: The opportunities for data sharing and the European Health Data Space

RECORDING

Panel Discussion: The Opportunities for data sharing and the European Health Data Space (EHDS)

Following on from the keynote address, panelists discuss the potential of the EHDS.

Moderator: Rebecca Li, CEO and Co-founder, Vivli

  • David Leventhal, Data Sharing & Disclosure Lead, Pfizer
  • David McAllister, Professor of Clinical Epidemiology and Medical Informatics, University of Glasgow
  • Steffen Thirstrup, CMO, EMA
  • Aneta Tyszkiewicz, Director, Digital & Data, EFPIA

RECORDING

Panel Discussion: Use of Health Information Exchange (HIE) data for research: legal and ethical challenges

The panel discusses challenges related to the use of HIEs and other U.S. data sharing frameworks for research purposes, including research recruitment, retrospective studies, and more.

Moderator: Barbara Bierer, Faculty Director, MRCT and Vivli co-founder

  • Jill De Graff, VP of Regulatory, b.well Connected Health
  • Irene Koch, Executive Vice President and Chief Legal Officer, Hospital for Special Surgery, New York City
  • David Peloquin, Partner, Ropes & Gray

RECORDING

Panel Discussion: Risks and Opportunities in AI and data sharing

Panelists discuss AI’s risks and opportunities for sharing and re-using data today and in the coming years.

Moderator: Ida Sim, Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder

  • Karla Childers, Head, Bioethics-based Science & Technology Policy, Johson & Johnson
  • Dawei Lin, Associate Director for Bioinformatics & Senior Advisor to the Director at DAIT, NIAID, NIH
  • Subha Madhavan, Vice President & Head of AI/ML, Quantitative & Digital Sciences, Research and Development, Pfizer and Vivli Board member
  • David Peloquin, Partner, Ropes & Gray

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.

Vivli Researcher Spotlight: Using clinical trial data to assess the impact of empagliflozin on non-cardiovascular hospitalizations in patients with heart failure

Lower respiratory tract infections (LRTI) are a frequent complication for elderly patients with heart failure. Non-cardiovascular hospitalizations, including respiratory infections, cause around 50% of the hospitalizations in heart failure patients, making them comparable to cardiovascular hospitalizations in terms of health and resource use impact. However, little is known about the causes and associated prognosis of non-cardiovascular hospitalizations in patients with heart failure.

Empagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor, a class of medicines primarily used to lower blood sugar in adults with type 2 diabetes. In a recently completed study, Dr. João Pedro Ferreira and colleagues aimed to study the potential impact of empagliflozin on LRTI. The research team’s goal was to determine whether empagliflozin could reduce LRTI, due to its capacity to reduce oxidative stress and improve host defense mechanisms.

The research findings indicate that LRTI was frequent in the cohort of enrolled participants, and associated with a poor prognosis. The total number of LRTI events was reduced in the empagliflozin group, compared to placebo.

Using the Vivli platform enabled the research team to include previously unpublished data which were unavailable anywhere else. This research is another addition to the list of benefits of these SGLT2 inhibitor agents; Dr. Ferreira noted that, since heart failure exacerbations and respiratory infections often go “hand-in-hand”, showing that empagliflozin can reduce the incidence of these is good news for patients.

Next Steps

Read more
Non cardiovascular hospitalizations in heart failure and preserved ejection fraction (HFpEF) and the effect of empagliflozin (Vivli Data Request 8933)

Empagliflozin and risk of lower respiratory tract infection in heart failure with mildly reduced and preserved ejection fraction: An EMPEROR-Preserved analysis (European Journal of Heart Failure)

Find out more about requesting data from Vivli

Vivli version 3.4 of the platform has been released

Version 3.4 of the Vivli platform has been released and is available to users. The key change with the new version of the platform is users can now submit an enquiry directly on the platform about studies that are not listed in the Vivli search. This change is aimed at supporting researchers and Vivli members so that it is a more seamless process.

“Our members have asked to move the enquiries process to the platform and so we have made this change,” said Julie Wood, Vivli COO. “We think this will allow easier tracking of enquiries. It makes it easier for our members to interact with users and if that study is eligible to be shared, it makes it much easier for a researcher to include it in a data request.”

