Search

Background: Incomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan. Thus, using the European Clinical Trials Database (EudraCT), this study aimed to identify the factors related to the study design and administration that lead to incompletion of clinical trials that included pediatric patients.Methods: We focused on clinical trials that included patients under the age of 18 registered in the database, named as the European Clinical Trials Database between January 1, 2014, and December 31, 2018. Two groups of trials were identified: "all cases completed" and "not all cases completed," reflecting whether they were completed in all participating countries/regions or not. To identify the factors of the occurrence of "not all cases completed," a logistic regression analysis was performed to calculate the odds ratios and 95% confidence intervals. In total, 142 clinical trials (95 "all cases completed" and 47 "not all cases completed") were analyzed.Results: The logistic regression analysis showed the number of countries in which a clinical trial was conducted to be the only significant factor (odds ratio: 1.3; 95% confidence interval: 1.1-1.5); this was identified as the primary factor for the occurrence of "not all cases completed" in the clinical trials that included pediatric patients.Conclusion: Our findings suggest that the feasibility of clinical trials that include pediatric patients, such as whether the countries in which the trial is to be conducted are suitable, must be considered prior to the trial. [ABSTRACT FROM AUTHOR]

The purpose of this study was to conduct a factual survey to evaluate the type of clinical research support offered by service providers (supporters) in Japanese academic research organizations (AROs). From September to October 2018, we conducted an online questionnaire targeting researchers and supporters of AROs, including individuals supporting research and development (R&D) planning, as well as those involved in study management, biostatistics, coordination, data management, monitoring, and auditing. The number of responses was tabulated for each survey item. For items with written descriptions, we compiled summaries using the inductive regression method of qualitative research. Responses were obtained from 124 researchers, 258 supporters, and 40 AROs. None of the institutions responded that they had a performance index for all types of service providers, whereas 47% of institutions had an index for 1–3 types of service providers, and 40% of institutions had no index. Many institutions responded that they had a performance index for coordinators and data management, but few responded that there was a performance index for individuals engaged in R&D and study management. Furthermore, for all evaluations of AROs and researchers, the level of supporter satisfaction was low at only 20%. There was a discrepancy between the levels of researcher expectations and the actual contribution of R&D in the process of research planning. Our survey revealed that there is currently no performance index for services supporting clinical research. In future studies, we need to examine a performance index that accurately reflects the researcher attitudes revealed in this study. [ABSTRACT FROM AUTHOR]

When evaluating the efficacy of foods with health claims (FHC), each country sets different standards for efficacy evaluation endpoints in clinical trials, which may result in a barrier, namely the case that the claim that is allowed in Japan cannot be used on the label in another region and vice versa. We aimed to investigate the efficacy evaluation endpoints used in clinical trials of FFCs containing ID and submitted in Japan, in reference to the EU requirements for substantiating the claim, namely "reduction of post-prandial glycemic responses". We detected only one difference in efficacy evaluation endpoints, which was insulin levels. We found 67 such clinical trials cited in systematic literature reviews on finished products or functional substance(s). Of these, 43 (64%) trials lacked insulin assessment. Particularly, for foods that were claimed to reduce post-prandial glycemic responses, the EU does not consider a claim to be substantiated unless insulin levels have been evaluated. Our findings suggest the need for standardization of requirements for FHC between Japan and the EU. This consideration will strengthen the evidence for clinical significance of ID and allow products labeled with this health claim to be more widely distributed. [ABSTRACT FROM AUTHOR]

Health support pharmacies (HSPs) have been established as a new category of pharmacies in Japan. In addition to prescriptions, HSPs provide several health services, including consultations on diet/nutrition, health foods, and nursing care. Therefore, not only individuals receiving medications but also community residents should have access to HSPs. However, it is unclear whether people are aware of HSPs. Thus, the purpose of this study was to assess the awareness about HSPs and determine the need for their services. To this end, we conducted an online cross-sectional questionnaire survey in 10,000 Japanese adults. Approximately 60.2% of the participants were aware of family pharmacies/pharmacists, and 21.8% of these participants had a family pharmacy/pharmacist. Meanwhile, 2.6% of the participants were aware of HSPs, while 9.2% of the participants had only heard of HSPs. Awareness of HSPs was higher among men and younger individuals than among women and older generations. In addition, only 7.2% of the participants were aware of the location of the HSP in their area of residence. At the time at which this survey was conducted, only 3.5% of the participants were using HSP services, and half of them did not perceive the merits of using these services. However, 44.4% of the participants wished to avail themselves of HSP services in the future, and this desire increased with age. Half of the participants wished to use services that were associated with drugs, and the need for other services, such as consultations on diet/nutrition or health foods, was low. In conclusion, there was low awareness about HSPs among the survey participants. However, from our findings, we gathered that if individuals are aware of HSPs, they will wish to use HSP services. To improve healthy life expectancy, it is important to increase awareness about HSPs and their number. [ABSTRACT FROM AUTHOR]

