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 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 Senior Advisor Azusa Tsukida spoke at Clinical Data Interchange Standards Consortium (CDISC) 2023 Japan Interchange Program on July 10.
Tsukida presented during the session on ‘Real World Data & Regulatory Presentations/Perspectives’. Her talk focused on the benefits of data sharing, using case studies from data contributors who are sharing high-quality data via the Vivli platform to enable access to researchers worldwide and contribute to scientific discovery.
CDISC works to develop and advance data standards to support transforming incompatible formats, inconsistent methodologies, and diverse perspectives into a coherent framework for generating clinical research data that is accessible, interoperable, and reusable. More than 80% of the data available in Vivli is formatted in the CDISC-SDTM standard.
Find out more about how you can request data from Vivli’s repository and help accelerate the progress of health research.
Vivli announced that its Board of Directors has promoted Rebecca Li to the position of CEO. Li previously held the position of Executive Director and has been with the Vivli since its founding when it launched as a project from the MRCT Center of the Brigham and Women’s Hospital and Harvard.
“Rebecca has overseen the extraordinary growth of Vivli from the start and we are excited that she will continue to lead Vivli through the next phase of growth as we aim to go even further in our mission to make clinical trial available for research. She has demonstrated herself to be an exceptional team leader and strategic thinker with a clear vision for how we will develop globally in the coming years,” said Dr. Michael Stebbins, Vivli’s Board Chair.
“I am privileged to lead Vivli and envision further expanding our successful platform technology into Europe and Asia as we enter our next phase of innovation and growth” said Dr. Rebecca Li.
Vivli was founded in 2018 as a non-profit organization that is currently the largest individual participant-level (IPD) data sharing platform focused on sharing clinical trial data serving the international research community.
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.
Learn how the Vivli repository is making it easier for scientists to share and access data, and how you can comply with the NIH’s data management and sharing policy (DMSP) to maximize the value of your research
The National Institutes of Health (NIH) has a policy in place to ensure that data generated by NIH-funded research is accessible to the scientific community starting on January 25, 2023.
Data should be made available as soon as possible or the acceptance for publication of the main findings from the final dataset but the latest date is the end of the award. Data sharing can be done through a variety of mechanisms, including NIH domain repositories or NIH generalist repositories. These can be open-access or controlled-access systems. One such controlled-access repository recognized by the NIH is Vivli, a generalist repository for sharing of clinical data for human research studies.
As a condition of their grant application, investigators are now required to prospectively plan for management of their data and preparing it for re-use, submit a data management and sharing plan (DMSP), and comply with the drafted plan. The NIH Data Sharing Policy (DSMP) encourages investigators to share their data in order to maximize the value of NIH research funds. But what exactly is a DMSP and how do you draft one for submission to the Vivli Repository? The DMSP is a set of principles and guidelines that outline the requirements for sharing data generated by NIH-funded research. It includes 6 major elements that were selected to ensure that the data is shared as widely and promptly as possible, to maximize the scientific and public health value of the research, while protecting participant privacy and confidentiality. To fill out the DMSP, decisions should be made about the choice of repository, how long the repository will hold/archive the data, whether special tools/software will be provided to access the data, whether consensus data standards apply or exist, whether controlled access will be required and the oversight management details.
To help investigators on their journey to fulfilling the NIH data sharing policy, we have created a list of all the other resources available on our website, including the DMSP template guidance and budget guidance specific to using Vivli to help you navigate the process. Vivli has a step-by-step guide to understanding each of these elements and items to consider when developing a DMSP. We also have a customizable DMSP exemplary language available for download and adaptation, which includes sample text as well as guidance on preparing and submitting a budget as part of the DMSP.
Fill out the form below to access all the DMPS Guidance provided by Vivli.
Vivli has recently released new features timed to the NIH policy launch including: branded portals for research programs / institutions; academic credit; streamlined process for data sharing and reporting for institutions.
