Drug Evaluation Committee 2010-49 Provision of goods in lieu of burden reduction payment
Related classification: Other
First published: Apr 2011
Revised publication date: Mar. 2012
Question
We are currently considering the provision of goods to subjects as an alternative to the cost-sharing expense in our study being conducted overseas. In Japan, we are also considering whether or not to provide goods to subjects when considering participation in this global clinical trial.
Therefore, we would like to ask for your opinion on whether or not there is a problem with this matter under GCP, and if there is no problem, what points should we keep in mind when conducting the trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 10, Paragraph 1, Guidance 1 (6) of GCP, "Documents explaining the burden of costs of the clinical trial (documents related to payment to subjects (if any))," prior submission of documents to the head of the site is required regarding payment to subjects. Also, as stipulated in Article 32 of the GCP, deliberation by the Clinical Trial Review Committee is required based on the documents submitted in advance. In other words, according to GCP, there is no problem with the provision of money or goods to subjects as long as it is approved by the Clinical Trial Review Committee.
However, some items may be an inducement for subjects to participate in a clinical trial, so special attention should be paid to the appropriateness of the items provided by the medical institution.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Clinical Trials on Drugs," the commentary quoted in GCP Article 10, Paragraph 1, Operational Notification 1 has been changed.