From 2012 to 2017, many adverse events, such as irregular vaginal bleeding and menstrual disorders, associated with the use of health foods containing Pueraria mirifica were reported in PIO-NET. Health foods containing P. mirifica claim mastogenic or body shaping effects, and it is for this reason that many women use these products. As a result, the Japanese government investigated and assessed the possibility of the occurrence of adverse effects associated with the use of other ingredients in health foods and labelled P. mirifica, Coleus forskohlii, black cohosh, and greater celandine as "designated ingredient, etc."The present study showed that recognition of "designated ingredient, etc." was 45.9% and that there was a difference between consumers and healthcare professionals. The prevalence of food containing P. mirifica use was 1.2%. Almost half of users experienced adverse events, such as irregular vaginal bleeding and menstrual disorder. Some subjects had a good perception towards "designated ingredient, etc.," such as "It seems effective"(32.7%) and "It seems good for health"(18.9%). After reading the descriptive text, their positive perceptions decreased.In conclusion, the recognition of "designated ingredient, etc." is insufficient. To avoid adverse events associated with "food containing designated ingredient, etc.," detailed information should be provided.

The prevalence of health food use is increasing not only among healthy individuals but also among patients. Many patients consume drugs and health foods concomitantly, and most of them use more than one drug and one health food. In this regard, the interactions between drugs and health foods should be addressed. However, it is not clear where healthcare professionals can get sufficient information about the interactions between drugs and health foods. To address this issue, we conducted an online questionnaire about the consultation and attitude concerning and information source of interactions between drugs and health foods among pharmacists and dietitians. Only 29.7% of pharmacists and 14.0% of dietitians always confirmed the use of health foods among their patients, even though they work at pharmacies or hospitals. Regarding concomitant use, 79.2% of pharmacists and 60.2% of dietitians allowed their patients to continue concomitant use, and less than 20% of them advised their patients to avoid concomitant use. Most of them checked the manufacturer's website and could not obtain sufficient information about the interactions between drugs and health foods. However, they utilized the "Information system on safety and effectiveness for health foods (HFNet)," which is the website of the National Institutes of Biomedical Innovation, Health and Nutrition, to obtain information, if they were aware of this. In conclusion, pharmacists and dietitians need more information about the interactions between drugs and health foods, and HFNet may play an important role as information source.

The purpose of this study was to conduct a factual survey to evaluate the type of clinical research support offered by service providers (supporters) in Japanese academic research organizations (AROs). From September to October 2018, we conducted an online questionnaire targeting researchers and supporters of AROs, including individuals supporting research and development (R&D) planning, as well as those involved in study management, biostatistics, coordination, data management, monitoring, and auditing. The number of responses was tabulated for each survey item. For items with written descriptions, we compiled summaries using the inductive regression method of qualitative research. Responses were obtained from 124 researchers, 258 supporters, and 40 AROs. None of the institutions responded that they had a performance index for all types of service providers, whereas 47% of institutions had an index for 1-3 types of service providers, and 40% of institutions had no index. Many institutions responded that they had a performance index for coordinators and data management, but few responded that there was a performance index for individuals engaged in R&D and study management. Furthermore, for all evaluations of AROs and researchers, the level of supporter satisfaction was low at only 20%. There was a discrepancy between the levels of researcher expectations and the actual contribution of R&D in the process of research planning. Our survey revealed that there is currently no performance index for services supporting clinical research. In future studies, we need to examine a performance index that accurately reflects the researcher attitudes revealed in this study., (© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.)