Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation.

BACKGROUND: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders. METHODS: A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public. RESULTS: The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP's scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data. CONCLUSION: The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.

Surveillance of protocol deviations in Japanese oncology registration trials: a single institute experience.

Background The contents and requirements of study protocols vary depending upon each clinical registration trial. This study aims to describe details of protocol deviations in Japanese oncology registration trials. Methods We reviewed deviation reports that were discussed by the Institutional Review Board between 2010 and 2015. Results A total of 499 clinical trials were performed, from which 967 deviations were reported. In the initial 3 years, 445 deviations occurred in 535 ongoing trials, while 522 deviations occurred in 876 trials in the subsequent 3 years. The frequency of deviations related to visit, examination, treatment, and others was 189 (19.5%), 446 (46.1%), 275 (28.4%), and 57 (5.9%), respectively. Serious deviations were common at the time of registration of trials and during treatment. The deviations were attributable to the institution (n = 520), subject (n = 93), sponsor (n = 28), schedule management (n = 162), disease condition (n = 95), and others (n = 69). Conclusion This study showed the number and detail responsible factors of protocol deviations. Our findings support to distinguish between the measures to reduce the serious deviations and to reduce the overall number of deviations.

Clinical validity of the Japanese version of the Functional Assessment of Cancer Therapy-Anemia Scale.

GOALS OF WORK: The purpose of this study was to reveal the clinical validity of the Japanese version of the Functional Assessment of Cancer Therapy-Anemia scale (FACT-An) in relation to hemoglobin level. We also analyzed patients' scores for the related FACT-General scale (FACT-G), the FACT Anemia subscale, and the FACT Trial Outcome Index-Anemia scale (FACT TOI-An) to determine which was the most sensitive to anemia measurements. MATERIALS AND METHODS: Throughout Japan, we recruited 227 patients (mean+/-SD, 59+/-12.1 years old) diagnosed with a variety of cancers. We correlated the severity of anemia, as measured by hemoglobin levels, to scores on the FACT-An and on the other scales at baseline and at 3 months. MAIN RESULTS: The questionnaire completion rate was more than 98% at both time points. The FACT-An had high internal consistency (Cronbach's alpha coefficient >0.8). FACT-An scores were significantly and positively correlated with hemoglobin levels both at baseline (r=0.24; 95% CI=0.12 to 0.36; n=225) and at 3 months (r=0.24; 95% CI=0.10 to 0.36; n=204). FACT-G, FACT Anemia subscale, and FACT TOI-An scores also successfully discriminated between patients with lower (Hb <11.0 g/dl) and higher (Hb > or =11.0 g/dl) hemoglobin levels. Moreover, the changes of these FACT scores over 3-months could discriminate changes in hemoglobin level. CONCLUSION: The Japanese version of the FACT-An has higher clinical validity and can be used to appropriately assess health-related quality of life among Japanese cancer patients with anemia.