Other usability features have been added and Vivli how to guides have been updated.

Vivli CEO Rebecca Li to participate in panel discussion for Harnessing the Potential of Patient-Level data in Clinical Trials     

Vivli’s CEO, Rebecca Li, will speak on Day 3 at the Global Clinical Trials: Technology & Innovation webcase series. This online event will take place on May 14-16, 2024. Li will participate as a panelist in a discussion session on ‘Harnessing the Potential of Patient-Level data in Clinical Trials.’

Explore the practical benefits of patient-level datasets in clinical trial as industry experts discuss strategies for implementing fully consented patient data and its impact on trial outcomes. The panel will be held on Thursday, May 16th, 5pm CEST / 4pm BST / 11am EDT. Learn more and register here.

Vivli launches Case Studies to showcase the work of our innovative researchers

Vivli is delighted to announce the launch of our new Case Studies series, designed to highlight the work of researchers around the world who are using the Vivli data repository to produce innovative research and original approaches to diagnosis and treatment for a variety of conditions. Our first compilation of case studies focuses on analyses relevant to Type 2 Diabetes, Rheumatoid Arthritis, cancer, and more.

We’ve developed Case Studies to showcase the variety of valuable projects happening with the support of data-sharing initiatives across the research community. Vivli’s repository of data is built on more than 7,000 research studies across a wide range of research areas, and includes a growing number being shared by individual researchers. This data repository provides a valuable resource for researchers to both share and access data that can be used to accelerate the progress of scientific research.

Are you a researcher whose work uses or produces individual patient data? We’d love to hear from you, whether you’ve got data to share, are interested in exploring our data resources to submit a request for your next project, or would like to see your work included in the Case Studies series.

Contact Vivli

Find out more about how Vivli can support your research

Vivli Researcher Spotlight: Making an Impact in Oncology Treatment Using Individual Patient-Level Data

Analyzing individual patient-level data (IPD) from completed clinical trials to glean additional insights about patient populations is a key benefit of data sharing and reuse. Dr. Ashley Hopkins and his research colleagues have identified clinical trial data as an important source of information, particularly on emerging treatments which may not yet have a large pool of real world data. They have successfully leveraged data from the Vivli platform across multiple health areas, with a particular focus in oncology, including across lung, breast, and neural cancers.

In a recent conversation with Vivli, Dr. Hopkins talked about his research projects, including a recent example involving a significant finding related to potential associations between proton pump inhibitor use and outcomes with the monoclonal antibody atezolizumab. When used in combination with bevacizumab (another monoclonal antibody), and chemotherapy medications such as carboplatin and paclitaxel, the research team identified associations which could alter survival outcomes.

Dr. Hopkins and his colleagues have also used IPD available on the Vivli platform to inform a number of other questions, which have produced multiple publications over the last several years.

“I come from a perspective of being a pharmacist, which has led me on a journey and transition across the research,” said Dr. Hopkins. “I still want to be able to provide patients with the best possible information about the medicines.”

Read more about Dr. Hopkins’ research:

Efficacy of Atezolizumab in Patients With Advanced NSCLC Receiving Concomitant Antibiotic or Proton Pump Inhibitor Treatment: Pooled Analysis of Five Randomized Control Trials (Journal of Thoracic Oncology)

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: The Potential Impact of Recent U.S. Legal Developments on Data Sharing with China and Other Countries of Concern

Vivli held a webinar to discuss recent developments in data privacy laws and their impact on data sharing.

This webinar was held at 5pm CEST / 11am EDT / 8am PDT on Friday, April 12th

VIEW THE RECORDING

Over the past few weeks there have been significant U.S. executive and congressional actions related to restricting transactions, data transfers, and certain types of contracts with China, other countries of concern (e.g., Russia), and individuals and businesses connected with these countries. Principally, this includes President Biden’s Executive Order (“EO”) on bulk sensitive personal data transfers and the corresponding U.S. Department of Justice Advance Notice of Proposed Rulemaking (“ANPRM”), the unanimous passage by the U.S. House of Representatives of the Protecting Americans’ Data from Foreign Adversaries Act, and the passage of the BIOSECURE Act by a critical Senate Committee.

