Clinical trial information disclosure policy

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 IFPMA1 Principles of 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 JAPIC2) in accordance with applicable regulations.

In addition, Taiho is committed to preparing a database for posting the synopses of clinical study reports (CSRs) for Taiho-sponsored interventional trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan.

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, and/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.

4.Sharing Results with Patients Who Participate in Clinical Trials

Taiho will work with regulatory authorities to adopt mechanisms for providing lay summaries of clinical trial results to research participants consistent with the applicable regulations.

September 2019

[1] International Federation of Pharmaceutical Manufacturers & Associations

[2] Japan Pharmaceutical Information Center