News & Events

Category: News

Galapagos joins Vivli as its newest member

“We are delighted to welcome Galapagos as a member of Vivli and to be able to partner with them to manage requests received for their individual patient-level data from completed clinical trials,” said Rebecca Li, Vivli Executive Director.

The Galapagos mission is to develop transformational medicines in areas of high unmet need by combining internal with external science with the goal to add years of life and improve quality of life of patients across the globe.

At Galapagos, we believe that transparency of clinical study data promotes strong scientific research and advances science and medicine. Galapagos commits to ensure full compliance with all applicable laws and regulatory guidance and provides specific attention to the protection of personal data at study participant level.

For more information about the conditions for accessing Galapagos data, please visit their member page. For additional information about Membership in Vivli, learn more here.

Vivli 2022 Progress Report Published

We are delighted to share with you Vivli’s 2022 Progress Report, which highlights our milestones to date and plans for the year ahead.

We look forward to continuing to grow together in 2023 and beyond, as leaders in data sharing and transparency, working together towards our end goal of advancing human health.

 

 

Vivli Executive Director Rebecca Li to Speak at AI-Enhanced Clinical Trials Summit in Boston

Vivli’s Executive Director, Rebecca Li, will speak at the AI-Enhanced Clinical Trials Summit in Boston on December 8th for “Unlocking Sensitive Healthcare Data To Optimize Clinical Trials And Encouraging Clinical Research Data Sharing.” Highlights will include the ethical and practical challenges of accessing patient data and how best to overcome shared challenges.

With drug development costs rapidly increasing, decision makers are right to be turning to novel AI/ML technologies to optimize clinical trial processes and de-risk drug development pipelines. Looking from both a patient-engagement and internal-process perspective, the AI-Enhanced Clinical Trials Summit takes a closer look at how available and scalable AI technologies are accelerating and improving clinical trials.

Learn more here.

Vivli webinar: “Applying the SAFE Data Standard to Securely Share Clinical Trial Data”

Vivli hosted a webinar to discuss applications of the SAFE Data Standard as defined in “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data.”

The webinar was held on November 29th, 4pm CET/10am EST/7am PST.

VIEW THE RECORDING

This one-hour webinar features authors of the recently published paper “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data,” presenting how data transformation is measured as part of the SAFE Data Standard and how to apply the SAFE Data Standard in different security contexts. This webinar is intended to help sponsors understand how to use the SAFE Data Standard to securely share rich clinical trial data to preserve data utility and for users of data to understand how accessing data in different contexts may change the utility of the data being provided.

Read the paper here!

Speakers include:
Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
Aaron Mann, CEO, Clinical Research Data Sharing Alliance

Moderated by:
Marcia Levenstein, Senior Advisor, Vivli

 

View the Recording of Vivli’s 2022 Annual Meeting

“Enabling the Data Sharing Ecosystem”

Vivli’s 2022 Annual Meeting was held on Wednesday, November 2nd, 2022, 9:00am – 12:00pm EST / 2:00  – 5:00pm CET / 10:00pm – 1:00am JST. This meeting served as a chance to allow Vivli data contributors, key collaborators and funders to discuss data sharing and its importance for furthering scientific discoveries.

View the Recording

Agenda

Welcome remarks
Vivli Update for 2022, Rebecca Li, Executive Director, Vivli

Sharing COVID-19 Clinical Trial Data on Vivli
Reflecting on best practices and current experience

  • Julie Holtzople, Senior Director Clinical Transparency and Data Sharing, AstraZeneca
  • Steve Kern, Interim CEO, Global Health Labs
  • Ben Rotz, Associate Vice President – Global Medical Policy Strategy and Operations, Lilly
  • David Leventhal, Enterprise Clinical Trial Data Sharing Lead, Pfizer
  • Rebecca Sudlow, Global Lead Patient Level Data Sharing, Roche

Q&A

NIH Data Sharing Policy Changes in 2023

  • Dr. Susan Gregurick, Associate Director for Data Science and Director of the Office of Data Science Strategy (ODSS), NIH

Q&A

Data Challenges
Spotlighting data challenges Vivli is embarking on with key partners in 2022-2023

  • Deniz Dalton, Program Officer, The Leona M. and Harry B. Helmsley Charitable Trust, presenting “Moving Type 1 Diabetes and Exercise Data to Solutions”
  • Tetsuyuki Maruyama, Executive Director, Alzheimer’s Disease Data Initiative (ADDI), presenting “ADDI/Vivli Data Challenge in Alzheimer’s Disease”

Next Steps and Discussion

Vivli Program Manager Catherine D’Arcy Speaks at DIA Global Clinical Trial Disclosure & Transparency Conference

Vivli’s Program Manager, Catherine D’Arcy, spoke at DIA Global Clinical Trial Disclosure & Transparency Conference on October 18th in Amsterdam, presenting “Clinical Research Data Use: Insights From Vivli’s Experience Of Data Sharing.” More than 140 delegates attended from 16 countries.

