Study sponsor: Astellas
||Astellas sponsored Phase 1 to 4 interventional clinical studies in patients which have been completed after January 2010 and have been conducted for products and indications which have been approved in any country. Approval must have been granted by the agencies of the main regions US, EU and Japan. If approval is sought in only one or two regions, approval must have been granted by those agencies.
Clinical trials will also be listed for Astellas sponsored Phase 1-4 interventional clinical studies in patients relating to terminated compounds. Terminated compounds are unapproved medicines for which clinical development is completely terminated on or after 01 June 2015.
Astellas is in the process of compiling the list of studies and will regularly update this list to add studies.
||Clinical studies where data labels and/or supporting documents are not in English.
Small studies, single-center studies, clinical studies of rare diseases or other studies where anonymisation of these data is difficult to achieve.
Studies where clinical data have been collected subject to legal, contractual or consent provisions that prohibit transfer to third parties, or in case of substantial conflicts of interest, data access under this policy may be precluded.
For products where Astellas has a co-research, co-development or co-marketing/co-promotion agreement, it is recognized that the responsibility for disclosure is dependent on the agreement between parties. Astellas will endeavor to gain agreement to list studies in these circumstances.
Where use of the clinical data disclosure leads to commercial competitive risk.
|When studies are listed
||Once a product is approved for the given formulation in the given indication or the development is completely terminated and the results from the study have been accepted for publication, the study will be listed.
|Additional conditions for data access
||When patients agreed to take part in Astellas clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Astellas was researching. Further research must therefore relate to the medicine or disease that was researched in the original studies.
In rare cases, the limitations of the informed consent of study participants might not allow data sharing. In such cases, Astellas will try to address requests by providing summary data or otherwise.
|Datasets and documents provided
||Where available, the following anonymised patient level data and information is provided for each clinical study.
Raw dataset. This is the dataset collected for each patient in the clinical study.
Analysis-ready dataset. This is the dataset Astellas used for analysis.
Protocols with any amendments or addenda. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.
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.
Statistical analysis plan. This describes methods of analysis and procedures for data handling that Astellas used for the study report.
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 study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included.
Documents will be redacted to protect personal data of study participants, study personnel, and Astellas employees, and to protect Astellas' commercially confidential information, including intellectual property rights.
||Researchers can enquire about the availability of data from Astellas clinical studies that are not listed on the site before they submit a research proposal.
|Access to study documents without patient-level data
||Researchers can enquire about access to clinical study documents only (without patient level data, such as the Clinical Study Report) by completing the online enquiry form.
|Review criteria for enquiries
||Whether the studies have been published or accepted for publication and whether they researched authorized medicines or terminated compounds. It is Astellas policy to provide access to patient level data only after authorization or termination of the medicine and acceptance of the study for publication in the scientific literature.
Whether Astellas has the legal authority to provide the data. For example, Astellas may not have the legal authority because the medicine has been out-licensed to another company.
Whether Astellas considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
Whether Astellas considers that there are any practical constraints to providing access to the data.
The resources (costs) for Astellas to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and Astellas may turn down requests on this basis.
|Clinical study register
||Astellas currently registers all its interventional clinical studies in patients on ClinicalTrials.gov. Summary results are included on www.astellasclinicalstudyresults.com.