News & Events

Event: Shaping the next 10 years in data sharing: Building on the gains made and looking ahead to the next 10 years in advancing human health

Please join Vivli at the National Academy of Medicine in Washington, DC on November 16, 2023 in Washington, D.C. for a strategic meeting to collectively reflect on the seminal 2015 IOM report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk to see how far we have come and chart a course to meet the challenges and opportunities that lie ahead.

PROCEEDINGS RECORDINGS

Session topics will focus on the following areas:

  • Welcome by Victor J Dzau, NAM President
  • IOM Report – 2015 Recommendations and Challenges Ahead
  • The value of data sharing realized –Use Cases
  • Credit and incentivizing the academic culture
  • Key technologies that will influence data sharing (machine learning, AI)
  • Regulations and policies to promote data sharing and re-use
  • Shaping inputs and directions for the next 10 years

We look forward to welcoming researchers, data contributors, publishers, funders and other interested stakeholders to this event as we work together to set a direction for data sharing and develop an action plan for the next 10 years.

This event is free, but registration is mandatory. Please register as soon as possible, as in-person space is limited. Virtual attendees will be able to view and ask questions of presenters. For virtual attendees, participation in the breakout groups and direction setting sessions will be limited. Please email support@vivli.org with any questions.

Agenda

 

Dr. Robert Califf, FDA Commissioner, will address the meeting as the morning keynote speaker; and Dr. Monica Bertagnolli, Director of the National Institutes of Health (NIH), will join as the lunchtime keynote speaker on Thursday, November 16th. Dr. Bertagnolli’s lunchtime keynote presentation will be available to those participants attending in person.

Dr. Bertagnolli is the second woman to lead the NIH on a permanent basis. Previously, Bertagnolli served as Director of the National Cancer Institute and has served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. She has also contributed to multiple initiatives focused on transforming the data infrastructure for clinical research.

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs in 2022. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute.

The 2015 IOM Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk Recommendations and Challenges ahead
Should we collectively set a new “north star” for the next 10 years?

Moderator: Bernard Lo, M.D., Professor of Medicine Emeritus, University of California San Francisco

  • Jeffrey M. Drazen, M.D. NEJM Group Editor, The New England Journal of Medicine
  • Professor Arti K. Rai, Elvin R. Latty Professor of Law, Duke Law
  • Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder
  • Joanne Waldstreicher, M.D., Independent Director, Becton Dickinson and Structure Therapeutics; Former Chief Medical Officer, Johnson & Johnson (retired); Faculty Affiliate, Division of Medical Ethics, New York University School of Medicine

The Value of Data Sharing Realized
This session will focus on real-life case studies that show the fruition of efforts to share data and its impact on science.

Moderator: Murray Stewart, M.D., Chief Medical Officer, Rhythm Pharmaceuticals, Inc., Vivli Board member

  • Ricardo Jorge de Oliveira Ferreira, Ph.D., Auxiliary Researcher at the Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL)
  • Richard Liwski, Chief Technology Officer and Director, Critical Path Institute’s Data Collaboration Center
  • Rebecca Li, Ph.D., CEO and co-founder, Vivli
  • Sarah Nevitt, Ph.D., Senior Research Fellow, Centre for Reviews and Dissemination, University of York
  • Ronald Summers, M.D., Ph.D., Senior Investigator, Imaging Biomarkers and Computer-Aided Diagnosis Laboratory, NIH Clinical Center

 

Credit and Incentivizing the Academic Culture
With the recent policy announcements by the White House and the newly updated NIH Data Management and Sharing Policy, movements are afoot to prompt academic researchers to share. What more can be done to encourage academic researchers to share their data by leveraging incentives?

