Q（Question）

When a patient organization requests information on the development status of unapproved drugs or new indications (clinical trial information), what types of information may the company provide?

A（MHLW answer）

For example, it is permissible to provide, in accordance with the conditions of this guideline, information from websites introduced on the Ministry of Health, Labour and Welfare website as sources of domestic clinical trial and clinical research information—namely: the University Hospital Medical Information Network (UMIN); the Japan Pharmaceutical Information Center (JAPIC); the Japan Medical Association Center for Clinical Trials (JMACCT); clinical research registered under the Clinical Trials Act in the Japan Registry of Clinical Trials (jRCT); the main clinical trials and humanitarian-use trials (expanded-access trials) published on the PMDA website; and information from ClinicalTrials.gov (https://www.clinicaltrials.gov/).

Items requiring particular attention: (4), (7)

So what (meaning): Companies may direct patient organizations to publicly registered trial databases (UMIN, JAPIC, JMACCT, jRCT, PMDA, ClinicalTrials.gov); they may not share non-public internal data or proprietary clinical results with patient groups.

So why (rationale): Restricting provision to publicly disclosed registries ensures that patient organizations receive unbiased and verifiable information, satisfying the fairness and completeness requirements in items (4) and (7).

Commentary — background, application, practical notes

This question parallels Q6—which covers clinical trial information requests from physicians and pharmacists—while extending the scope to patient organizations. Since patient organizations are not healthcare professionals and the guideline primarily governs information provision to healthcare professionals, this question is particularly important for defining the outer limits of permissible information provision to patients and the public.

What may be provided is restricted to information from publicly accessible databases maintained by authorized registries—UMIN, JAPIC, JMACCT, jRCT, PMDA, and ClinicalTrials.gov. When a patient organization asks about the development status of an unapproved drug or a new indication, the company may direct it to these public clinical trial registries in accordance with the guideline's conditions. Providing non-public internal data, proprietary clinical results, or details of the company's development strategy is not within the scope of this permission.

A common compliance failure arises when companies, motivated by a desire to be responsive to patient advocates, share non-public development updates or unpublished trial data with patient organizations. Patient organizations play important societal roles in disease awareness and policy advocacy, and companies often have strong collaborative relationships with them—but the regulatory boundary is clear: the scope of information provision to patient organizations is narrower than to healthcare professionals and is confined to publicly registered information. Because information shared with patient organizations may ultimately reach individual patients, the requirements for fairness and completeness (items 4 and 7) apply with particular force, warranting careful consideration of what is shared and how.