News & Events

Reusing data from a completed clinical trial to inform guidelines

In a recent study led by Dr. Sarah Nevitt, a senior research associate at the University of Liverpool, a team of researchers examined the effectiveness of various antiepileptic drugs (AEDs) used as monotherapy for people experiencing seizures due to epilepsy. Epilepsy, a common neurological disorder, results from abnormal electrical discharges in the brain, causing recurrent seizures. Typically, around 60% to 70% of individuals with epilepsy achieve longer-term remission, often shortly after beginning treatment with antiepileptic drugs.

Dr. Nevitt and her team sought to compare the performance of 12 different AEDs in terms of treatment failure, remission, and occurrence of first seizures among both children and adults with focal onset or generalized tonic‐clonic seizures. They analyzed data from an extensive collection of clinical trials encompassing more than 22,000 participants, incorporating individual patient data from various studies using a network meta-analysis.

The analysis revealed some key insights. Older drugs like phenobarbitone and phenytoin demonstrated better seizure control for both focal and generalized seizures but had poorer long-term retention rates compared to newer medications such as lamotrigine and levetiracetam. Sodium valproate emerged as the top choice for achieving control and remission of generalized tonic‐clonic seizures, although it might not be suitable for everyone, especially people of childbearing age, due to associated risks.

These findings, published in the Cochrane Library, have already influenced the update of UK guidelines in 2022, providing immediate impact on the treatment of individuals newly diagnosed with epilepsy in the UK. In a recent conversation with Vivli, Dr. Nevitt highlighted that these results are guiding the approach to epilepsy treatment, emphasizing the importance of considering both efficacy and potential side effects when selecting appropriate medications for individuals experiencing seizures.

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.



AMR Data Challenge Grand Prize Winners are leveraging the power of AI to combat antimicrobial resistance more effectively

The World Health Organization (WHO) has identified Antimicrobial Resistance (AMR) as one of the top 10 global health threats facing humanity. Projections warn that antimicrobial-resistant infections have the potential to become the leading cause of death by 2050.

Recognizing the need for action on this pressing public health issue, Vivli joined forces with Wellcome in 2022 to launch the AMR Register. This innovative resource houses a growing collection of datasets shared by industry partners, offering consolidated access to surveillance data collected on dozens of antimicrobial interventions.

To raise awareness and encourage reutilization of this wealth of data, Wellcome funded the launch of the AMR Data Challenge in April 2023. The event offered a unique opportunity for multidisciplinary teams to access and leverage high-quality AMR surveillance data, and 56 teams from 28 countries submitted project proposals. The participating teams submitted a wide range of innovative proposals, making use of datasets contributed by GSK, Johnson & Johnson, Paratek, Pfizer, Shinogi, and Venatorx. 

Submitted proposals were assessed by a judging panel of international experts, who selected six outstanding proposals for recognition as winners of the AMR Surveillance Open Data Reuse Data Challenge. ​​The team that received the Grand Prize was led by Dr. Fredrick Mutisya, Health Data Scientist & Medical Doctor of Narok County, Kenya, and Dr. Rachael Kanguha, Pediatrician, Chuka County Referral Hospital, Kenya. 

Their groundbreaking work involved training machine learning models on the Pfizer ATLAS datasets and the development of a novel artificial intelligence web application capable of predicting antibacterial/antifungal susceptibility. Their proposal notes that traditional methods of prediction have proved insufficiently dynamic to cope with the growing amount of genomic data available, or to effectively monitor and predict trends in antimicrobial resistance, leaving gaps in researchers’ understanding and ability to respond. Their goal is to showcase the best predictive model in order to enable proactive measures and early detection of emerging resistance patterns, and provide a model for ethically and effectively integrating AI into an evidence-based epidemiology approach.

Dr. Mutisya expressed his team’s commitment to AMR and highlighted the importance of providing equitable data accessibility to scientists from his region:

“Our team feels incredibly privileged to have participated in such a meaningful data challenge. Winning the grand prize not only fills us with a profound sense of fulfillment but also ignites a stronger motivation within us to continue seeking solutions for global issues, especially in combating antimicrobial resistance,” he said. “We are deeply grateful to Vivli for providing a platform that facilitates data accessibility. This is particularly significant for scientists like us hailing from the Global South, where opportunities like these are often scarce.”