Moderator: Barbara Bierer, M.D., Faculty Director, MRCT Center, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School; Director Regulatory Foundations, Ethics and Law, Harvard CTSA; Vivli co-founder

  • Elliott Antman, M.D., Director, Harvard Postgraduate Program in Clinical/Translational Science, Professor of Medicine, Harvard Medical School
  • Daniel Ernest Ford, M.D., M.P.H., Director & Professor of Medicine, Senior Associate Dean for Clinical and Translational Research, Johns Hopkins Institute for Clinical and Translational Research
  • Benjamin Pierson, Deputy Director, Enterprise Data, Bill & Melinda Gates Foundation

 

Key Technologies that will Influence Data Sharing (Machine learning, AI)
What role with key technologies such as Generative AI and other key technological advances play in data sharing? What are the key motivating factors and obstacles that will need to be addressed?

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

  • Joshua C. Mandel, M.D., Chief Architect for Healthcare, Microsoft; Lecturer on Biomedical Informatics, Harvard Medical School
  • Philip Payne, Ph.D., FACMI, FAMIA, FAIMBE, FIAHSI, Director, Institute for Informatics, Data Science and Biostatistics (I2DB); Chief Data Scientist and Associate Dean of Health Information & Data Science; Washington University School of Medicine in St. Louis
  • Jane Perlmutter, M.B.A., Ph.D., President and Founder, Gemini Group Consultancy

Regulations and Policies to Promote Data Sharing and Re-Use
Given recent shifts in national policies to promote data re-use as well as efforts by publishers to promote data reuse, what more can be done by regulators, national governments, publishers and other key actors to advance data sharing and subsequent re-use?

Moderator: Michael Stebbins, Ph.D., President Science Advisors. Vivli Board Chair

  • Steven Kern, Ph.D., Executive Director, Global Health Labs
  • Michael Lauer, M.D., Deputy Director for Extramural Research, NIH Office of the Director
  • Deven McGraw, J.D., M.P.H, LLM, Lead, Data Stewardship and Data Sharing, Invitae
  • Sharon Terry, M.A., Chief Executive Officer, Genetic Alliance

PROCEEDINGS RECORDINGS

Keynote speakers: Monica Bertagnolli, the NCI Director, and Robert Califf, FDA Commissioner, to present at the Vivli meeting at the National Academy of Sciences in November.

Vivli is delighted to announce the addition of two keynote speakers to the agenda for our upcoming event, “Shaping the next 10 years in Data Sharing.” Dr. Robert Califf, FDA Commissioner, will address the meeting as the morning keynote speaker; and Dr. Monica Bertagnolli, Director of the US National Cancer Institute (NCI), will join as the lunchtime keynote speaker on Thursday, November 16th.

“Dr. Bertagnolli and Dr. Califf have extensively advocated for data sharing and we eagerly anticipate their insights next month on this important topic,” said CEO Rebecca Li. “We are thrilled they will be joining us.”

Bertagnolli and Califf will join a range of distinguished presenters and participants including researchers, data contributors, publishers, patient advocates, funders, and other interested stakeholders gathering to reflect on the gains made in the past 10 years of data sharing and set new goals and plans for the future.

Dr. Bertagnolli’s lunchtime keynote presentation will be available to those participants attending in person. To be part of this conversation please make a plan to join us in Washington, DC on November 16. Registration is free, but spaces are limited – secure yours today!

Dr. Bertagnolli joined the National Cancer Institute as its director in 2022. Prior to that she served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. She has also contributed to multiple initiatives focused on transforming the data infrastructure for clinical research.

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs in 2022. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute.

REGISTER TO ATTEND IN-PERSON REGISTER TO ATTEND VIRTUALLY

Vivli CEO Rebecca Li to speak at the NIDDK Central Repository 20th Anniversary Workshop

Vivli’s CEO, Rebecca Li, will speak at the NIDDK Central Repository 20th Anniversary Workshop: Promoting Secondary Research to Accelerate Medical Breakthroughs and Innovation. This online event, hosted by the National Institute of Diabetes and Digestive and Kidney Diseases, will take place on September 19-20, 2023.

Li will participate as a panelist in a discussion session on ‘Supporting NIDDK-Funded Research and Expanding NIDDK’s Data Ecosystem’. This session will focus on real-world examples in which NIDDK-funded research is strengthening the data ecosystem and accelerating medical breakthroughs through secondary research, and is scheduled to run on Wednesday, September 20. NIDDK has been making data available to researchers in the Vivli repository since 2022.

