Drug Evaluation Committee 2012-14 Inquiries about Clinical Trials from Patients to Sponsors
Related classification：Recruitment of human subjects
Initial release date: 2012.08
Revised release date: March 2025
Question
Our company (a pharmaceutical company) is planning a clinical trial for a disease designated as intractable. This has been covered in newspapers and other media, and there is a possibility that we may receive direct inquiries from patients in the future. In that case, please let us know the range of information you would be willing to share with the patients. Is it possible to
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(1)Selection and Exclusion Criteria
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(2)Expected Entry Period
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(3)Period of observation
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(4)Name of the implementing medical institution near the patient's area of residence
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We believe that it is acceptable to provide information within the scope of information published on jRCT (Japan Registry of Clinical Trials), ClinicalTrials.gov, etc. when we receive an inquiry.
Therefore, if such information is publicly available, we believe it is acceptable to provide the information.
Reason for revision of opinion
We have reviewed the outline and guidelines in the Opinion and changed the text to simply state that information may be provided as long as it is public information.