Taiho Group (Taiho) is committed to the transparency of Taiho-sponsored interventional clinical trials. Moreover, Taiho is committed to enhancing public health through responsible sharing of clinical trial data in compliance with IFPMA[1] Principles for Responsible Clinical Trial Data Sharing and other applicable transparency principles.
1.Clinical trial registration and posting of results on public web sites
Taiho is committed to registering information and summary results from Taiho-sponsored clinical trials in patients on public clinical trial registries websites (such as ClinicalTrials.gov or jRCT[2]) in accordance with applicable regulations.
In addition, regarding the medicine and the indication that has received marketing approval from regulatory authorities in the United States, European Union, or Japan after January 15, 2018, Taiho provides a list on Taiho’s website for the summaries of protocols and results for Taiho-sponsored interventional trials in patients in submitted to marketing authorization to regulatory authorities.
2.Publication of clinical trial results
Taiho is committed to publishing Taiho-sponsored clinical trial results from all Phase 3 studies and any significant medically important studies in peer-reviewed journals, congresses, or both, regardless of whether the findings are positive or negative.
3.Clinical trial data sharing
Taiho provides a platform for accepting researchers’ requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, or Japan on or after January 15, 2018.
Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.
To learn more about Taiho sharing of patient-level data with researchers, click here.
Update April 2021
[1] International Federation of Pharmaceutical Manufacturers & Associations