High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey

<div><p>Introduction</p><p>International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported.</p><p>Method</p><p>Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.</p><p>Results</p><p>With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.</p><p>Conclusion</p><p>Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.</p></div

Incidence and contents of compensation cases of industry-initiated clinical trials in Japan.

<p>1 As many of the same protocols are conducted in multiple institutions, we cannot determine the total number of protocols. Reconstructed from the survey result reported in the reference No. 12.</p

名古屋大学アイソトープ総合センターに設置されたγ線自動測定・解析システムによる地質試料の中性子放射化分析手順と分析精度

A new gamma-ray counting and data processing system for non-destructive neutron activation analysis has been set up in Radioisotope Center in Nagoya University. The system carry out gamma-ray counting, sample change and data processing automatically, and is able to keep us away from parts of complicated operations in INAA. In this study, we have arranged simple analytical procedure that makes practical works easier than previous. The concrete flow is described from the preparation of powder rock samples to gamma-ray counting and data processing by the new INAA system. Then it is run over that the analyses used two Geological Survey of Japan rock reference samples JB-1a and JG-1a in order to evaluate how the new analytical procedure give any speediness and accuracy for analyses of geological materials. Two United States Geological Survey reference samples BCR-1 and G-2 used as the standard respectively. Twenty two elements for JB-1a and 25 elements for JG-1a were analyzed, the uncertainty are <5% for Na, Sc, Fe, Co, La, Ce, Sm, Eu, Yb, Lu, Hf, Ta and Th, and of <10% for Cr, Zn, Cs, Ba, Nd, Tb and U. This system will enable us to analyze more than 1500 geologic samples per year.国立情報学研究所で電子化したコンテンツを使用している