In summary, the NIH encourages data sharing as part of its mission to advance biomedical research and to promote collaboration among scientists. Vivli is a non-profit organization that provides a platform recognized by the NIH for funded researchers to share and access anonymized clinical trial data in a secure and compliant way.
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.
View Vivli’s webinars at your convenience by clicking on the links below:
|April 2023||Recent Developments in Data Privacy Laws and their Impact on Data Sharing||Rebecca Li, Vivli
David Peloquin, Ropes & Gray
Katherine Wang, Ropes & Gray
|February 2023||Submitting Your NIH Data Management and Sharing Plan using Vivli||Anne Seymour, Johns Hopkins University
Amy Nurnberger, Massachusetts Institute of Technology
John Borghi, Stanford University
Rebecca Li and Julie Wood, Vivli
|November 2022||Applying the SAFE Data Standard to Securely Share Clinical Trial Data||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
Marcia Levenstein, Senior Advisor, Vivli
|October 2022||Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologies||Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB
Aaron Mann, CRDSA CEO
|June 2022||How Vivli Promotes Discoverability of Partner Platforms and Repositories||Ishwar Chandramouliswaran, NIH
Dawei Lin, ImmPORT
Ida Sim, UCSF and Vivli
|June 2021||Sharing Academic Clinical Research Data||Ida Sim, UCSF and Vivli
Dan Ford, Johns Hopkins University
Susanna Naggie, Duke University
Kim Serpico, Harvard T.H. Chan School of Public Health
Ara Tahmassian, Harvard University
|March 2021||Clinical Trial Data Sharing and Machine Learning Research||Ida Sim, UCSF and Vivli
Abigail Gregor, Ropes & Gray
Daniel Freshman, Ropes & Gray
|September 2020||Synthetic Data: How to preserve privacy of participants when sharing clinical data||Patrick Cullinan, Bluebird Bio
Khaled El Emam, Replica Analytics
Michael Lesh, Syntegra
|July 2020||Accelerating Science in the Age of COVID-19: Three Key Data Initiatives||Rebecca Li, Vivli
Elizabeth L. Ogburn, Dr. Barbara Bierer, COVID Collaboration Platform
Janice Chang, Cara Rinaldi, TransCelerate BioPharma, Inc
|April 2020|| Data Sharing and Data Anonymization: the Vivli-Privacy Analytics Partnership ||Rebecca Li
|February 2020||Future Directions: Real World Data, Real World Evidence and Clinical Trials||Dr. Ida Sim
Dr. Gregory Pappas
Dr. Jack Mardekian
|November 2019||Credit for Data Sharing||Dr. Barbara Bierer,
Ms. Heather Pierce
|October 2019||Why Data Sharing and Data Standardization Matters||Mr. David Bobbitt MSc, MBA
Dr. Ida Sim, MD, PhD
Dr. Rebecca Li
|May 2019||Top five questions small and mid-size companies should ask before embarking on a data sharing program||Dr. Rebecca Li
|March 2019|| Keys to Submitting a Quality Research Proposal to a Data Sharing Platform||Ms. Cynthia Holas,
Dr. Sonali Kochhar,
Dr. Georgina Humphreys,
Dr. Joe Ross,
Ms. Ginger Gamble, MPH.