All three of these developments, if finalized, will have important impacts on the sharing of data and biospecimens with China and certain other jurisdictions that have been labeled “countries of concern.” In this presentation, Ropes & Gray partner, David Peloquin, will walk through these different proposed regulations and legislation, focusing on the implications they each may have for research data sharing. He will also discuss the different timelines and comment periods for the EO and ANPRM, as well as the current status of each of the pending pieces of legislation.

Speaker:

  • David Peloquin, Partner, Ropes & Gray

Learning objectives for this session include:

  • Understanding the basics of the EO, the ANPRM, the BIOSECURE Act and the Protecting Americans’ Data from Foreign Adversaries Act
  • Understanding how each of these proposed regulations or pieces of legislation may affect research data sharing with China and other countries of concern
  • Understanding the potential timelines for implementation of each of these proposed regulations and pieces of legislation

VIEW THE RECORDING

Awardees Announced for Helmsley’s T1D Exercise Data Challenge

In September 2022, the Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program announced the launch of an initiative to support novel, real-world solutions to help people with Type 1 Diabetes exercise safely and to improve their quality of life. To help address knowledge gaps about the effect of exercise on T1D, Helmsley collaborated with the Jaeb Center for Health Research (JCHR) and a group of investigators to conduct two large observational exercise studies in people with type 1 diabetes (T1D): one in adults (T1-DEXI) and https://doi.org/10.25934/PR00008429. More than 500 adults took part in the study, and another 250 children in the pediatric study.

“The Helmsley Charitable Trust showed great foresight in how they took a long-range view to ensure the observational studies were available in a standardized format to ensure that researchers can understand and analyze this important data,” said Rebecca Li, Vivli CEO. “We were delighted to partner with them to support this RFP process and look forward to this next round of research continuing to drive forward the science in Type 1 Diabetes.”

The research collaboration collected observational data relevant to types of physical activity, heart rate, insulin use, CGM, diet, and genetics. After organizing the data in CDISC standards to maximize interoperability, Helmsley partnered with Vivli to make the data from T1-DEXI and T1-DEXIP publicly available, and launched a data challenge designed to encourage researchers, clinicians, and data scientists to explore the data and test novel solutions in people with T1D.

Researchers who have approved requests for the RFP

The table provides the information of researchers who have accessed the Jaeb Center for Health Research T1D Exercise Dataset via Vivli and indicated that they will be applying for the Helmsley request for proposal.

ResearcherInstitution
Emily FoxStanford University
Dale MorrisonUniversity of Melbourne
Hector Romero UgaldeDiabeloop SA
Marzia CesconUniversity of Houston
Monia RekikUniversité Laval
Boomer OlsenUniversity of Utah
Janet Snell-BergeonUniversity of Colorado
Ali CinarIllinois Institute of Technology
Jenna WiensUniversity of Michigan
Arsalan ShahidCeADAR: Ireland's Centre for Applied AI at University College Dublin
Daniel WestNewcastle University
Ahmad HaidarMcGill University
Temiloluwa PrioleauDartmouth College
Michelle CondrenUniversity of Oklahoma
Joanna DaviesBallad Research Institute
Marie MoulerSchneider Children’s Medical Center of Israel
Marc BretonUniversity of Virginia
Garrett AshYale University
Lisa ChowUniversity of Minnesota
Erin TallonChildren's Mercy Kansas City
Norou DiawaraOld Dominion University
Giacomo CapponUniversity of Padova
Konrad MulrennanAtlantic Technological University
Fabricio GarelliNational University of La Plata
Micaela MorettiniUniversità Poiltecnica delle Marche
Xiaohua Douglas ZhangUniversity of Kentucky
Eleonora Maria AielloUniversity of Trento
Bryan GibsonUniversity of Utah
Roeland MiddelbeekJoslin Diabetes Center
Yao QinUCSB
Thomas HawkeMcMaster University

Following review of concept notes and full proposals, Helmsley announced on February 13 that more than $12 million in grant funding would be awarded to support seven new projects. These will focus on a variety of initiatives relevant to helping people with T1D exercise safely and effectively, and will encompass innovations in education, devices, and insulin management, among others.

Read more about this initiative and the grant recipients