About |
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver 13 new treatments, saving millions of lives. |
How we share on the Vivli Platform |
Available studies will be listed on the Vivli Platform. Interested researchers can apply for access to data packages through the Vivli Data Request Form. Researchers whose requests are approved will need to sign a Data Use Agreement and anonymized data will be shared through Vivli’s secure data download. |
Studies Listed for Sharing |
Data will be made available from clinical trials when the study has been completed and the primary trial results have been published. Data sharing is subject to protection of patient privacy and respect for patients’ informed consent. |
Exceptions |
In some cases, DNDi’s datasets may be stored in other data platforms, such as IDDO. In those instances, Vivli will forward your data request to the appropriate platform for review and response. |
When Studies are Listed |
Typically within 1 month of the publication of the primary data from the trial. |
What information will be provided |
The following anonymized patient-level data are provided in English for each trial, where available:
- Anonymized IPD (raw data)
- Full protocol with amendments
- Statistical analysis plan
- Data dictionary (when available)
- Anonymization guidance
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Questions or enquiries |
Researchers may enquire about the availability of data from clinical trials that are not listed on the site before they submit a data request. Please use the Vivli Enquiry Form. All enquiries will be considered on a case-by-case basis. |
Data Request Review Process |
Researchers can request access to our listed studies by providing a scientifically valid research proposal with a commitment to publish their findings. Data requests are initially reviewed by Vivli for completeness and other parameters and are then reviewed by a fully independent review panel. |
Access to study documents without participant-level data |
Researchers can enquire about access to clinical study documents by using the Vivli Enquiry Form. |
Anonymization Standards |
Some or all of the following data protection procedures for personally identifiable information are performed by an appropriately qualified vendor prior to data sharing to protect the privacy of study participants.
- Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
- Further unique identifiers: Removal of identifiers such as kit numbers and devices.
- Site ID: Removed.
- Date of birth: Removed. Replaced with age at screening in most cases.
- Country: Aggregation to regional level where countries had only one study site.
- Dates/Times related to study participants: Date shift by random shift factor. Same factor for all dates of a patient, but different factor per patient. Time remains unchanged.
- Comments, freetext, variables containing personally identifiable information (PII), e.g., names and initials, are removed.
- Verbatim term of adverse events and medical history: Verbatim term replaced by coded dictionary terms.
- Verbatim term of concomitant medications: These are usually removed.
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Clinical Study Register or Website |
https://dndi.org/research-and-development/clinical-trials/clinical-trial-protocol-synopses/ |