Five other teams, including scientists from Australia, China, France, India, Spain, the United Kingdom, and the United States, were recognized by the judging panel for proposals which demonstrated notable impact and innovation. A complete list of the winning proposals and finalists is available on the Vivli AMR platform

Members of the judging panel commented favorably on the excellent quality of the proposals submitted, the innovative approaches used, and creative solutions developed. One of the judges, Professor Marc Mendelson, also noted the importance of open access to data, calling it “a fundamental key to driving innovation towards a better understanding of AMR and the mitigation of this global health crisis.”

The Challenge is over for 2023, but the work of fighting AMR goes on. If you are interested in accelerating research and tackling a global public health challenge at the same time, explore Vivli’s AMR surveillance data sharing platform and find out how you can request access to data.

There’s more on Vivli than just clinical trial data

Did you know there’s more on Vivli than just clinical trial data? The majority of our repository of data comes from clinical trial data, but also includes significant numbers of platform trials, observational studies, and real-world evidence resources.

Vivli’s repository of data from nearly 7,000 research studies is available to search freely. Enter any relevant keyword and you’ll get a listing of pertinent studies of different kinds. Here are some recent search results using common keywords for studies that are not clinical trials: 

Observational: 198

Natural history: 26

Platform trial: 420

Explore our How To Guides to learn more about accessing and searching for data with Vivli. If you’d like to take your research further, you can get in touch with us for more information about specific studies or requesting access to data.

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. 



Public Disclosures

These tables provide details of approved research proposals that have published or presented their results.

How to Guides

Vivli provides the following resources to assist users of the Vivli Platform:

Data Request Guidance and Support

ResourceDescription
Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit a request for study data.Download PDF
Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
Vivli How To – Requesting StudiesHow to request studies through the Vivli platform.Download PDF
Vivli Data Request Quick Start (Video)A 3-minute video showing how to submit a data request.Watch video
Vivli Platform demo – How to search, request, and analyze data on VivliA short video showing how to request data on VivliWatch video
Vivli Lay Summary Training VideoHints and tips for completing your Vivli Lay Summary as part of your data request.Watch video

Download PDF
Vivli Data Request Form WorksheetWorksheet of information needed to complete a Vivli data requestDownload
Vivli Data Request Form Tips and TricksHints and tips for completing your Vivli Data Request Form.Download PDF
Data Request Form SampleExample of fully completed Data Request FormDownload PDF
Vivli Policies in BriefSynopsis of key policies governing interactions between researchers and data contributors during the lifecycle of a research proposal.Download PDF
Software and R Packages Available in the Research EnvironmentAnalytical and other software available in the research environmentDownload PDF

Study Submission Guidance and Support

ResourceDescription
Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit your study.Download PDF
Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
Vivli How To – Single study submissionData sharing instructional videoWatch Video
Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload
ICMJE Data Sharing RequirementsHow to use Vivli to meet ICMJE data sharing requirementsDownload PDF

NIH DMSP Guidance

Fill out the form below to access all the DMSP Guidance provided by Vivli.

    What best describes your current role?

    Do you plan to include Vivli in any future data management plans?

     

    Webinars, Publications & Presentations about Data Sharing

    VIVLI WEBINARS

    View Vivli’s webinars at your convenience by clicking on the links below:

    DateWebinarSpeakers
    April 2023Recent Developments in Data Privacy Laws and their Impact on Data SharingRebecca Li, Vivli
    David Peloquin, Ropes & Gray
    Katherine Wang, Ropes & Gray
    February 2023Submitting Your NIH Data Management and Sharing Plan using VivliAnne Seymour, Johns Hopkins University
    Amy Nurnberger, Massachusetts Institute of Technology
    John Borghi, Stanford University
    Rebecca Li and Julie Wood, Vivli
    November 2022Applying the SAFE Data Standard to Securely Share Clinical Trial DataLuk 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
    October 2022Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologiesLuk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
    Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB

