News & Events

T1D exercise data RFP from Helmsley Charitable Trust due the end of this month

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program has launched an initiative to support innovative and practicable solutions to help people with type 1 diabetes (T1D) exercise safely and to improve their quality of life. To help address knowledge gaps about the effect of exercise on T1D, Helmsley supported a research collaboration centered on two large observational exercise studies in people with T1D: one in adults (T1-DEXI) and one in children (T1-DEXIP). More than 500 people took part in the adult study, and another 250 in the pediatric study. Both studies were recruited and conducted fully remotely by design, enabling full monitoring and data collection which was unimpeded by COVID-19 pandemic restrictions.

The data from these studies include information about types of physical activity, heart rate, insulin use, CGM, diet, and genetics. The research collaboration collected and organized the observational data to maximize interoperability, and Helmsley has partnered with Vivli to make the data from T1-DEXI and T1-DEXIP publicly available. Sharing study data publicly will enable a range of researchers to access and explore the data from a variety of perspectives and research specialties.

In addition to facilitating public access through the Vivli platform, Helmsley has also opened a request for proposals (RFP) to support researchers, clinicians, and data scientists interested in analyzing the data and testing novel solutions in people with T1D. The RFP aims to fund projects that will improve the understanding of how exercise impacts T1D and that will provide people with T1D and their healthcare providers practical management solutions and clinical guidelines. The overarching purpose of this initiative is to move real-world data towards real-world solutions.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Researchers interested in exploring the T1D dataset on Vivli in order to prepare concept notes for submission can search data publicly available through Vivli’s search portal, and submit a data request using the standard process. Complete information about the RFP, including key dates and submission criteria, is available on The Helmsley Charitable Trust site.

Deniz Dalton, Program Officer in T1D at Helmsley, said, “People with T1D face many burdensome challenges in their daily lives, including complex decisions around exercise, diet, monitoring glucose levels, and administering insulin. We are excited to make this data publicly available and to launch this RFP, to advance the understanding of how exercise affects glucose management, and ultimately to help create real-world solutions to challenges faced by people with T1D around exercise.”

For more information, please watch Dalton’s presentation on this initiative at the Vivli 2022 Annual Meeting, or contact Vivli User Support directly at support@vivli.org with any questions

Vivli webinar: Recent Developments in Data Privacy Laws and their Impact on Data Sharing

Vivli held a webinar to discuss recent developments in data privacy laws and their impact on data sharing.

The webinar was held on Monday, April 24th at 3pm CEST / 2pm BST / 9am EDT.

VIEW THE RECORDING

The People’s Republic of China (PRC) enacted a comprehensive data privacy law called the Personal Information Protection Law (PIPL) in November 2021. This law adds to an already complex data privacy framework in the PRC, which also includes the Regulation of Human Genetic Resources, the Biosecurity Law of the PRC and the Data Security Law of the PRC. This webinar will focus on key implications of the PIPL and these other PRC laws for the sharing of clinical trials data generated in the PRC for further research purposes. The speakers will also make comparisons between PIPL and the European Union’s General Data Protection Regulation (“GDPR”), another global privacy law that has had a significant impact on the sharing of clinical trial data.

Learning objectives for this session include:
• Understand the basics of PIPL
• Understand how PIPL affects sharing of clinical trials data across international borders
• Understand key differences between PIPL and GDPR

Speakers:
• Rebecca Li, Vivli
• David Peloquin, Ropes & Gray
• Katherine Wang, Ropes & Gray

This webinar is intended for organizations and individuals that share data and will be particularly useful for those who focus on data privacy.

VIEW THE RECORDING

Projects at Vivli

Vivli works with many partners and funders to further its vision to advance human health through clinical research data sharing, to respect and honor the contributions of clinical research participants.

Independent Review Panel

An experienced independent consultant acts as the secretariat for the Independent Review Panel (IRP). Data contributors can choose to have an independent, neutral party oversee the review of requests by accessing the esteemed Independent Review Panel who will review research proposals based on their merit.

For more information, please review the Independent Review Panel Charter. Read more about the IRP members.

 

 

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)


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

     

    Our Members

    Please click on the logo of each member to find out more about how they work with Vivli. This includes a summary of their policies, approaches and procedures.

    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.


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      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