Treatment Patterns in Newly Diagnosed Multiple Myeloma Patients in Japan Using A Large-scale Claims Database： Retrospective Cohort Study / 薬剤疫学

Objective: To describe the treatment patterns and time to next treatment (TTNT) in newly diagnosed multiple myeloma patients (MM) using a large-scale claims database in Japan.Design: Cohort studyMethods: The patients with newly diagnosed MM from 2008 to 2015 were classified into two groups: age <65 years, and age ≥65 years. Specific regimens and general regimens were identified with a complex algorithm considering interval of no therapy, additional and discontinued agents. Correspondingly, TTNT between the first- and second-line were measured among non-transplant patients with Kaplan-Meier method.Results: A total of 425 patients were eligible to participate in the analysis. The most common regimen for the treatment of MM was bortezomib-based regimens (52.9％ in the first-line, 28.2％ in later lines), followed by melphalan-prednisolone (27.1％ in the first-line, 12.9％ in later lines) and lenalidomide-based regimens (4.7％ in the first-line, 26.1％ in later lines). TTNT between the first- and second-line was 11.4 months and was seen to vary greatly with each regimen. A statistically longer TTNT was observed in subgroups of patients aged 65 years or over compared with patients aged younger than 65 years, but no statistical difference was found between conventional therapy and novel therapy.Conclusion: Based on the data from the study, patients with MM were commonly treated with novel agent-based regimens, especially bortezomib-based regimens. Between the first- and second-line therapies a relatively short TTNT was observed, indicating that therapies in clinical practice poorly complied with treatment guidelines.

Treatment Patterns in Newly Diagnosed Multiple Myeloma Patients in Japan Using A Large-scale Claims Database： Retrospective Cohort Study / 薬剤疫学

Objective: To describe the treatment patterns and time to next treatment (TTNT) in newly diagnosed multiple myeloma patients (MM) using a large-scale claims database in Japan.Design: Cohort studyMethods: The patients with newly diagnosed MM from 2008 to 2015 were classified into two groups: age <65 years, and age ≥65 years. Specific regimens and general regimens were identified with a complex algorithm considering interval of no therapy, additional and discontinued agents. Correspondingly, TTNT between the first- and second-line were measured among non-transplant patients with Kaplan-Meier method.Results: A total of 425 patients were eligible to participate in the analysis. The most common regimen for the treatment of MM was bortezomib-based regimens (52.9％ in the first-line, 28.2％ in later lines), followed by melphalan-prednisolone (27.1％ in the first-line, 12.9％ in later lines) and lenalidomide-based regimens (4.7％ in the first-line, 26.1％ in later lines). TTNT between the first- and second-line was 11.4 months and was seen to vary greatly with each regimen. A statistically longer TTNT was observed in subgroups of patients aged 65 years or over compared with patients aged younger than 65 years, but no statistical difference was found between conventional therapy and novel therapy.Conclusion: Based on the data from the study, patients with MM were commonly treated with novel agent-based regimens, especially bortezomib-based regimens. Between the first- and second-line therapies a relatively short TTNT was observed, indicating that therapies in clinical practice poorly complied with treatment guidelines.

Cost-effectiveness of molar single-implant versus fixed dental prosthesis.

BACKGROUND: This study evaluates the cost-effectiveness of implants (Implant), insurance fixed dental prosthesis (IFDP) and private fixed dental prosthesis (PFDP) for a single intermediate missing tooth in the molar region to calculate the Incremental Cost Effectiveness Ratio (ICER). METHODS: The Markov model for cost-effectiveness analysis of the Implant, IFDP and PFDP was carried over maximum 30 years. The starting age for prosthetic treatment was decided to be 50 years. The General Oral Health Assessment Index (GOHAI) was used for the indicator of effectiveness as an oral health QOL value. The GOHAI value was collected from patients who visited the Department of Oral Implantology of Osaka Dental University between September 2014 and March 2016. In addition, the Tornado diagram was drawn and Monte-Carlo simulations made for sensitivity analysis. RESULTS: From the analysis of survey of QOL of each stage and treatment, the selection of an Implant led to a higher QOL value than FDP. However, the estimated 30-year cost for IFDP was lower than Implant. It also became evident that PFDP had an extended dominated condition compared with IFDP and Implants. The ICER on the Implant versus IFDP was €1423.00. CONCLUSIONS: These results suggest that a better of QOL value can be obtained from an Implant than from IFDP or PFDP. An evaluation form using an indexed scale for oral health-related aspects needs to be developed that is also consistent as an indicator of effect.

Application of the Real World Data for Pharmacoepidemiology Reserach / 薬剤疫学

Recently, medical real world data involving claims data, drug data, and electrical medical record database have been developed worldwide and can be utilized for the phrmacoepidemiology research.The results of the pharmacoepidemiology research with these database contribute not only to post-marketing safety research but also to the outcomes research and pharmacoeconomic evaluation. On the other hand, collaborating with a number of local governments, we have developed maternal and child health check-up and school health check-up database in Japan. The development of healthcare lifecourse data like this will contribute to the preventive medicine, the understanding of the rare diseases, and drug development.

