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.
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.
VIVLI WEBINARS
View Vivli’s webinars at your convenience by clicking on the links below:
PUBLICATIONS ABOUT DATA SHARING
 | 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 |
 | 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. |
 | 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. |
 | New NonProfit Aims To Bring Data Transparency To Researchers |
 | Move clinical trial data sharing from an option to an imperative |
 | 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 |
 | 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 |
 | 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 |
PRESENTATIONS
| 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.
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 Chief Operating Officer 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 and serves on the Steering Committee of CRDSA. 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.