||Clinical trials will be listed for Takeda-sponsored Phase 1-4 interventional trials
supporting approved products as described below.
Commercially available new medicines or vaccines products that have received initial
marketing approval since 01 January 2005 as follows:
• US and EU approval.
• US or EU approval (when regulatory submissions in both regions are not planned).
• Japan approval (when US or EU regulatory submissions are not planned).
Clinical trials will also be listed for Takeda-sponsored Phase 1-4 interventional
trials relating to
terminated compoundsi.e., terminated for all indications, all
and all regions. Terminated compounds are unapproved medicines or vaccines
for which clinical development is completely terminated on or after 01 January 2014.
||Takeda will only share clinical datai.e., patient level data and/or supporting
clinical documents when it is feasible to anonymize the data
without compromising the privacy of trial participants. This may affect small clinical
trials of rare diseases or trials conducted in a very small, easily identifiable
patient population, which will be reviewed on a case-by-case basis. Prematurely
discontinued trials that have insufficient enrollment/exposure to warrant analysis
may not be listed. Interim data from completed or ongoing clinical trials will generally
not be shared.
In rare cases, information may be restricted by Takeda in order to protect commercially
confidential information (CCI) and intellectual property (IP) rights.
Takeda Consumer Healthcare products will not be subject to data sharing.
|When studies are listed
||Clinical trials will be eligible for listing once the above criteria are met and the primary manuscript has been accepted for publicationIn cases where publication
is not achieved or sought, trials will be listed within 2 years of trial completion..
Clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in Japan), new indications, combination products, or major formulation changes for products that received initial approval since 01 January 2005 will be eligible for listing after the corresponding regulatory approvals have been achieved.
Takeda will regularly update this list to add trials meeting the criteria. For in-scope trials that are not yet listed, Takeda will assess the feasibility of data provision as part of the review of enquiries.
|Additional conditions for data access
||Data sharing is constrained by the requirements of the informed consent obtained at the time each clinical trial was conducted. In general, new research conducted on shared data must assess the specific medicine, disease or objective that was assessed in the original trial. For Takeda clinical trials initiated after this policy is enacted, patients will be asked to give permission for broader research beyond the original trial, so that other research may be possible with these data.
Where data is subject to legal, contractual, or consent provisions that restrict
transfer to third parties, data access may be precluded.
Other practical constraints to providing access to the data may also preclude sharing.
|Datasets and documents provided
||Where available, the following anonymized patient level data and/or supporting documents
are provided for each clinical trial. Information/documents will not be translated
and in rare instances practical issues relating to redaction and availability of
non-English documents may limit sharing.
Raw dataset. This is the data collected for each patient in the
Analysis-ready dataset. This is the dataset used for Takeda’s analysis.
Protocols. This describes the objectives, design, methodology,
statistical considerations, and organisation of a clinical trial and information
about all amendments.
Annotated case report form. This is a blank case report form with
descriptions of the data collected and how they are described in the dataset.
Reporting and analysis plan. This describes statistical analysis
plans that include methods of analysis, procedures for data handling and data displays
(figures and tables) that Takeda used for the trial.
Dataset specifications. This is the meta-data which describes the
datasets e.g., variable labels, variable descriptions, code lists, formats.
Clinical study report. This is the report of efficacy and safety
data from the trial. It forms the basis of submissions to regulatory authorities
such as the Food and Drug Administration (FDA) and the European Medicines Agency
(EMA). Appendices which include patient level data are generally not included as
these data are provided in the datasets Takeda provides.
Documents will be redacted to protect personal data of trial participants, trial
personnel, and Takeda employees (consistent with applicable privacy laws/regulations),
and to protect Takeda’s CCI and IP rights when required. Takeda will not share case
narratives, documentation for event adjudication, imaging data (e.g., x-rays, MRI
scans, etc.), genetic data, or other information that Takeda considers may compromise
trial participant privacy.
||Takeda accepts enquiries regarding the availability of patient-level data from clinical
trials that are not yet listed on this site but are within the scope of Takeda’s
data sharing policies via the Enquiry Facility.
|Access to study documents without patient-level data
Takeda also accepts enquiries for clinical study report document-only access (consistent
with the above data sharing policies) via the Enquiry Facility.
|Review criteria for enquiries
||Enquiries for patient-level data and clinical study reports (documents-only) will
be reviewed to assess if they relate to clinical trials that are within the scope
of Takeda’s data sharing policies (as outlined above).
|Clinical study register