    Moderated by:
    Aaron Mann, CRDSA CEO
    June 2022How Vivli Promotes Discoverability of Partner Platforms and RepositoriesIshwar Chandramouliswaran, NIH
    Dawei Lin, ImmPORT
    Ida Sim, UCSF and Vivli
    June 2021Sharing Academic Clinical Research DataIda 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 2021Clinical Trial Data Sharing and Machine Learning ResearchIda Sim, UCSF and Vivli
    Abigail Gregor, Ropes & Gray
    Daniel Freshman, Ropes & Gray
    September 2020Synthetic Data: How to preserve privacy of participants when sharing clinical dataPatrick Cullinan, Bluebird Bio
    Khaled El Emam, Replica Analytics
    Michael Lesh, Syntegra
    July 2020Accelerating Science in the Age of COVID-19: Three Key Data InitiativesRebecca 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
    Niamh McGuinness
    February 2020Future Directions: Real World Data, Real World Evidence and Clinical TrialsDr. Ida Sim
    Marcia Levenstein
    Dr. Gregory Pappas
    Dr. Jack Mardekian
    November 2019Credit for Data SharingDr. Barbara Bierer,
    Ms. Heather Pierce
    October 2019Why Data Sharing and Data Standardization MattersMr. David Bobbitt MSc, MBA
    Dr. Ida Sim, MD, PhD
    Dr. Rebecca Li
    May 2019Top five questions small and mid-size companies should ask before embarking on a data sharing programDr. Rebecca Li
    March 2019 Keys to Submitting a Quality Research Proposal to a Data Sharing PlatformMs. 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 2019How to Share and Request Data on VivliDr. 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

    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 SummariesJulie Wood
    Rebecca Li, PhD
    May 5, 2021"Data Sharing in a Time of Pandemic", a webinar with Front Line GenomicsRebecca 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 NetworkRebecca Li, PhD
    March 26, 2021"Acceleration of Research and Implications for Research Transparency." Center for Biomedical Research Transparency Summit SeriesIda Sim, MD, PhD
    January 19, 2021"Data Sharing of Rare Disease Data – Challenges and Rewards." PHUSE Data Transparency Winter MeetingRebecca Li, PhD
    December 11, 2020 "Vivli: A Global Clinical Trials Data Sharing Platform." dkNET webinarIda 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 ConferenceRebecca Li, PhD
    August 18, 2020"Platform Analytics Tools to Support Rare Disease Drug Development." FDA convening hosted by the Duke-Margolis Center for Health PolicyRebecca 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 WorkshopRebecca Li, PhD
    October 10, 2019 "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." Clinical Data Interchange Standards Consortium WebinarIda 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 RoundsRebecca 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 WorldRebecca 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 KongRebecca Li, PhD
    March 27, 2019“Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
    January 30, 2019“The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PAJulie Wood
    Thomas Wicks (TrialScope)
    October 25, 2018 "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, LondonRebecca 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 CAIda Sim, MD, PhD
    November 17, 2017 “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TXIda Sim, MD, PhD

    FAQs

    Please see below for frequently asked questions regarding Vivli, including the general features of the Vivli Platform. For more specific questions, including any questions regarding a specific data request, please review the Vivli resources section for more detailed guidance or contact Vivli User Support directly at support@vivli.org.

    Getting started with the Vivli platform

    What license do I need to use to participate in the Vivli platform?

    No license is needed. All users sign a Data Use Agreement specifying terms for use and re-use of the data. The DUA is the product of extensive negotiation with the organizations that contribute data to Vivli, and as such, the agreement is non-negotiable. More than 85 institutions from 25 countries have already signed this agreement.

    Does Vivli comply with the General Data Protection Regulation (GDPR)?

    Yes, Vivli does comply with GDPR. Please see Vivli’s privacy policy.

    What support do you offer users?

    Vivli has a dedicated, responsive support team available to answer any questions and help you through the process of submitting or requesting data. At any time, you may contact the Vivli support team at support@vivli.org. We aim to reply within 1-2 business days. For additional information about Vivli support options, check out our blog post on the topic: How our team supports users on the Vivli platform.

    My organization is interested in becoming a member. How do I do that?

    We’re delighted you’re interested in becoming an institutional member of Vivli. Learn more information about how to become a member here.

