Characteristics of patients with longer treatment period of lenvatinib for unresectable hepatocellular carcinoma: A post-hoc analysis of post-marketing surveillance study in Japan. PLOS ONE. 2024; 19(3): e0298420.

-Role of CSS : medical writing (acknowledgements)
https://doi.org/10.1371/journal.pone.0298420

Association between glycemic control and patient-reported outcomes in adults with type 1 diabetes in Japan: the SAGE study subanalysis. Diabetol Int. 2023. Published first online: November 22, 2023.

-Role of CSS : medical writing (acknowledgements)
https://doi.org/10.1007/s13340-023-00668-4

Validation and comparison of the coding algorithms to identify people with migraine using Japanese claims data. Front. Neurol. 2023; 14.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.3389/fneur.2023.1231351

Impact of primary headache on daily activities from real world data in Japan. International Headache Congress Sep 14, 2023. Seoul, Korea.

Real-world treatment patterns of subsequent therapy after palbociclib in patients with advanced breast cancer in Japan. Breast. 2023 May 27;70:1-7.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.1016/j.breast.2023.05.006

Real-world treatment patterns of novel drugs in relapsed or refractory acute lymphoblastic leukemia patients in Japan. Future Oncol. Published first online: 2023 May 22.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.2217/fon-2022-1314

We collaborated with Juntendo University on a new scientific publication that addresses the challenges of generating real-world evidence (RWE) in Japan using real-world data (RWD). Key challenges discussed include transparency of RWD sources, data linkage across care settings, definition of clinical outcomes, transparency of study design, and management of biases. Our publication suggests strategies to overcome these challenges and enhance the credibility of RWE studies in Japan.

Strategies to Address Current Challenges in Real-World Evidence Generation in Japan.
Drugs - Real World Outcomes 2023; 10: 167–176.
https://doi.org/10.1007/s40801-023-00371-5

JSPAからはプレスリリースが発表されております。
https://jspa-nsc.com/pdf/230424.pdf

Exploring changes in attitudes, behaviors, and self-measured health data through lifestyle modification support by community pharmacists: Suito-Ogaki Selfcare (SOS) trial. Integr Pharm Res Pract. 2023; 12: 87-99.

-Role of CSS : Study office support, Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.2147/IPRP.S408813

Safety and effectiveness of molnupiravir (LAGEVRIO®) capsules in Japanese patients with COVID-19: interim report of post-marketing surveillance in Japan. Infect Dis Ther. Published first online: 16 March 2023.

-Role of CSS : medical writing (acknowledgements)
https://doi.org/10.1007/s40121-023-00782-5

Perioperative analgesics and anesthesia as risk factors for postoperative chronic opioid use in patients undergoing total knee arthroplasty: a retrospective cohort study using Japanese hospital claims data. Drugs - Real World Outcomes. Published first online: 28 March 2023.

-Role of CSS : Planning, Statistical analysis, medical writing (author, acknowledgements)
https://doi.org/10.1007/s40801-023-00363-5

Impact of tolvaptan add-on treatment on patients with heart failure requiring long-term congestion management: A retrospective cohort study using a medical claim database in Japan. Journal of Cardiology. Published first online: 11 April 2023.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.1016/j.jjcc.2022.12.006

We collaborated with Juntendo University on a new scientific publication that evaluated claims-based algorithms for detecting patients with colorectal cancer using administrative claims data in a Japanese hospital. The results showed that the diagnosis code-based algorithm had a high positive predictive value (PPV) of 86.3%, which increased to 94.0% when the diagnosis codes were restricted to site-specific cancer codes, and was sufficient and valid for identifying colorectal cancer.

Validation of algorithms to identify colorectal cancer patients from administrative claims data of a Japanese hospital. BMC Health Serv Res. Published first online: 21 March 2023.
https://doi.org/10.1186/s12913-023-09266-1

Linguistic and Psychometric Validation of the Cognition Bolt-On Version of the Japanese EQ-5D-5L for the Elderly. J Alzheimers Dis. 2023;91(4):1447-1458.

-Role of CSS : Planning, Implementation, Statistical analysis, medical writing (author, acknowledgements)
https://doi.org/10.3233/JAD-221080

Clinical characteristics, medication use, and impact of primary headache on daily activitieis: an observational study using linked online survey and medical claims data in Japan. BMC Neurology. Published first online: 21 February 2023.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.1186/s12883-023-03122-9

We collaborated with Juntendo University on a new scientific publication that attempted to replicate the three published randomized controlled trials (RCTs) using a Japanese claims and health checkup database. Comparing the results of RCTs with those of real-world data (RWD) studies mimicking the critical study elements of RCTs, reasons for the discrepancy and elements to be considered in RWD studies were discussed.

