|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 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||
|What information will be provided||The following anonymized patient-level data is provided in English for each trial, where available:
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:
|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|