    You do not have to be a member to request data using the Vivli platform. You can also share the data from your clinical research. You find out more about that by going to How to share data.

    How do I create an account and log in to the Vivli platform?

    Logging into the Vivli platform is easy! Check out our quick start guide to help you through the process.

    What are benefits of data sharing?

    • Funders are increasingly mandating data sharing. The Gates Foundation, Wellcome Trust and many others are requiring that Individual Patient-Level Data from research they fund is shared. In addition, the updated NIH Data Sharing Policy went into effect January 2023. For many funders, data sharing costs are an allowable research expense and maybe built into future grant proposals and billed to current grants.
    • Top journals such as the NEJM, BMJ, Lancet and other ICMJE journals require that the data sharing statement is made at the time of trial registration. Journals are publishing the data sharing statement at the time of publication.
    • Moral obligations (owe it to trial participants). We owe it to participants of clinical trials who have volunteered to take part in this research for their data to be leveraged to maximize scientific knowledge. Surveys show that most participants want their data to be shared if adequate safeguards are in place.
    • Increase citations. Sharing detailed clinical research data is associated with increased citation rate.

    What is the Vivli platform and how is it unique?

    Vivli is an independent non-profit organization launched in 2016. Vivli evolved from a project of The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) to enhance access to clinical trials data by promoting data sharing and transparency. In 2013, the MRCT Center and a diverse group of global stakeholders embarked on a mission to define, design, and launch an innovative platform solution for global clinical trial data sharing.

    Vivli’s mission is to promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing enterprise. Vivli serves to meet the needs of researchers in all parts of the clinical research ecosystem. For those requesting data, Vivli provides managed access to data from completed clinical trials around the globe and facilitates the ability to integrate data from existing platforms and data repositories. For those seeking to contribute data, Vivli provides a secure, flexible, and user-friendly platform to facilitate sharing clinical trial data with the research community.

    The Vivli platform provides access to anonymized individual participant-level data (IPD) or the raw data that is collected during a clinical trial. The clinical trials represented in Vivli are global and contributed by a diverse group of data contributors. By serving as a global trusted platform, Vivli increases the discoverability of available data in the wider research ecosystem, and increases the overall capacity worldwide for effective data sharing, aggregation, re-use, and novel analysis of valuable clinical research data to advance science and improve public health. The Vivli platform is a cloud-based platform that consists of a dynamic search engine, a data repository, and a secure research environment.

    For more information about Vivli and the Vivli platform, please visit our About page.

    What types of data are currently available through the Vivli platform?

    Vivli features data from completed interventional studies in a number of therapeutic areas for which anonymized Individual Participant-level Data (IPD) are available as well as data from observational studies.

    Requesting access to data

    What kind of requests are accepted on the Vivli platform?

    The purpose of the Vivli platform is to support research utilizing available clinical data leading to published analysis of a concrete scientific hypothesis. For more information about our members’ data sharing policies, please visit each member’s page on our website.

    How do I access data available in the Vivli platform?

    Users either can access the data by downloading it or have access to a remote desktop workspace in a secure virtual research environment. On the member’s page, a member will share if the data is available by download or within the research environment. Find out more about the secure research environment.

    Once I’ve submitted a data request, how long will it be before my request is approved and I have access?

    On average it takes a few months to access data in the Vivli platform, but the timeline will vary depending on the number of data contributors, the number of studies, and your availability to respond to comments. Learn more about the data request process here. Once the proposal is final, the Vivli member(s) will prepare the data for sharing and then upload data to the platform. Additionally, you may find it helpful to review our blog post: 10 tips and tricks for drafting a successful data request.

    Can I access studies not listed on the Vivli platform?

    You can use our enquiry form to ask about a study from one of our Members that is not listed on Vivli, or for any additional study information not included in the study listing. It’s important to note that users can only request studies from Vivli Members.

    How do I submit a request to access a particular study?

    More information about how to submit a request is available in our quick start guide as well as our how-to guide for requesting studies, found here in our How To Guides.

    How much does it cost to request data on the Vivli platform?