The 20th Anniversary Workshop will review the NIDDK Central Repository program from its early beginnings to its current state, and engage a diverse range of experts from the research community to share experiences and explore future possibilities. Registration is open until Tuesday, September 19 – find out more and register on the event website

Vivli to host workshop at 2023 Cochrane Colloquium

Vivli will host a workshop at the 2023 Cochrane Colloquium in London on September 4. The Cochrane Colloquium is an annual event for Cochrane in support of its mission to promote evidence-informed health decision-making. 

Vivli’s workshop will focus on “Practical advice for accessing patient-level data from a data sharing platform for evidence synthesis.” This session will provide: 

  • an introduction to the Vivli platform, including an overview of data available and hands-on group work on how to submit a request for data
  • an overview of first-hand experience of using patient level data using Vivli’s data sharing platform as a case study 
  • a discussion session focusing on some of the opportunities and challenges associated with using patient level data (for example: what to do when data needed to answer the hypothesis is not available via a single data sharing platform?)

This session will be a mixture of hands-on practice and opportunities to hear from researchers who have used the platform, patient advocates, and data providers. There will also be time for participants to ask questions about the data access process. 

Vivli Senior Director Julie Wood will be joined by Alan Chant, the patient representative on the Independent Review Panel; Catrin Tudur Smith from the University of Liverpool; and Rebecca Sudlow from Roche to facilitate this workshop. 

For more information on the 2023 Cochrane Colloquium and to register for this session, please see the event schedule. Please note that participation in this session is open only to registered Colloquium attendees. 



Vivli celebrates publication of 200th public disclosure

Vivli celebrates 200 public disclosures

Vivli is delighted to announce publication of the 200th public disclosure resulting from the research team’s work with data from the Vivli platform. 

Rebecca Li, the Chief Executive Officer of Vivli, congratulates all the research teams who have utilized data from the Vivli platform to advance health research through the re-use of valuable clinical trial data. She also acknowledges the organizations, individuals, and thousands of trial participants who have generously shared their data, making this milestone possible.

The Vivli repository houses data from nearly 7,000 trials,  representing the contributions of 1.8 million clinical trial participants. On average, Vivli public disclosures are cited approximately 2.2 times per publication and appear in a wide range of highly-ranked academic journals. 

For more information about how to share and re-use data on the Vivli platform, please visit our Resources page.



Breaking News — Vivli announces the AMR Surveillance Open Data Re-use Challenge, funded by Wellcome, EOI due June 30

Vivli has launched the Vivli AMR Surveillance Open Data Re-use Challenge, funded by Wellcome. The data challenge aims to stimulate and support the innovative re-use of antimicrobial resistance (AMR) surveillance data available in the AMR Register.

This Challenge provides an opportunity for multidisciplinary teams to win prizes by using high-quality industry AMR surveillance data to answer pressing research questions. The data will be shared through the AMR Register.

A series of prizes can be won by research teams from any discipline who find new insights in the data and contributes to the fight against antimicrobial resistance.

What prizes can be won?
There are five monetary awards:
• Grand Prize Award – $20,000
• 4 awards – $10,000 (each) in the categories of Innovation and Impact

Winning teams will additionally be provided with funding towards expenses for ECCMID 2024 if an abstract is accepted.

Sign up to the data challenge Slack Channel to be notified when the challenge is open and to keep updated about the latest information and details about this data challenge.

What’s involved?
Teams are invited to register and submit a short summary of the research they intend to undertake with the data (and Expression of Interest or EOI) by May 10. The EOIs will be reviewed and teams will be given access to the data for a 30-day window, during which solutions must be submitted.

These submissions will be reviewed by a panel of judges and finalists selected. Finalists will have the opportunity to pitch their idea to a panel of judges via Zoom and the prize winners will be chosen.

Winners will be invited to submit a project abstract to ECCMID 2024.

