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Otsuka

About Otsuka Pharmaceutical Co., Ltd. is a global healthcare company that researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue.

Otsuka Pharmaceutical Co., Ltd. and its subsidiaries, including Otsuka Pharmaceutical Development & Commercialization, Inc., (“Otsuka”) recognize that access to clinical trial data is valuable for the advancement of public health and science. In addition, Otsuka recognizes that it has an obligation to protect the privacy of clinical trial participants who have made a selfless contribution to the advancement of medicine. Otsuka assists qualified researchers to obtain patient-level clinical trial data while maintaining patient privacy. It uses the Vivli data sharing platform to benefit patients in the future.

Our driving philosophy at Otsuka is to serve those with unmet medical needs, and this is illustrated in our dedication to the central nervous system (CNS) space. In our 30 years of experience working in this therapeutic area, we continue to innovate and defy limitation by taking risks to overcome the complexities of treating mental health. We respect the value within every mind and are committed to making a difference in the lives of patients living with schizophrenia, major depressive disorder, bipolar disorder, and other CNS conditions.
How we share on the Vivli Platform Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request Otsuka’s data package(s). If the request is approved, researchers will need to sign a Data Use Agreement. The anonymized data and redacted documents will be provided in a secure research environment on Vivli to further protect participant privacy.
Studies Listed for Sharing Otsuka and its subsidiaries provide access to anonymized, patient-level and study-level clinical trial data (analysis-ready data sets) and other information (such as protocols and statistical analysis plan) from Otsuka-sponsored clinical studies in patients. Otsuka is committed to sharing patient-level data filed with the US and EU medicines regulatory agencies on or after January 1, 2014. Clinical studies will be listed on the website after regulatory approval(s). In addition to the studies listed on the Vivli platform, researchers are encouraged to contact Otsuka about the availability of clinical data for approved products in the US, EU, and Japan and for programs that have been announced by Otsuka as terminated.
Exceptions Otsuka will not share patient-level data when:

 

  • Risks for re-identification of patients are substantial or anonymization is difficult to achieve.
  • Clinical data were collected subject to legal, contractual, or consent provisions that prohibit or do not allow data sharing with third parties.
  • Planned publications of study results are accepted for publication.
  • Data sharing is not technically feasible (e.g., data or associated documents are not available in English, or are available only in an obsolete file format).
  • Disclosure is thought to pose substantial commercial competitive risks (e.g., on drug formulation development, pharmacokinetics, etc.).
  • Clinical data or documents are under regulatory review.
When Studies are Listed Otsuka is committed to consider sharing patient-level data filed with the US and EU medicines regulatory agencies on or after January 1, 2014.
Additional Conditions for Access In exceptional circumstances, access to data may be declined by the sponsor. For example, a potential conflict of interest, or a potential competitive risk.
What information will be provided Otsuka is committed to share anonymized, patient-level, analyzable datasets from Otsuka-sponsored clinical trials that are in scope. If available, the following data and documents will be provided for each clinical study:

 

  • Anonymized IPD
  • Full protocol with amendments
  • Statistical analysis plan
  • Data dictionary
Questions or enquiries For enquiries on availability of data of interest from Otsuka-sponsored clinical trials that are not listed on the Vivli site, researchers should fill out an enquiry form. Please note that patient-level data from clinical studies completed more than 10 years before the date of data request may be difficult to share due to data formatting or other technical reasons.
Review Criteria for Data Requests Completed Data Request Forms provided by Vivli are initially reviewed by Vivli for completeness. Once confirmed complete, Otsuka then reviews the completed Data Request Form.

In determining whether a specific request for access to data and clinical trial information shall be granted, Otsuka will consider the information required on the Vivli Data Request Form.
Data Request Review Process Data requests are initially reviewed by Vivli for completeness and other parameters. The data requests are then reviewed internally by Otsuka and are then reviewed by a fully independent review panel (IRP).
Access to study documents without participant-level data Researchers can inquire about access to clinical study documents only, such as the summary of clinical study report without patient-level data, by completing the Vivli online enquiry form.
Anonymization Standards   Our data anonymization and document redaction process ensure compliance with data privacy laws and regulatory guidance by appropriately de-identifying and anonymizing personal information of trial participants, while making every effort to preserve the underlying scientific content and integrity of the data. We will periodically review our processes to ensure compliance with data privacy laws and industry best practices.
Clinical Study Register or Website https://clinical-trials.otsuka.com/

April 2021        01US21EUC0023

 

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