|February 2019|| Informed Consent and Data Sharing ||Dr. Barbara Bierer ,
Dr. Rebecca Li ,
Mr. David Peloquin,
Dr. Stephen Rosenfeld
|January 2019||How to Share and Request Data on Vivli||Dr. Ida Sim, MD, PhD
|November 2018|| IPD Meta-Analysis Webinar || Dr. Sarah Nevitt
PUBLICATIONS ABOUT DATA SHARING
|Data Sharing Goals for Nonprofit Funders of Clinical Trials
Coetzee T, Ball M, Boutin M, Bronson A, Dexter DT, English RA, Furlong P, Goodman AD, Grossman C, Hernandez AF, Hinners JE, Hudson L, Kennedy A, Marchisotto MJ, Myers E, Nowell WB, Nosek BA, Sherer T, Shore C, Sim I, Smolensky L, Williams C, Wood J, Terry SF, Matrisian L
Data Sharing Goals for Nonprofit Funders of Clinical Trials J Particip Med 2021;13(1):e23011 doi: 10.2196/23011 PMID: 33779573
|COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
Li, R., von Isenburg, M., Levenstein, M. et al. COVID-19 trials: declarations of data sharing intentions at trial registration and at publication. Trials 22, 153 (2021). https://doi.org/10.1186/s13063-021-05104-z
|Timely access to trial data in the context of a pandemic: the time is now.
Li R, Wood J, Baskaran A, et al. Timely access to trial data in the context of a pandemic: the time is now. BMJ Open 2020; 10:e039326. doi: 10.1136/bmjopen-2020-039326
|Move clinical trial data sharing from an option to an imperative
|New NonProfit Aims To Bring Data Transparency To Researchers
|Sharing Health Data: The Why, the Will, and the Way Forward A Special Publication from the National Academy of Medicine
Whicher, D., M. Ahmed, S. Siddiqi, I. Adams, M. Zirkle, C. Grossmann, and K. L. Carman, Editors. 2021. Health Data Sharing to Support Better Outcomes: Building a Foundation of Stakeholder Trust. NAM Special Publication.Washington, DC: National Academy of Medicine.
|COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic
Kristina Larson, Ida Sim, Megan von Isenburg, Marcia Levenstein, Frank Rockhold, Stan Neumann, Catherine D'Arcy, Elizabeth Graham, David Zuckerman, Rebecca Li. COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic. Contemporary Clinical Trials. 2022.
|Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse
Rebecca Li, Nina Hill, Catherine D’Arcy, Amrutha Baskaran, Patricia Bradford, "Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse", Health Data Science, vol. 2022, Article ID 9768384, 3 pages, 2022
|May 10-11, 2021||"Considerations for Sponsors when using a Data Sharing Platform" and panel, "Balancing Sharing Results and Data Whilst Protecting Participants Data Privacy" at InformaConnect Clinical Data Disclosure, Transparency & Plain Language Summaries||Julie Wood
Rebecca Li, PhD
|May 5, 2021||"Data Sharing in a Time of Pandemic", a webinar with Front Line Genomics||Rebecca Li, PhD
|April 12, 2021||"Implementation of Data Sharing platforms and How Researchers are Utilizing these Platforms to Further their Research.", a webinar with the HRB-Trials Methodology Research Network||Rebecca Li, PhD
|March 26, 2021||"Acceleration of Research and Implications for Research Transparency." Center for Biomedical Research Transparency Summit Series||Ida Sim, MD, PhD
|January 19, 2021||"Data Sharing of Rare Disease Data – Challenges and Rewards." PHUSE Data Transparency Winter Meeting||Rebecca Li, PhD
|December 11, 2020|| "Vivli: A Global Clinical Trials Data Sharing Platform." dkNET webinar||Ida Sim, MD, PhD
|November 6, 2020||"Responsible Data-Sharing to Improve Research Integrity." European Medical Writers Association 2020 Virtual Symposium ||Julie Wood
|October 16, 2020||"Privacy Incoherence in Medicines: The Confluence of Corporate Trade Secret, Government Non-Transparency, and AI Mediated Erosion of Patient Privacy." Northeastern University's Center for Law, Innovation and Creativity Annual Conference||Rebecca Li, PhD
|August 18, 2020||"Platform Analytics Tools to Support Rare Disease Drug Development." FDA convening hosted by the Duke-Margolis Center for Health Policy||Rebecca Li, PhD
|April 24, 2020||"Sharing, Discovering and Citing COVID-19 Data and Code." National Library of Medicine (NLM) at the National Institutes of Health (NIH)|
