Drug Evaluation Committee (5) Burden Reduction Expenses for Subjects
Related classification: Other
First published: December 2004
Question
Please tell us about the burden reduction expenses.
Currently, our SOP sets the burden reduction fee at 7,000 yen. Should the burden reduction fee be a flat amount?
Depending on the protocol, there may be other possible burdens to the patient besides transportation costs.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The final report of the "Study Group for the Smooth Promotion of Clinical Trials" proposed in 1998 states that "the burden on subjects should be reduced by paying expenses within the scope of social common sense, taking into consideration the various material and psychological burdens associated with participation in a clinical trial.
As for the amount, for example, the Government Medical Service No. 196 (July 2, 1999) states that "For the time being, the standard fee for clinical trials conducted at national hospitals and sanatoriums shall be 7,000 yen," and that "the standard fee for clinical trials conducted at national hospitals and sanatoriums shall be 7,000 yen. In "Commissioned Research at National Hospitals and Sanatoriums," Q&A No. 5 (July 1999), the answer to Q1 states, "When setting an amount other than 7,000 yen, we ask that it be set based on a specific rationale so that it can adequately respond to accounting inspections, etc. We believe that it is not limited to 7,000 yen.
However, it is necessary to consider an appropriate burden reduction cost from a socially accepted perspective so that this does not become a strong inducement to participate in a clinical trial.
Furthermore, the burden on subjects may vary depending on the nature of the clinical trial, so discussions with the sponsor are necessary.
We would like to add that, as stated in GCP Article 10, Paragraph 1, Guidance 1 (6) and Article 32, Paragraph 1/Section 2, Guidance 2 (1) (vi), materials regarding payment to subjects are subject to review by the Clinical Trial Review Committee.