Clinical Trial Data Transparency
Otsuka, as a company focused on innovation, recognizes that access to clinical trial data is valuable for the advancement of public health and science. The benefits and associated responsibilities of broadly available clinical trial data are considerable, including wider communication of the safety and efficacy data for our medicines, awareness of how clinical trials are designed and conducted, and insight to the diseases on which we, and many others, are seeking to meet unmet medical needs.
Otsuka has been sharing clinical trial results and other clinical trial information through clinical trial registries on websites accessible to the public such as the clinicaltrials.gov and clinicaltrials.jp and through publication in peer-reviewed journals, and we will continue these efforts.
Otsuka is committed to providing researchers in the medical sciences with secure access to anonymized patient-level data for Otsuka-sponsored clinical trials. To ensure that a balance occurs between advancing science for public health and fostering innovation, and protecting the privacy of individual patients, we have established an independent review panel to evaluate the scientific merit of research requests for anonymized patient-level data for in-depth analysis.
Otsuka is also committed to providing open public access to summaries of clinical study reports, which are synopses of documents submitted formally to regulatory agencies. Otsuka will also seek to coordinate our efforts with regulators and involved pharmaceutical industry associations in order to provide clinical trial participants with secure access to summary trial results in a format that is easy for participants to access and interpret.
For additional information on how to request access to Otsuka clinical trial data, and on related policies and procedures, please refer to our dedicated Clinical Trial Transparency website, accessible through a link near the bottom of this page.
Otsuka’s policies and procedures are consistent with the July 2013 PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing. These principles seek to enhance public health through 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.
Please click on the following link to view the dedicated website on Otsuka clinical trial data:
Together we will work to maximize the benefits of greater transparency of clinical trial data for better health worldwide.