VIVLI — Center for Global Clinical Research Data

Overview

VIVLI is an independent non-profit platform (founded 2016, Boston) that enables responsible sharing and reuse of individual patient-level data (IPD) from clinical trials globally, serving as a neutral, trusted intermediary repository between pharmaceutical companies, academic sponsors, and researchers seeking access to trial data for secondary analysis, meta-analysis, and replication studies. Rather than making data fully open (which risks privacy) or fully locked (which wastes research value), VIVLI implements a controlled-access model where researchers submit proposals and data contributors decide on a case-by-case basis whether to grant access through a standardised request and review process.

How VIVLI Works

For Data Contributors

Pharmaceutical companies, academic institutions, and foundations deposit anonymised individual patient datasets from completed trials. Contributors retain control: they set access conditions and review requests. Major contributors include Johnson & Johnson, Novartis, Pfizer, Roche, GSK, Sanofi, and multiple academic research programmes.

For Researchers

Researchers submit a research proposal describing the planned analysis. VIVLI reviews for completeness; contributors review for scientific validity. Approved researchers access data via a secure Enclave (cloud-based remote desktop). Data cannot be downloaded, only analysed in-place. Results and code can be exported after review.

Data Standards

VIVLI encourages CDISC SDTM/ADaM-formatted submissions (CDISC’s Study Data Tabulation Model and Analysis Data Model) and provides metadata harmonisation support for non-CDISC datasets. It is also exploring OMOP CDM harmonisation for federated queries across deposited datasets. Metadata uses controlled terminology from MeSH (conditions) and RxNorm (drugs).

Neurological Disease Datasets

VIVLI hosts datasets relevant to neurological disease research including Alzheimer’s disease trials (cholinesterase inhibitors, amyloid-targeting agents), Parkinson’s disease trials, multiple sclerosis disease-modifying therapy trials, and ALS (amyotrophic lateral sclerosis) trials.

Connections

• Interoperates with: CDISC (SDTM/ADaM), OMOP CDM
• Trial registry: ClinicalTrials.gov

Resources

• https://vivli.org
• https://vivli.org/members/ourmembers/ (VIVLI data contributors)
• https://vivli.org/resources/requestingdata/ (access request process)