BACKGROUND
Otsuka recognizes 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.
More broadly, Otsuka is committed, consistent with the July 2013 PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing, to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with the principles of safeguarding the privacy of patients, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.
Clinical Trial Registration and Posting of Results on Public Web Sites
Otsuka is committed to registering clinical trial information and tabular study results on publicly accessible websites, such as ClinicalTrials.gov and clinicaltrials.jp for all Otsuka-sponsored phase I clinical trials in patients and all phase II-IV interventional and observational clinical trials. Clinical trials registered in these and other registries are searchable in the International Clinical Trials Registry Platform.
In addition, Otsuka is committed to posting clinical study report (CSR) summaries for all studies with patients included in marketing authorization submissions filed with US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on or after January 1, 2014.
Publication of Clinical Study Results
Otsuka is committed to openly providing information on Otsuka-sponsored clinical trials at scientific congresses and in peer-reviewed journals, regardless of the outcome of the trials. This information shall be disclosed by Otsuka in a manner that is consistent with good scientific practice.
Disclosure of Patient level data
Otsuka supports providing access to anonymized, patient-level, analyzable data sets from Otsuka-sponsored clinical trials to qualified investigators engaged in independent research based on generally recognized and accepted scientific methods. This access is contingent upon approval of the protocol for the investigator’s proposed study by an Independent Review Panel and completion of a data-sharing agreement fully executed by the investigator and Otsuka.
Otsuka is committed to consider sharing patient-level data filed with the US and EU medicines regulatory agencies on or after January 1, 2014. Access to other patient-level data for medicines approved in the US, EU and Japan or terminated programs will be evaluated on a case-by-case basis. To learn more about Otsuka sharing of patient-level data with researchers, click here.
Sharing summary results with clinical study participants
Otsuka will support regulatory agencies and industry associations to develop mechanisms to share easily understandable summaries with clinical trial participants.