News & Events

Vivli Researcher Spotlight: Assessing Clinical Trial Data on Cardiac Risk in Type 2 Diabetes Treatment

Dr. João Sérgio Neves is an endocrinologist, based in the Faculty of Medicine of the University of Porto and São João Hospital in Porto, Portugal. Dr. Neves’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Albiglutide and Cardiovascular Outcomes in Type 2 Diabetes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use”. The team’s completed research has been presented in publications including the Journal of the American College of Cardiology. Dr. Neves sat down with Vivli to tell us more about accessing individual participant data to advance his research, and the potential for combination therapy to reduce the risk of cardiovascular events in patients with Type 2 Diabetes.

Could you tell us a little bit about your research? What got you interested in the particular area of research that you carried out working with Vivli?

So I am a clinical endocrinologist; I do clinical research in the field of Endocrinology. I have a particular interest in the effects of endocrine diseases on cardiovascular risk and on cardiac function. My main areas of research have been obesity, diabetes, and pre-diabetes. Previous studies conducted by our team have explored the effects of GLP-1 receptor agonists in patients with diabetes, both with and without heart failure. One of the questions that was still unanswered from the literature was whether the benefits of GLP-1 receptor agonists were still observed in those that were already treated with SGLT2 inhibitors. These two classes of drugs are known to be protective from a cardiovascular perspective for patients with Type 2 Diabetes. However, the two classes were developed and the clinical trials were conducted in parallel. So when clinical trials of GLP-1 receptor agonists (AMPLITUDE-O trial and Harmony Outcomes study) were conducted a bit later and included participants that were already treated with SGLT2 inhibitors at baseline. The authors of the AMPLITUDE-O trial had already performed a sub-analysis evaluating the effects of the GLP-1 receptor agonists in patients treated with SGLT2 inhibitors. Given the relevance of further exploring the combination of GLP-1 receptor agonists with SGLT2 inhibitors, our group requested the Harmony Outcomes study from Vivli. The we also performed a meta-analysis combining the results of the Harmony Outcomes study with the results from the AMPLITUDE-O trial. So there are two trials that we included that evaluate the effects of GLP-1 receptor agonists and included some patients using SGLT2 inhibitors and we wanted to know if this data could help us understand if both drugs when combined can give further cardiovascular protection to patients with Type 2 Diabetes.

And having come to the conclusions that you did – that there may be further reduction in cardiovascular risk but that more clinical trials with combination therapy are required – have the findings from this made any impact in terms of research practice that you’re aware of, since the findings have become available?

So since the findings became available, there has been some interest from other doctors contacting us on how to interpret our findings. We are very cautious and we believe that further data and dedicated clinical trials are necessary to thoroughly evaluate this drug combination. However, acknowledging that these trials might take several years to be conducted, we also recognize that our existing data could assist physicians in making informed decisions about utilizing this combination in the interim. We believe that  the results of the Harmony Outcomes trial, in combination with the AMPLITUDE-O trial, favor the possibility that the combination of both drugs is protective from a cardiovascular perspective.

Interestingly, in the same month our paper was published in the Journal of the American College of Cardiology, the European Society of Cardiology published an updated guideline on the treatment of patients with Type 2 Diabetes and cardiovascular disease, and they recommended that patients with Type 2 Diabetes and cardiovascular disease should be treated with both drugs. They did not yet cite our paper because it was published just before publication of the guideline, but they do cite, for example, the AMPLITUDE-O trial. So I believe that our data will reinforce this recommendation; and we see that the field of treatment and prevention of cardiovascular disease in Type 2 Diabetes was already moving in the direction of our findings. But as there was only one study evaluating this combination, we think that our results will be very important for supporting the use of GLP-1 receptor agonists in combination with SGLT2 inhibitors.

Can you talk a little bit about using the data that was available through Vivli; what were you able to do using that data that you were not able to do otherwise?

