統一的な因果関係判定基準の提案
治験実施計画書の調査および担当医へのアンケート調査の結果より
2006 年 37 巻 3 号 p. 139-144
詳細
2006 年 37 巻 3 号 p. 139-144
To properly assess an adverse event as to whether or not it is causally related to a particular drug, the categories and definitions of the rating must be standardized, and the variability of the judgment by the physicians should be small. We surveyed the assessment of adverse events in 50 protocols of clinical trials and asked 77 physicians to determine the causality in two cases of adverse event. The category system of the rating was quite varied among the protocols and the inter-physician disagreement in the judgment was also large. Our survey showed that it is necessary to re-consider and standardize the category system and the definition of the causal relationship of adverse events and drugs.