    Vivli is a non-profit entity supported by both data contributors and data requestors who contribute to the administrative costs of running the platform. Requesting data is free and available to everyone. Data requestors who request data that are accessed through the secure research environment are charged a nominal cost for use of the secure research environment after a specified period of time, learn more here about that cost.

    How can I find studies on the Vivli platform?

    The Vivli platform allows users to search through listed studies using three search methods:

    • PICO Search,
    • Keyword Search,
    • Quick Study Look-up

    For more information, see Searching for Studies on our website.

    Who can use the platform and request data?

    The search feature is open to all users. To request data, a researcher or team must first create an account on Vivli and submit a research proposal. You do not have to be a member to request data using Vivli.

    Please see our quick start guide on how to request data.

    What tools and software does Vivli provide for data analysis?

    As a Vivli user, you have access to a secure research environment, a virtual work-space within the Vivli platform, which contains a bevy of the most popular tools for statistical analysis and manuscript preparation, including SAS, STATA, R, Python, Jupyter, the Microsoft Office suite and a full set of tools and scripts (available on Secure Research Environment page linked above). If your preferred tools are not included in the standard set, the Vivli team may be able to add them for you subject to having the appropriate license and security requirements. Contact support@vivli.org for any questions related to the uploading of additional tools, data and scripts.

    Sharing data on the Vivli platform

    Can I embargo my data set?

    You can upload your data on Vivli before it is shared with others. The study would be listed on Vivli’s platform and would make note of the date when the study data will be available. Researchers can still request the data and it will be shared when the embargo period has ended.

    Can I delete data I contributed to the Vivli platform?

    You may update your data or request that your data is deleted by contacting the Vivli team at support@vivli.org.

    How long will Vivli store my research in the Vivli platform?

    At a minimum, Vivli will make data available for researchers for 10 years, unless they are contractually unable to do so. On an ongoing basis, Vivli evaluates its data holdings with regard to maintaining access and reserves the right to discontinue the distribution of a data collections when deemed appropriate.
    When materials are deaccessioned, the data are no longer publicly accessible at Vivli, although they may still be preserved in Vivli’s storage vault. Because digital files are assigned a persistent digital object identifier (DOI), the study description is still available to view, but is not searchable through Vivli. Web crawlers are instructed to ignore the descriptions (via the robots exclusion protocol).

    For more information about Vivli’s policy, please contact Vivli at support@vivli.org

    Does my data need to be related to a published article?

    No, the data you share does not have to be published. However, the data must be affiliated with completed clinical research. We can meet publication requirements by sharing underlying data.

    What is the maximum file size?

    Vivli data contributors can share files up to 500 MB. Larger sizes of up to 100T can be accommodated. If your file is larger than 1T, please contact Vivli Support at support@vivli.org.

    Does submission to the Vivli platform satisfy publisher requirements for availability of data?

    Yes. The Vivli platform meets ICMJE requirements which includes many of the leading journals. This blog provides sample language for how answer the questions about data sharing as part of the journal requirements.

    How do researchers discover my data in the Vivli platform?

    All data sets are assigned a unique Digital Object Identifier (DOI), which helps make data sets easily discoverable and easy to trace when cited.

    How is data reviewed or curated?

    Vivli offers curation of the study metadata through a process overseen by Cochrane. It also has specialist vendors who can help with anonymization. If you need help with anonymization, contact our support team at support@vivli.org to discuss your options.

    Is data shared on the Vivli platform public or private?

    Vivli offers a secure platform for storing data. The list of studies available via Vivli’s platform is public, however, users must request access to the data for a specific research proposal, and all requests must be approved before access is granted. For more information, see Share Data.

    How much does it cost to share my data on the Vivli platform?

    Learn about the the fee breakdown for sharing your data here: Share Data

    How do I share data on the Vivli platform?

    Learn more and how to share data on the Vivli platform.

    Our team is available to answer any questions you might have about the process (support@vivli.org).

    Who can share data?

    Any individual or group with clinical trial data who has permission to share that data can list studies for sharing on the Vivli platform. All data contributors must sign and conform to the Data Contributor Agreement.  For more information, please contact us at support@vivli.org.

    What kind of studies may data contributors share on Vivli?

