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.
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
Rebecca Li, PhD, is the CEO of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over 5 years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. She completed a Fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.
Julie Wood is the Senior Director at Vivli. She is responsible for Operations, including supporting members and researchers with data archiving, access and analysis on the Vivli platform. She is also a Co-Chair of the NIH Generalist Repositories Ecosystem Initiative (GREI) Coopetition Working Group. Prior to joining Vivli, Julie served as the Head of Communications and External Affairs at the Cochrane Collaboration. She has also worked for a Microsoft partner.
Ida Sim, MD, PhD is Professor of Medicine at the University of California, San Francisco and co-directs Biomedical Informatics at UCSF’s Clinical and Translational Sciences Institute. Dr. Sim earned her MD and her PhD in Medical Informatics from Stanford University, where her dissertation was on computational methods for data sharing of clinical trial results. She was trained in Primary Care Internal Medicine at the Massachusetts General Hospital, and completed fellowships in General Medicine and Medical Informatics at Stanford.
In 2005-6, Dr. Sim led the World Health Organization’s International Clinical Trials Registry Platform which established the first global policy on clinical trial registration and defined the common 20-item Trial Registration Data Set. She has led multiple NIH and other grants on “trial bank publishing,” ontology-based data sharing of human studies, and clinical trial visualization. Dr. Sim was a member of the 2015 Institute of Medicine committee on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.” She joined the MRCT Clinical Trials Data Sharing project in 2015 and is a co-founder of Vivli.
In other work, Dr. Sim is a national leader in mobile health and co-founder of Open mHealth, a non-profit organization building open APIs and tools for integrating mobile health data. She has served on multiple national advisory committees on health information infrastructure for clinical care and research. She is a recipient of the United States Presidential Early Career Award for Scientists and Engineers (PECASE), a Fellow of the American College of Medical Informatics, and a member of the American Society for Clinical Investigation. She is a practicing clinician.