Vivli - sporedata/researchdesigneR GitHub Wiki
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Vivli was founded in July 2018 with the mission to "promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise" [3].
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Vivli started off as a joint initiative between Harvard University and Brigham and Women's Hospital's Multi-Regional Clinical Trials (MRCT) Center in 2013. The organization's vision is to "advance human health through clinical research data sharing" while honoring and respecting the contributions of clinical trial research participants.
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Vivli is an important initiative in the movement towards open science and data sharing in health research. By providing a secure and efficient platform for accessing and sharing clinical trial data, Vivli contributes to the advancement of medical research, improving transparency, and fostering collaboration in the scientific community.
- Vivli uses a single Data Use Agreement (DUA) as a condition for acquiring data from its platform, ensuring standardized processes for data sharing. The organization absorbs the costs of de-identifying and anonymizing data for external sharing, removing financial barriers for researchers.
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Researchers must submit an online application, including a research proposal and conflict of interest disclosure. The proposals undergo review by an independent review panel managed by the Wellcome Trust. This panel evaluates the scientific merit of the requests before granting access to the data.
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Quality assurance is ensured through rigorous review processes and adherence to data standards. Researchers must agree not to redistribute or publicly post the data outside the Vivli platform.
Vivli supports various research activities, including:
- Epidemiological Studies: Investigating the distribution and determinants of health conditions.
- Clinical Outcomes Research: Analyzing the effectiveness and safety of treatments.
- Comparative Effectiveness Research: Comparing different medical interventions.
- Financial Barriers: Absorbs costs associated with data preparation.
- Operational Challenges: Simplifies data sharing through a standardized DUA.
- Underutilization of Data: Facilitates broader use of clinical trial data after initial analyses.
- Cost Absorption: Covers the costs of data de-identification and anonymization.
- Independent Review: Ensures scientific merit through an independent review panel.
- Standardized Agreements: Utilizes a single DUA for all data requests.
Vivli hosts a wide range of clinical trial data variables, including:
- Demographics: Age, gender, ethnicity, etc.
- Adverse Events: Data on adverse events reported during clinical trials.
- Laboratory Results: Blood tests, imaging results, etc.
- Clinical Information: Baseline characteristics, treatment details, outcomes, etc.
- Innovation: Access to a wide range of datasets can lead to new insights and innovations in medical research, potentially accelerating the development of new treatments and therapies.
- Efficiency: By reducing the duplication of research efforts, Vivli helps optimize the use of resources and funding in the research ecosystem.
- Transparency: Sharing clinical trial data promotes transparency in research, allowing others to verify findings and build on previous work.
- Collaboration: Vivli fosters collaboration among researchers, institutions, and industries, creating a more interconnected scientific community.
- Data Preparation: Focuses on standardized datasets, limiting custom data requests.
- Data Integration: Challenges due to variability in data formats and standards.
- Privacy Concerns: Ensures strict adherence to privacy regulations.
- Access Restrictions: Requires compliance with regulatory standards and independent review.
- CASE STUDY: VIVLI - Sharing Health Data
- Timely access to trial data in the context of a pandemic: the time is now.
- Efficacy of Biologic Drugs in Short-Duration Versus Long-Duration Inflammatory Bowel Disease: A Systematic Review and an Individual-Patient Data Meta-Analysis of Randomized Controlled Trials.
Academic and research institutions can access Vivli datasets by submitting a research proposal and completing necessary compliance and review processes.
Researchers must submit an online application, including a detailed research proposal and conflict of interest disclosure. Access to data is contingent upon independent review and approval, ensuring responsible data use.
[1] Grossmann C, Chua PS, Ahmed M, Greene SM. Sharing Health Data: The Why, the Will, and the Way Forward. 2023.
[2] Grossmann C, Chua PS, Ahmed M, Greene SM. CASE STUDY: Vivli - Sharing Health Data. National Academies Press (US). 2022.