An attempt to replicate randomized trials of diabetes treatments using a Japanese administrative claims and health checkup database: A feasibility study.
Drugs - Real World Outcomes. Published first online: 1 February 2023.
https://doi.org/10.1007/s40801-023-00353-7

We collaborated with Juntendo University on a new scientific publication that evaluated claims-based algorithms for detecting patients with bone metastases, using administrative claims data in a Japanese hospital. The results showed that the diagnosis code-based algorithm had a high positive predictive value (PPV) of approximately 85%, and was sufficient and valid for identifying bone metastases.

Validation of algorithms to identify bone metastases using administrative claims data in a Japanese hospital.
Drugs - Real World Outcomes. Published first online: 18 January 2023.
https://doi.org/10.1007/s40801-022-00347-x

Safety and effectiveness of lenvatinib in patients with unresectable hepatocellular carcinoma in real-world clinical practice: an observational post-marketing study in Japan. Drugs - Real World Outcomes. Published first online: 5 January 2023.

-Role of CSS : medical writing (acknowledgements)
https://doi.org/10.1007/s40801-022-00348-w

We collaborated with Juntendo University on a new scientific publication which compared the effect estimates among different time-zero settings in a comparative effectiveness study with a non-user comparator using real-world data. The results showed that the treatment effect varied depending on how to set time zero, highlighting the significant impacts of time-zero settings on the study results.

Impact of "time zero" of follow-up settings in a comparative effectiveness study using real-world data with a non-user comparator: comparison of six different settings.
Drugs - Real World Outcomes. Published first online: 28 November 2022.
https://doi.org/10.1007/s40801-022-00343-1

Use of RWD to Support Healthcare Decision Making in Japan. The Devil Lies in the "D". How Is the Data Landscape Evolving in Japan?
ISPOR Europe 2022. Nov 2022, Vienna, Austria.

Linguistic and Psychometric Validation of the “Cognition” Bolt-on Version of the Japanese EQ-5D-5L (EQ-5D-5L+C) by Adding a Cognitive Dimension for the Elderly. ISPOR Europe 2022. Nov 2022, Vienna, Austria.

Effect of Parenteral Energy or Amino Acid Doses on In-Hospital Mortality Among Patients With Aspiration Pneumonia: A Cohort Medical Claims Database Study. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1683-1690.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.1093/gerona/glab306

Physician consultation rates and characteristics among workers with chronic pain or headache who participated in a behavioural change program: a retrospective database analysis using real-world healthcare data. BMJ Open. 2022 Nov 10;12(11):e056846.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.1136/bmjopen-2021-056846

このたび、2022年11月1日付で磯村達也は代表取締役社長兼ＣＥＯを退任し、創業者取締役兼ＣＶＯ(Chief Visionary Officer) に就任いたしました。
また、共同創業者である菊池徳昌が代表取締役社長兼ＣＥＯに就任いたしました。

Reduction in asthma exacerbation rate after mepolizumab treatment initiation in patients with severe asthma: A real-world database study in Japan. Pulm Pharmacol Ther. 2022; 75: 102130.

-Role of CSS : medical writing (acknowledgements)
https://doi.org/10.1016/j.pupt.2022.102130

Treatment discontinuation among patients with schizophrenia treated with brexpiprazole and other oral atypical antipsychotics in Japan: A retrospective observational study. Adv Ther. 2022 Sep;39(9):4299-4314.

-Role of CSS : Statistical analysis, medical writing (acknowledgements)
https://doi.org/10.1007/s12325-022-02252-9

A study to investigate the prevalence of headache disorders and migraine among people registered in a health insurance association in Japan. J Headache Pain. 2022; 23(1): 70.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1186/s10194-022-01439-3

The use of a network analysis to identify associations and temporal patterns among non-communicable diseases in Japan based on a large medical claims database. Drugs - Real World Outcomes. Published first online. 2 Jul 2022.

-Role of CSS : Statistical analysis, medical writing (authors, funding)
https://doi.org/10.1007/s40801-022-00310-w

Association between HbA1c levels and diabetic peripheral neuropathy: A case–control study of patients with type 2 diabetes using claims data. Drugs - Real World Outcomes. Published first online. 20 June 2022.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1007/s40801-022-00309-3

興和株式会社は多世代居住型健康スマートタウン「Suitaサスティナブル・スマートタウン」（所在地：大阪府吹田市）に入居する住民の皆様に対し、“人生100年時代”を見据えた健康増進サポートサービス「Suitaセルフケア・スイート・トライアル」の提供を2022年５月18日より開始するというプレスリリースを発表いたしました。
当社は、興和株式会社と共同で、2020年4月よりセルフケアに関する様々な健康情報を一括して管理するためのデータプラットフォームの開発に取り組んでおり、同サービスにも協力企業として参画してまいります。

詳細はこちら

In Japan, there is growing interest in Real-World Evidence to support hypothesis generation and decision-making to enable improved clinical research. We collaborated with Evidera and Juntendo University on a new scientific publication which highlights uses of two real-world databases, MDV and JMDC, highly used in Japan among the pharmaceutical industry.

