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Platform Life Sciences

About Platform Life Sciences is a global health research company experienced in developing and implementing adaptive, randomized platform control trials. Through strategic recruitment and innovative design, we lead some of the most sophisticated clinical trials in the world. We support transparency in research and value the insights that can be gained from responsible data sharing programs.
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 research environment.
Studies Listed for Sharing Data will be made available from clinical trials when the trial arm has been completed (or terminated after patients were enrolled) and the primary trial results have been published. Data sharing is subject to protection of patient privacy and respect for patients’ informed consent.
Exceptions Clinical trial data cannot be shared if:

  • Data cannot be anonymized or when there is a reasonable likelihood that the data could be used to re-identify a participant. This may include, but is not limited to, trials of rare diseases, trial arms with a small number of sites, or trial arms with a small number of participants. Trial arms that have insufficient enrollment to permit analysis may not be listed.
  • There are legal, regulatory, or contractual agreements in place that limit our ability to share the data with a third-party. Requests for such studies will be considered on a case-by-case basis.
  • The clinical trial informed consent process does not permit the sharing of anonymized data.

Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
When Studies are Listed Trial data will be eligible for listing once the above criteria are met and none of the exceptions apply.
Additional Conditions for Access
  • The research team has the qualifications and experience to conduct the proposed research (a biostatistician with a degree in statistics or a related discipline must be part of the research team).
  • Research teams must seek publication of their results in a peer-reviewed journal.
What information will be provided The following anonymized patient-level data is provided in English for each trial, where available:

  • Analysis-ready dataset. This is the dataset used for analysis.
  • Study protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of the clinical trial
  • Statistical methods. This describes methods of analysis and procedures for data handling
  • Dataset specifications. This is the meta-data which describes the datasets, e.g., variable labels, variable descriptions, code lists, formats

All clinical trial documents are redacted to protect the personally identifiable information of trial participants, as well as any commercially confidential information. All patient-level clinical trial datasets are anonymized to protect the privacy of trial participants.

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.
Review Criteria for Data Requests A feasibility assessment will be conducted for all enquiries based on the following criteria:

  • The studies are completed (or terminated after patients were enrolled) and the primary study results (and in exceptional circumstances key secondary results) have been accepted for publication.
  • Platform Life Sciences believes that the privacy and confidentiality of research participants can be protected through anonymization.
  • There are no ongoing regulatory or legal constraints on data sharing that would limit our ability to list the study and/or share the data.
  • The Research Proposal is compatible with study informed consent.
  • The data and studies are available to perform the analysis.
  • The planned analysis can be conducted in the data access system.
  • The data requested will be used to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health.
  • The proposed research plan (design, methods, and analysis) has the ability to meet the proposed scientific objectives.
  • There is a publication plan for the research.
  • There are no real or potential conflicts of interest that may affect the planning, conduct, or interpretation of the research and proposals. Such conflicts may relate to (but are not limited to) the research team, their institutions/ affiliations, or their relationships to independent review panel members and Vivli staff.
  • The research team has the qualifications and experience to conduct the proposed research (a biostatistician with a degree in statistics or a related discipline must be part of the research team).
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 and Platform Life Sciences 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   To prevent the re-identification of patients and to protect participants’ privacy, all direct patient identifiers are removed when anonymizing patient level clinical trial data and dataset documentation. Examples of direct identifiers include names, addresses, dates (e.g., birth date, date of hospitalization), biometric identifiers, contact information, and any other unique identifying numbers or characteristics. Any other information that can be used alone or in combination to identify an individual participant is also removed.
Clinical Study Register or Website https://www.platformlifesciences.com/clinicaltrials
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