T1D exercise data RFP from Helmsley Charitable Trust due the end of this month

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program has launched an initiative to support innovative and practicable solutions to help people with type 1 diabetes (T1D) exercise safely and to improve their quality of life. To help address knowledge gaps about the effect of exercise on T1D, Helmsley supported a research collaboration centered on two large observational exercise studies in people with T1D: one in adults (T1-DEXI) and one in children (T1-DEXIP). More than 500 people took part in the adult study, and another 250 in the pediatric study. Both studies were recruited and conducted fully remotely by design, enabling full monitoring and data collection which was unimpeded by COVID-19 pandemic restrictions.

The data from these studies include information about types of physical activity, heart rate, insulin use, CGM, diet, and genetics. The research collaboration collected and organized the observational data to maximize interoperability, and Helmsley has partnered with Vivli to make the data from T1-DEXI and T1-DEXIP publicly available. Sharing study data publicly will enable a range of researchers to access and explore the data from a variety of perspectives and research specialties.

In addition to facilitating public access through the Vivli platform, Helmsley has also opened a request for proposals (RFP) to support researchers, clinicians, and data scientists interested in analyzing the data and testing novel solutions in people with T1D. The RFP aims to fund projects that will improve the understanding of how exercise impacts T1D and that will provide people with T1D and their healthcare providers practical management solutions and clinical guidelines. The overarching purpose of this initiative is to move real-world data towards real-world solutions.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Researchers interested in exploring the T1D dataset on Vivli in order to prepare concept notes for submission can search data publicly available through Vivli’s search portal, and submit a data request using the standard process. Complete information about the RFP, including key dates and submission criteria, is available on The Helmsley Charitable Trust site.

Deniz Dalton, Program Officer in T1D at Helmsley, said, “People with T1D face many burdensome challenges in their daily lives, including complex decisions around exercise, diet, monitoring glucose levels, and administering insulin. We are excited to make this data publicly available and to launch this RFP, to advance the understanding of how exercise affects glucose management, and ultimately to help create real-world solutions to challenges faced by people with T1D around exercise.”

For more information, please watch Dalton’s presentation on this initiative at the Vivli 2022 Annual Meeting, or contact Vivli User Support directly at support@vivli.org with any questions

Vivli webinar: Recent Developments in Data Privacy Laws and their Impact on Data Sharing

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

The webinar was held on Monday, April 24th at 3pm CEST / 2pm BST / 9am EDT.

VIEW THE RECORDING

The People’s Republic of China (PRC) enacted a comprehensive data privacy law called the Personal Information Protection Law (PIPL) in November 2021. This law adds to an already complex data privacy framework in the PRC, which also includes the Regulation of Human Genetic Resources, the Biosecurity Law of the PRC and the Data Security Law of the PRC. This webinar will focus on key implications of the PIPL and these other PRC laws for the sharing of clinical trials data generated in the PRC for further research purposes. The speakers will also make comparisons between PIPL and the European Union’s General Data Protection Regulation (“GDPR”), another global privacy law that has had a significant impact on the sharing of clinical trial data.

Learning objectives for this session include:
• Understand the basics of PIPL
• Understand how PIPL affects sharing of clinical trials data across international borders
• Understand key differences between PIPL and GDPR

Speakers:
• Rebecca Li, Vivli
• David Peloquin, Ropes & Gray
• Katherine Wang, Ropes & Gray

This webinar is intended for organizations and individuals that share data and will be particularly useful for those who focus on data privacy.

VIEW THE RECORDING

Vivli Executive Director Dr. Rebecca Li Speaking at NIA-DUKE-Alzheimer’s Association Workshop

Rebecca Li will be speaking at the NIA-DUKE-Alzheimer’s Association Workshop held on March 15-16th sponsored by the National Institute on Aging.

The focus of the talk by Rebecca Li and Katherine Welsh-Bohmer (Duke University School of Medicine) is on how the Vivli platform can be used to access trials in Alzheimer’s Disease. Dr. Welsh-Bohmer will discuss the TOMMORROW trial – a large prevention study in Alzheimer’s Disease – as a specific use case.