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 email@example.com.
How did Vivli begin?
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.
What is Vivli?
Vivli is an independent nonprofit organization launched in 2016. 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.
What is the Vivli platform and how is it unique ?
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 diversity 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.
Why would a researcher wish to access data in Vivli?
Qualified researchers or teams may wish to request data through Vivli to conduct secondary analyses, test scientific hypotheses, assess reproducibility, conduct systematic reviews or reshape a trial in the planning stages.
What are the benefits of data sharing for contributors?
The culture of data-sharing is rapidly changing. Many funders currently require data-sharing plans and may consider the track record of research teams’ willingness to share data as a criterion for obtaining future grants. Leading academic journals also have the expectation that researchers make their data available and some require an independent review panel to decide how these data sets can be used. Importantly, data sharing will help science to move forward and chart a new pathway that will accelerate progress in medicine. For patients who have participated in clinical trials, sharing of clinical trial data is an important way to respect their contribution.
Is there a cost to request or share 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. 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 (typically after 12 months of continuous use). Data contributors who are interested in becoming an institutional member of Vivli, see Become a Member or contact us at firstname.lastname@example.org.
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 Data (IPD) are available.
Data Request Process
How can users search for studies on Vivli?
- The Vivli platform allows users to search through listed studies using three search methods, including a PICO Search, Keyword Search, Quick Study Look-up. Both the PICO Search and the Keyword search have advanced search options.
- For more information, see Searching for Studies on Vivli.
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.
What is Vivli’s “Secure Research Environment”?
Vivli’s secure research environment is a virtual work-space within the Vivli platform where researchers who have been provided access to data, will have remote desktop access to conduct their analysis. Researchers will have access to SAS, STATA, R, Python, Jupyter, and the Microsoft Office suite to enable analysis of shared data sets. If desired, additional analytical tools, data and scripts may be included in a research team’s secure research environment. Contact email@example.com for any questions related to the uploading of additional tools, data and scripts. The secure research environment provides researchers a customized space where their work is stored when in progress and allows team members to collaborate on the analysis.
Data Contribution Process
Who can share data?
Any individual or group with clinical trial data, who has permission to share the data, can list studies for sharing on the Vivli platform. All data contributors must sign and conform to the Data Contributor Agreement (available upon request). For more information, please contact us at firstname.lastname@example.org.
What kind of studies may data contributors share on Vivli?
Data contributors may share all completed trials, including phase I-IV interventional studies. Additionally, Vivli accepts qualified studies from any investigator, whether funded or sponsored by industry, an academic institution or non-profit organization. Documentation to accompany study data should be supplied in English.
Must the shared data be anonymized prior to contribution to Vivli?
Yes, Vivli will only host anonymized data in its system.
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. In the future, Vivli will explore the use of Common Data Elements within specific clinical domains.
What decisions over data governance should I make prior to making a data contribution in Vivli?
Datasets contributed to Vivli may be made available via various levels of access – through download (after signing of a Data Use Agreement) or alternatively data contributors may opt for their data to be made available via a secure access environment only. Additionally, data contributors may opt for data requests to be reviewed by an independent review panel through our partnership with the Wellcome Trust. To discuss options please contact us directly at email@example.com.