The type of analysis we aimed to conduct could theoretically be performed using observational data. However, utilizing observational data poses significant challenges due to numerous confounders, particularly when assessing the effects of therapeutic interventions involving drugs. This limitation is well-documented, and such an approach would lack robustness, potentially raising more questions than providing answers. I think that the most interesting thing about the analysis that we performed was that this was a clinical trial that was already performed; the data was already available.

When we analyzed the data we worked with the authors from the primary paper; we got in contact with the authors of the primary analysis and we planned this analysis together. Our interactions with the original authors were invaluable in interpreting the data, given their familiarity with it. This collaborative effort resulted in an interesting analysis and yielded important results.

Can you talk a little bit about your experience of working with the Vivli platform – the processes and technology and what that was like?

I think that the process was quite easy, the instructions are clear. We know that there is always some type of bureaucracy that is involved, but that’s part of how it works, because we are dealing with data from patients. Of course it is anonymized data but I think that’s not different from what I was used to with other types of shared data. , The process works quite smoothly.

The thing that I feel that was a little bit different from our previous experience with secondary analyses, was the use of a platform for analyzing the data outside of our computers. Nevertheless, we successfully conducted our data analysis, and the data was also accessible within the remote computer, allowing us to execute the entire analysis seamlessly.

And how did you find out about Vivli and the opportunity to reuse shared data in general?

We had previously conducted analyses through the secondary analysis of existing data, utilizing platforms such as BioLINCC , which incorporates data from studies sponsored by NIH. Our awareness of Vivli stemmed from mentions in papers that disclosed their data sharing approaches, indicating that access could be facilitated through Vivli. This was my first personal experience using Vivli, and I must say that I find the work undertaken by the Vivli team truly remarkable. Your efforts contribute significantly to the future of research and the enhanced utilization of already collected data.

How has the direction of your own research been affected by the research that you did on this project? Has it affected what you’re doing or changed your direction in any way?

I believe it has provided clarity on the next steps to enhance knowledge in this field. In our team, we recognized that addressing whether the treatments were additive or not would be a pivotal question. If we discovered that the combination did not yield additional risk reduction, we needed to understand which drug to select for specific patients. With the results we obtained, our focus shifted towards understanding how to improve access to these drugs and assessing their effectiveness in other populations, particularly in the earlier phases of Type 2 Diabetes and even pre-diabetes. As we design new clinical trials, we are already incorporating the insights gained from this analysis.

Would you use the Vivli platform again? Are there any changes or improvements that you would recommend to how it works?

Certainly, the experience was highly positive, and I look forward to working again with Vivli in the future. One overarching improvement (that’s not specific to Vivli) would be to expand access to even more data. I do believe that the data is very valuable and that it is very important to share the data from large clinical trials. The type of study that we analyzed is probably the most relevant that should be shared – of course with a very specific and detailed analysis plan and with all the regulations that are needed in this context. Considering the substantial resources and time invested in these clinical trials, there is often a wealth of data that remains untapped. Many crucial analyses may not have been conducted and researchers not primarily involved in the clinical trial may be able to identify these questions and answer them using the data from that trial. Therefore, it is important to facilitate access to this valuable resource.

So my main recommendation is to try to increase even further the number of studies that are available. Of course this also depends on the companies that own the data and the drugs that are being evaluated. But our analysis could not be performed without the sharing by GSK, so we are also thankful for their contribution to Vivli and for the sharing of the data.

And is there any advice you would give to other researchers who are at the beginning of the process of requesting or using shared data?

My main advice is to have a very specific question that the researchers want to answer; develop a detailed analysis plan; and submit the request to the Vivli platform. While the process may take some time, it is not overly complex. With patience and adherence to the required steps, one can successfully obtain access to the data. I firmly believe that enhancing the utilization of the Vivli platform and increasing access to data from large clinical trials will significantly improve the quality of knowledge across various fields in medicine.

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.

Share NIH-Funded Data

Guidance for researchers on preparing a DMSP and sharing NIH-funded data

The NIH has updated its policies on data management and sharing (DMS). Effective January 25, 2023, the NIH DMS policy applies to most research funding by the NIH, and requires all applicants planning to generate scientific data to prepare a DMS Plan (DMSP) that describes how they will manage and share data. An effective DMSP requires thoughtful planning, preparation, and execution. We’ve compiled information and resources here to support every step of the process.

