Our Members

GARDP

About GARDP (registered under the legal name GARDP Foundation) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant bacterial infections.

By carrying out research and development and forging public-private partnerships, GARDP is ensuring that the right antibiotics are developed and reach the people who need them. We embed affordability, appropriate use and sustainability for high-burden countries and populations into R&D licensing so that new treatments reach the people who need them most.
How we share on the Vivli Platform Available studies will be listed on the Vivli Platform. Interested researchers can apply for access to anonymized clinical trial data through the Vivli Data Request Form. Anonymized data will be shared in a Vivli secure research environment.

GARDP’s full External Data Sharing for Secondary Research Use Policy can be found on our website.
Anonymization Standards GARDP uses qualitative and quantitative risk management practices to create anonymized datasets. GARDP’s guidelines for preparing anonymized data are aligned with privacy standards and industry best practices.

The following data protection strategies are utilized during GARDP’s data anonymization process:

  • Subject identifiers/numbers: replaced by a newly generated subject ID that is used consistently across the study dataset.
  • Dates: Removed, or replaced by relative study day or date offset
  • Other identifiers such as age, race, ethnicity, country, height, weight and BMI are evaluated and anonymized based on risk measurement.
  • Comments, free text, variables containing other personally identifiable information (PII) or linkable information, e.g. names, initials: Removed.
  • Additional data set elements: evaluated based on risk and may be anonymized as required to meet necessary risk thresholds to ensure the data is anonymized.
Studies Listed for Sharing GARDP intends to make the following types of data available for secondary research:

  • Interventional clinical studies, Phases 1-4 sponsored by GARDP.
  • Epidemiology/observational studies sponsored by GARDP.
Exceptions Policy exclusions for out-of-scope data or requests are listed in the Policy available here and include:

  • Any study with legal or regulatory constraints preventing data sharing.
  • Any study where data cannot be safely anonymized.
  • Studies where data is not in English or data is unavailable.
  • Studies for which informed consent for anonymized individual participants data sharing for secondary use was not formally given and for which it is not reasonably possible to obtain permission to share retrospectively.
  • Full clinical study reports.
  • Genetic and Imaging data.
  • Two GARDP-sponsored studies, as listed in the policy, remain or will become accessible via previously solutioned data sharing platforms and are out of scope of Vivli data sharing.
Questions or enquiries Please utilize Vivli’s Enquiry process for any questions.
When Studies are available for sharing GARDP anonymized clinical trial data from interventional trials will be available when all conditions below are cumulatively met:

  • At least 18 months after study is complete [defined as last participant last visit (LPLV)], and
  • Results are posted in primary register, and
  • The primary publication has been completed or is determined not to be pursued further, and
  • Regulatory approval is complete with the first Stringent Regulatory Authority (SRA) or it is determined by GARDP that no further regulatory activities will occur.

Data from Epidemiology/observational studies will be available when all conditions below are met:

  • At least 18 months after study is complete (defined as LPLV), and
  • Results are posted in primary register (e.g. EU’s CTIS or Clinicaltrials.gov), and
  • The primary publications have been completed or is determined not to pursue further.
Review Criteria for Data Requests GARDP will complete an internal data request review for each new request. This review includes, but is not limited to reviewing the research proposal, publication plan, applicable global laws and regulations, legal basis for sharing, data availability, business activities and legal contracts.
Additional Conditions for Access
  • Research teams must include a qualified statistician.
  • Researchers whose requests are approved will need to sign a Data Use Agreement.
  • Researchers must agree to acknowledge the GARDP donor(s) who funded the original research and GARDP as data contributor in the publication.
Data Request Review Process Data requests are first assessed by GARDP to establish if they are in scope based on the GARDP policy.

For proposals that are determined to be in scope of GARDP’s policy, GARDP will seek review from the independent research panel (IRP), available through Vivli, who will evaluate the scientific integrity and merit of the proposed research.
What information will be provided Upon approval, GARDP may provide the following types of data:

  • Anonymized study data sets (individual participant data – IPD).
  • Data dictionaries (if available).
  • Protocol and SAP (Redacted).
Access to study documents without participant-level data Requests for aggregated data, redacted protocols, redacted SAPs and redacted CRFs can be submitted via Vivli Data Request Form and will be considered for sharing.
Clinical Study Register or Website GARDP sponsored studies are registered in appropriate global registries as required by law (i.e. Clinicaltrials.gov, EU CTIS, Pan African Clinical Trials Registry (PA CTR), etc)
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