|Ida Sim, MD, PhD
|February 11, 2020||"Vivli Clinical Research Data Sharing: Share. Discover. Innovate." NIH Workshop on the Role of Generalist Repositories to Enhance Data Discoverability and Reuse, Bethesda MD|
|Ida Sim, MD, PhD
|October 25, 2019|| “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon."DIA Future of Evidence Workshop||Rebecca Li, PhD
|October 10, 2019|| "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." Clinical Data Interchange Standards Consortium Webinar||Ida Sim, MD, PhD
Rebecca Li, PhD
|September 27 2019|| "Preparing for clinical trial data sharing and re-use: the new reality for researchers." NIH Collaboratory Grand Rounds||Rebecca Li, PhD
Frank Rockhold, PhD
|September 19, 2019||“The Vivli Experience in Sharing Clinical Trial Data Globally.”OHRP Exploratory Workshop: Privacy & Health Research in a Data-Driven World||Rebecca Li, PhD
|June 2019||“Symposium SY13: Data sharing and responsible conduct of research: sharing industry experiences as part of the research transparency environment."World Conference in Research Integrity, Hong Kong||Rebecca Li, PhD
|March 27, 2019||“Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CA||Ida Sim, MD, PhD
|January 30, 2019||“The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PA||Julie Wood
Thomas Wicks (TrialScope)
|October 25, 2018|| "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, London||Rebecca Li, PhD
|March 13, 2018||“Vivli: A Global Secure Data Sharing Platform for Participant-level Clinical Trial Data.” American Medical Informatics Association Summit, San Francisco CA||Ida Sim, MD, PhD
|November 17, 2017|| “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TX||Ida Sim, MD, PhD
Stan Neumann is the Senior Director of Technical Operations at Vivli, where he is responsible for the reliability, usability and functionality of Vivli’s technical platform and supporting members and researchers who use the system. He is also responsible for QA and information and security management.
Prior to joining Vivli, Stan was a project manager and business analyst for BlueMetal Architects, where he helped numerous clients, define a technical vision and then realize that vision through a rigorous application of modern engineering practices and outstanding development skills. Prior to BlueMetal, Stan was the Director of Engineering at Axceler, where he helped the company grow from a startup to one of the most respected creators of SharePoint tools in the industry
The Vivli Steering Committee comprises representatives from Vivli members. This group includes institutional data contributors from academia, governmental, industry, and non-profit organizations and meets regularly to discuss operational, governance, and policy issues.
The Vivli External Advisory Committee brings together a diverse group of influential leaders with a commitment to data transparency. These leaders provide knowledge and insights based on their experience and expertise in their respective fields on a broad range of issues related to governance, implementation, and strategic planning. This external perspective supports Vivli’s growth as an institution.
- Sergio Bonini, Italian National Research Council (CNR), Institute of Translational Pharmacology
- Jeffrey Drazen, New England Journal of Medicine
- Dave Evans, CDISC
- Nina Hill, Hill Scientific and Public Affairs
- Karmela Krleza-Jeric, Impact Observatory, MedILS
- Young-Joo Lee, Johns Hopkins University
- Bernard Lo, UCSF
- Joshua Mann, VHL Alliance
- Jan McGonagle, Amoskeag Health
- Vasee Moorthy, World Health Organization
- Brian Nosek, Center for Open Science
- Amy Nurnberger, MIT
- Jane Perlmutter, Gemini Group
- Larysa Rydzewska, MRC Clinical Trials Unit at UCL
- Lon Schneider, University of Southern California
- Carolyn Shore, National Academies of Sciences (NAS) Observer
- Karla Soares-Weiser, Cochrane
- Catrin Tudur Smith, Liverpool University
- Megan von Isenburg, Duke Medical Center Library and Archives
- David Vulcano, HCA Healthcare
- Daoxin Yin, Peking University, Health Science Center