<b>Application of the Real World Data for Pharmacoepidemiology Reserach </b> / 薬剤疫学

<p>Recently, medical real world data involving claims data, drug data, and electrical medical record database have been developed worldwide and can be utilized for the phrmacoepidemiology research.The results of the pharmacoepidemiology research with these database contribute not only to post-marketing safety research but also to the outcomes research and pharmacoeconomic evaluation. On the other hand, collaborating with a number of local governments, we have developed maternal and child health check-up and school health check-up database in Japan. The development of healthcare lifecourse data like this will contribute to the preventive medicine, the understanding of the rare diseases, and drug development.</p><p></p>

A Survey of Physicians' Understanding of the Regulatory Systems for Clinical Trials in Japan / General Medicine

<b>Background:</b> Re-revision of the Ethical Guidelines for Clinical Study (EGCS) in Japan is planned in 2013. It is important to ascertain the current situation of physicians' understanding to conduct clinical trials. It seems that the difference in regulatory processes between commercial and non-commercial clinical trials has caused significant confusion for physicians in conducting clinical trials in Japan.<br>This survey was undertaken in order to improve awareness of the differences between both types of clinical trials. Furthermore, this survey examined whether it was effective to promote about clinical trials under newly introduced regulatory guidelines and to examine the subsequent willingness of physicians to conduct such clinical trials.<br><b>Methods:</b> From 24^th March to 24^th April 2009 inclusive, a questionnaire survey was conducted targeting 286 physicians working at Shiga University of Medical Science Hospital. A follow-up survey was conducted among 109 participants at a lecture about clinical trials on 8^th July 2009.<br><b>Results:</b> Physicians who had prior knowledge of the regulations, purposes, or support systems for commercial and non-commercial clinical trials responded positively that they were more likely to conduct clinical trials, while physicians who had no prior knowledge of them responded negatively. Both groups reported that their daily working pressures and cumbersome regulatory processes prevented them from conducting clinical trials.<br><b>Conclusion:</b> Japanese physicians lack knowledge and information about clinical trials, leading to negative perceptions and reduced willingness to conduct such studies. Thus, the introduction of any strict and complex regulations should be approached carefully when the environment for clinical trials has not yet been established.

Challenges in the conduct of clinical research / 医学教育

The promotion of clinical research in Japan requires the establishment of a formal and systematic education and training program for clinicians to ensure they become effective clinician investigators. The first of its kind in Japan, a formal 1-year masters-degree-level training program (MCR course) was started at Kyoto University School of Medicine and Public Health. The first 28 students graduated in 2008, with most returning to their original clinical institutions. <br>1) As follow-up, we conducted a self-administered questionnaire survey of all 28 graduates (response rate, 86%) concerning the current status of clinical research and problems encountered at their institutions.<br>2) Almost 40% of respondents (n=24) reported &quot;no time&quot; or &quot;no research collaborators&quot; for clinical research.<br>3) Twenty respondents (83%) have attempted to promote clinical research at their hospital or workplace, but only 1 has received institutional support.<br>4) Over half of the respondents (54%) would like to be working in both clinical research and clinical practice at their hospital in the future (10-year timescale). Forty-two percent of respondents had a concrete image of the clinical researcher's career path. <br>5) Although open to improvement, the MCR program presents a concrete model for the education of clinical researchers. These findings suggest that promoting the conduct of clinical research requires the implementation of a support system and adjustment of personal and physical infrastructure.

A survey of clinicians' interest in performing clinical research and in education for clinical research / 医学教育

Background: Because of a severe shortage of clinical researchers in Japan, training clinical physicians to perform clinical research is an important issue in medical education. Although education has started to provide a foundation for clinical research, it is unclear whether clinicians, who should play a central role in a clinical research, are interested in performing clinical research and participating in a training program for clinical research.1) We performed a cross-sectional Internet survey to determine the interest of clinicians' interest in performing a clinical research and participating in a clinical-research training program.2) A total of 2176 clinicians were sent emails requesting their participation in this survey, and 310 responded (response rate, 14.6%). Eighty-five percent of the respondents were interested in conducting clinical research, and 78% were willing to participate in a clinical-research training program.3) Most respondents were willing to participate in a training program as part of an educational seminar or a training course after a few years of clinical practice. The respondents desired an educational system that would allow them to learn about clinical research while continuing their clinical practice.4) Although the rate of willingness to participate in a training program was highest (90%) among respondents who wanted to earn a doctorate, the rates were also high among those who did not want to earn a doctorate (76%) and those who had already earned a doctorate (74%).5) An educational system for clinical research should allow graduate schools to play leading role in training and should be flexible enough for clinicians who do not want to earn a doctorate.