    Data contributors may share all completed trials, including phase I-IV interventional studies and observational studies. Additionally, Vivli accepts qualified studies from any investigator, whether funded or sponsored by industry, an academic institution, or non-profit organization.

    Do I need to anonymize my data set prior to contribution to Vivli?

    Yes, Vivli will only host anonymized data in its system. To assist in this process, Vivli partners with d-wise and Privacy Analytics,  industry leaders in health data-sharing methods and technologies, data security and de-identification. Our partners offer anonymization services to individuals and organizations who wish to share clinical research data on the Vivli platform. For more information, contact support@vivli.org.

    What are the specific standardization requirements and file formats for datasets contributed to Vivli?

    Files contributed should be provided in a format that can be used by the standard statistical packages (SAS, STATA, Excel) used for analysis. Data sets are not required to be standardized; however, we highly recommend that data sets be made available in CDISC SDTM (Standard Data Tabulation Model) format to support the most efficient data aggregation, re-use, and sharing.

    What decisions over data governance should I make prior to making a data contribution in Vivli?

    See Share Data on our website.

    Partners and Funders

    Partners

    Vivli and Cochrane work together to use the Cochrane ontology to power the Vivli search. Clinical trials included or cited on the Vivli platform are annotated using the Cochrane PICO ontology and vocabulary, supporting discoverability of data and making it easier for researchers to access clinical trial data. Cochrane’s mission is to promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence.

    Cochrane PICO Vocabulary – Copyright ©2018 Cochrane. All rights reserved.
    Cochrane PICO Ontology – Creative Commons Attribution – NonCommercial-NoDerivatives 4.0 International License

     

    Instem is partnered with Vivli to lower the barriers trialists face when it comes to sharing clinical research data responsibly. Instem offers expert-led outsourced data anonymization services powered by industry-leading anonymization software, Blur™. We are committed to helping your organization protect patient data while expediting medical innovation. Learn more about Blur, or request a call with our experts if you’re ready to start an anonymization project.

     

     

     

     

    Vivli partners with DataCite to mint persistent digital identifiers (DOI’s) for studies shared on Vivli as well as for publications resulting from data sharing on Vivli. DataCite is a leading global non-profit organization that provides persistent identifiers (DOIs) for research data. DataCite’s goal is to help the research community locate, identify, and cite research data with confidence.

    As a member of DataCite, Vivli is included in the Re3 Data Repository.

     

     

    Microsoft is a key partner in the Vivli platform. The Vivli platform is built entirely on the Microsoft Azure cloud server, which provides unparalleled data security coupled with a truly global presence. Microsoft in Health is committed to empowering health systems of tomorrow with better analytics, improved collaboration, and safer devices for real impact and better health today.

     

    Vivli collaborates with Privacy Analytics, an industry leader in health data-sharing methods and technologies, data security and de-identification. This partnership offers anonymization services to individuals and organizations who wish to share clinical data on the Vivli platform. By collaborating with Privacy Analytics, Vivli is driving forward the use of emerging technologies to promote and enable clinical data sharing, with the goal of developing new discoveries to improve human health. For more information on services offered by Privacy Analytics to Vivli data contributors, please email contact@vivli.org.

    Vivli’s outside counsel for corporate, regulatory and intellectual property matters is Ropes & Gray LLP, a preeminent global law firm with broad expertise in digital health and research. Ropes & Gray provides Vivli legal services on a pro bono basis, illustrating the firm’s longstanding public service commitment.

     

     

    TrialScope and Vivli work together to provide an end-to-end solution for disclosure and data sharing. TrialScope is the global leader in clinical trial disclosure and transparency management technology, supporting 13 of the top 15 industry clinical trial sponsors worldwide. TrialScope provides proven solutions that optimize the efficiency of disclosure activities, maximize trial data transparency, and foster more informed, engaged patients through open research sharing. To learn more about TrialScope, visit TrialScope.com.  

     

    Funders

    Vivli is grateful for the financial support and partnership of the following organizations in helping us deliver our mission to promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing and analytics platform:

     

     

     

     

     

    If you are interested in supporting Vivli, please email support@vivli.org