Promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing enterprise.
Vivli will establish an independent general access electronic data repository and search engine through which individual participant-level data (IPD) and metadata from clinical trials conducted by researchers in academic, industry, foundation, and non-profit entities can be identified, hosted, shared and analyzed. Vivli will be agnostic to disease, country, sponsor, funder, and investigator, seeking to serve all elements of the international research community.
How Vivli works
Vivli has designed an enhanced search engine to index clinical trial metadata with machine-assisted curation. Vivli will take metadata information for datasets with available IPD from trial registry. This information includes details about where the data were generated and where it is hosted. We will enhance the registry information by extracting additional elements from the final study protocol documents. Using the population, intervention, comparator, and outcomes (PICO) elements extracted from the final protocol documents, Vivli’s search engine will allow precise query building that is superior to existing platforms. This will enable researchers to easily discover data relevant to their research question, regardless of where data are hosted. The robust metadata catalog will also support researchers interested in meta-analysis.
In partnership with data sharing leaders in industry, academia, patient organizations, government, and not-for profit organizations, we can achieve the Vivli vision to advance human health through clinical trials data sharing, thereby respecting and honoring the contributions of sponsors, funders, investigators and, most essentially, clinical trial participants.
By fostering collaboration and trust between industry, academia, and government institutions, Vivli will help science move forward and chart a new pathway that will accelerate progress in medicine.
Benefits to researchers
The Vivli platform will provide a secure and cost-effective environment to host academic clinical trials data for those who do not currently have reliable long-term options. Beyond storage and security, Vivli will also offer a host of services to suit academic research needs: controlled-access, data-sharing, open source analysis tools, dataset versioning, persistent data citations, and unique identifiers.
Vivli will work closely with data sharing leaders from the MRCT Center and academic institutions to promote data sharing by developing guidance and resources for researchers on anonymization, de-identification, and harmonization of data sets using common data elements. Leveraging the expertise and high-level engagement of the MRCT Center stakeholders and partners, Vivli supports the initiative to promote and incentivize data sharing through academic credit.
Benefits of submitting data
Clinical trials data sharing has great potential to accelerate scientific progress and to ultimately improve public health. Secondary analyses and aggregation of data can generate better evidence on the safety and effectiveness of therapies for patients without putting them at additional risk. Data sharing also allows health care professionals and patients to make better informed decisions regarding clinical care. Data sharing can enhance opportunities for exploratory research, which could lead to new scientific discoveries, more effective therapies, or alternative uses of existing therapies.
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) has been involved in efforts to enhance access to clinical trials data by promoting data sharing and transparency since 2013. MRCT Center and a diverse group of global stakeholders embarked on a mission to define, design and launch a solution to global clinical trial data sharing. With the launch of Vivli that vision is realized.