How to prepare a DMSP

The DMSP is a set of principles and guidelines that outline requirements for sharing data generated by NIH-funded research. It includes six major elements:

  1. A description of the data type
  2. Related tools, software, and/or code
  3. Common data standard that will be applied to the data
  4. Information about data preservation, access, and associated timelines
  5. Factors affecting access, distribution, or reuse of data
  6. Overview of how compliance with plans for management and sharing will be managed

The DMSP should also include information about direct costs required to support the activities outlined in the Plan.

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 DMSP Guidance provided by Vivli.

    What best describes your current role?

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

    How to choose the right repository to share your data

    To enable the implementation of the updated DMS policy, NIH has supported the establishment of the Generalist Repository Ecosystem Initiative (GREI). GREI is a collaboration of seven established generalist repositories who are working together to develop consistent standards and processes to facilitate sharing and reuse of data from NIH-funded studies. As part of preparing a DMSP, researchers will have the opportunity to review repository options and choose the one that best aligns with their needs. Vivli is part of the GREI initiative. The Vivli platform is the only GREI repository that focuses on sharing completed clinical research data at the individual participant level. To assist in considering these options, NIH has prepared guidance on selecting a data repository.

    Once your grant is approved – what next?

    How to submit studies to Vivli for data sharing

    If you’ve decided that Vivli is the right repository for your study data, great! We’ve developed a straightforward and efficient submission process, and we’ve got detailed guidance on how to submit your data and a checklist when you’re ready to begin the process to share your data.

    ResourceDescription
    Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
    Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload

    Further questions?

    Email Vivli at support@vivli.org and we will be delighted to assist you.

     

    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 – 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

      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 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

      Enquiries about Vivli Member Studies

      To enquire about a study not listed on Vivli or for additional study information not included in a study listing, please complete the below fields. To request multiple studies from the same Member, please list the all study IDs in the “Study ID” field. Please note you must enter at least one study in the Study ID field to submit your enquiry. If you have enquiries for multiple Members, please submit a new form for each Member.

      For more information on Vivli Members, please visit the Member Page. Some Members may require that enquiries be submitted via their own portals. Enquiries will be answered at the discretion of the Member. Please note that most members do not share studies where the primary completion date has not yet been reached.

      If a Member responds that a study is available, a data request will need to be submitted via the Vivli platform. In order to request access to study data, you must become a Vivli user. Additional information on how to get started is available in our resources section.


        Individual participant-level dataClinical documents (data dictionary, protocol, etc.)Summary-level data

        (e.d. Sponsor ID, NCT ID, Eudra CT ID) (Note: if you have multiple studies from the same data contributor, please list all study IDs)


        website is protected by reCAPTCHA v3

        Have a question and need to get in touch with the Vivli team? Contact us.

         

        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.

        Vivli Membership

        If you are from a for-profit organization and are interested in becoming a Vivli Member, please complete the following form and a Vivli team member will contact you directly. For academic institutions, find out more about the benefits of membership.

        Please note that you do not have to become a member to submit a data request using the Vivli platform. You can find out more about how to submit a data request by viewing our How to Guides.

        Join Vivli as a Member to benefit from our innovative, secure, and user-friendly global data sharing and analytics platform as well as the discoverability from listing your studies in Vivli’s search. Show your commitment as a leader in data sharing, and together we can drive forward scientific innovation and advance human health. 

        Membership in Vivli provides the following benefits: 

        • Be seen as a leader in data sharing: join other like-minded organizations as a member of the Vivli Steering Committee. 
        • Reduce your organization’s workload: Vivli will oversee requests about your data, while you take advantage of Vivli’s unified request process and agreements.
        • Increase discoverability: maximize the visibility of your clinical trials by including them in Vivli’s platform search.

        Members can choose to employ all or some of the benefits listed above.


          website is protected by reCAPTCHA v3