The 2022 Global Clinical Trial Disclosure and Data Transparency Conference builds on prior successful conferences to leverage learnings from regulators and international experts in the field. This event will provide essential, timely information about global clinical trial disclosure, data transparency, data sharing for secondary research, and the EU Clinical Trial Information System (CTIS) with the focus on transparency in relation to the protection of personal data and commercially confidential information. It brings leading study sponsors from industry and academia together with regulators and other players to exchange knowledge and share their experiences with the implementation of Clinical Trial Disclosure and Data Transparency from various viewpoints.

Vivli Senior Director Julie Wood Speaks at 19th Annual DIA Japan Annual Meeting 2022

Vivli’s Senior Director, Julie Wood, spoke at the 19th Annual DIA Japan Annual Meeting in Tokyo, Japan on October 11th for “Implementing Data Sharing in a Time of Pandemic.” The panel also included chair Azusa Tsukida, senior advisor to Vivli, and Dr. Oladayo Oyelola, Senior Director of Clinical Trial Information Disclosure at Daiichi Sankyo, Inc.

The theme of the 19th DIA Japan Annual Meeting is “New ‘Quest for the future’- Moving Creativity and Innovation Forward in ‘New Normal.’” Now that the world has experienced COVID-19, all will explore the future in a new normal environment. COVID-19 has brought about dramatic changes in our lives and activities. While face-to-face work declined dramatically, digital transformation accelerated quickly. This also promoted extremely rapid development of vaccines and therapeutic agents, as well as new clinical trial models including telemedicine. In addition, the importance of self-care associated with refraining from visiting medical institutions and the importance of addressing the issue of infodemics were reaffirmed.

NIDDK Central Repository joins Vivli to make its studies more discoverable and further scientific value

Vivli and the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), part of the National Institutes of Health (NIH), will be working together to broaden exposure and discoverability of NIDDK data. As part of Vilvi’s award to serve as one of six generalist repositories that will work with the NIH Office of Data Science Strategy under its Generalist Repository Ecosystem Initiative (GREI), NIDDK will include NIDDK Central Repository (NIDDK-CR) resources in the Vivli global clinical research data sharing platform.

“We are delighted to include large, multicenter NIDDK-funded studies on our platform as well as support other researchers directly who are funded by NIDDK,” said Rebecca Li, Vivli executive director. “Vivli is excited to partner with NIDDK to aid in the discovery of these valuable data sets and help to maximize research participants’ contributions.”

The NIDDK-CR is a contract-supported and centrally-managed repository that acquires, stores, and distributes resources generated from large, multicenter studies.

“NIDDK-CR’s inclusion within Vivli as part of GREI enhances NIDDK’s repository infrastructure and improves discoverability and reuse of NIDDK-hosted resources,” said Rebecca Rodriguez, Ph.D., NIDDK-CR program director. “It also provides opportunities to the NIDDK scientific community at large who share a common goal of building worthy data ecosystems under FAIR and TRUST principles for data management and digital repositories.”

For more information about the data NIDDK-CR will share on Vivli, please visit their member page. For additional information about Vivli membership, learn more here.

Vivli partners with The Helmsley Charitable Trust to share T1D exercise data

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program announced the launch of their initiative to support novel, real-world solutions to help people with type 1 diabetes exercise safely and to improve their quality of life. 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) and is now making the data from the studies publicly available with Vivli. To amplify its impact, Helmsley is also opening a request for proposals (RFP) for researchers, clinicians, and data scientists to analyze the data and test novel solutions in people with T1D.

“Vivli is delighted to facilitate access to these important data sets through a Helmsley grant, and to play a part in the advancement of T1D scientific research,” said Rebecca Li, Vivli Executive Director.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Read Helmsley’s full press release here.

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

Vivli team authors new publication in Health Data Science

The Vivli team, led by Executive Director Rebecca Li, recently authored a paper entitled “Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse.” This paper aims to raise awareness of the ecosystem of health-related data sharing platforms available for researchers to access high-quality data, and thus advance science by accelerating their scientific goals.

Vivli’s ultimate goal is to continue to grow our repositories (Vivli and the AMR Registry) to include more data available for reuse, to broaden the availability of data for researchers and raise awareness of these platforms amongst the scientific community to utilize these freely available valuable resources for their research.