Envision Pharma Group’s Regulatory Writer, Hiroko Ebina, updates EMWA on the status of disclosure of clinical trial results in Japan
In October 2018, Envision Pharma Group’s Hiroko Ebina, who is a bilingual Regulatory Writer based in our ProScribe KK Tokyo office, was asked by Dr Samina Hamilton of the European Medical Writer’s Association to prepare an article for the "Medical Writing" journal known as "MEW" (www.emwa.org).
Dr Hamilton is a chairperson of CORE (Clarity and Openness in Reporting: E3-based) Reference (www.core-reference.org) and Section Editor for the “Regulatory Public Disclosure” (RPD) section of MEW. She reports on RPD-related matters and commissions open-access articles.
The topic that Hiroko Ebina was invited to write about for the RPD section was "Clinical trial disclosure landscape and awareness in Japan”. This topic deals with public disclosure of clinical study results that may occur through clinical study reports (CSRs), synopses, tabular information, or publications that are made available to the public on websites of certain health authorities, pharmaceutical companies that sponsor such studies, study registries (eg, www.ClinicalTrials.gov in the US), or publishers of journals.
The invitation followed, in part, from Hiroko Ebina’s presentation at the Drug Information Association’s Global Annual Meeting held in Chicago, IL, in June 2017; entitled “Driving international awareness and use of regulatory writing guidelines: Case studies of the Clarity and Openness in Reporting (CORE) reference guidelines.”
She reported on a study to investigate awareness of CORE Reference in Japan. CORE Reference is an annotated user manual on the preparation of CSRs for regulatory marketing applications that meet global requirements based on the International Conference on Harmonisation’s E3 Guideline with relevance to the structure and content of CSRs.