Context and Considerations for Use of Two Japanese Real-World Databases in Japan: Medical Data Vision and Japanese Medical Data Center. Drugs - Real World Outcomes (2022). Published first online: 18 March 2022
https://doi.org/10.1007/s40801-022-00296-5

Internet survey on factors associated with care-seeking behaviours of people with chronic musculoskeletal pain in Japan. J Orthop Surg (Hong Kong). 2021 Sep-Dec;29(3):23094990211044836.

-Role of CSS : Statistical analysis, medical writing (funding)
https://doi.org/10.1177/23094990211044836

健常成人を対象としたEDC，ePRO，およびウェアラブルデバイスを用いた共同調査結果とその有用性．Progress in Medicine. 2022，第42巻，第1号，p. 91-100

-Role of CSS : medical writing (acknowledgments)

Real-world treatment patterns of palbociclib and blood count monitoring in patients with advanced breast cancer in Japan. Future Oncology. Published first online. 21 Mar 2022.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.2217/fon-2021-1448

Comparative analysis of medical costs after hepatectomy versus radiofrequency ablation in patients with hepatocellular carcinoma in real-world clinical practice. Hepatol Res. Published first online. 10 Feb 2022.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1111/hepr.13756

Pharmacotherapy for low back pain and sciatica: A narrative review. J Spine Res. 2022; 13(2): 67-86.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.34371/jspineres.2021-0055

A post marketing survey of intravenous daptomycin in Japanese patients. J. New Rem. & Clin. 2021; 70: 1189-1215.

-Role of CSS : medical writing (acknowledgments)

Nutritional management in inpatients with aspiration pneumonia: a cohort medical claims database study. Arch Gerontol Geriatr. 2021; 95: 104398.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1016/j.archger.2021.104398

Treatment patterns and medical costs after hepatectomy in real-world practice for patients with hepatocellular carcinoma in Japan. Hepatol Res. Published first online. 2021 Jul 19.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1111/hepr.13701

Real-world treatment patterns of patients with atopic dermatitis in Japan: Analysis of the JMDC Claims Database. J Cutan Immunol Allergy. 2021 First published: 21 May 2021

-Role of CSS : Statistical analysis (acknowledgments) 
https://doi.org/10.1002/cia2.12180

Understanding confidence in the human papillomavirus vaccine in Japan: a web-based survey of mothers, female adolescents, and healthcare professionals. Hum Vaccin Immunother. 2021. Published first online 01 Jun 2021.

-Role of CSS : Protocol writing, Statistical analysis, CSR writing (acknowledgments) 
https://doi.org/10.1080/21645515.2021.1918042

Real-world Evidence Generation in Japan: Uses and Challenges, Virtual ISPOR 2021, 2021 May

Real-world_Evidence_Generation_in_Japan_Poster_ISPOR2021.pdf

What You Need to Know About Real-World Databases in Japan, The Evidence Forum, 2021, 2021 May, US

-Article: https://www.evidera.com/white-paper-what-you-need-to-know-about-real-world-databases-in-japan/
-The Evidence Forum – 2021 Spring Issue:https://www.evidera.com/wp-content/uploads/2021/05/TheEvidenceForum-2021-SpringIssue.pdf

Glycemic control status, diabetes management patterns, and clinical characteristics of adults with type 1 diabetes in Japan: Study of Adults’ Glycemia in T1DM subanalysis. Diabetol Int (2021). Published first online: 25 April 2021

-Role of CSS : medical writing (acknowledgments) 
https://doi.org/10.1007/s13340-021-00504-7

Multiple comorbidities increase the risk of death from invasive pneumococcal disease under the age of 65 years. J Infect Chemother. Published first online. 2021 May 4.
ISSN 1341-321X,

-Role of CSS : Statistical analysis (acknowledgments) 
https://doi.org/10.1016/j.jiac.2021.04.018

Real-world hospital mortality of liver cirrhosis inpatients in Japan: a large-scale cohort study using a medical claims database: Prognosis of liver cirrhosis. Hepatol Res. Published first online. 2021 March 12.

-Role of CSS : medical writing (acknowledgments) 
https://doi.org/10.1111/hepr.13635

Real-World Treatment Patterns and Adherence to Oral Medication Among Patients with Bipolar Disorders: A Retrospective, Observational Study Using a Healthcare Claims Database. Neuropsychiatr Dis Treat. 2021 Mar 18;17:821-833. PMCID: PMC7987324.

-Role of CSS : medical writing (acknowledgments) 
https://doi.org/10.2147/NDT.S299005

Antidyslipidemic drug prescriptions and lipid control status after unfavorable annual health checkup results: a retrospective cohort study using a health insurance database. Drugs - Real World Outcomes. Published first online. 2021 March 9.

-Role of CSS : medical writing (acknowledgments) 
https://doi.org/10.1007/s40801-021-00231-0

Effectiveness of pregabalin treatment for meuropathic pain in patients with spine diseases: a pooled analysis of two multicenter observational studies in Japan. J Pain Res. 2021;14:757-771.

-Role of CSS : medical writing (acknowledgments) 
https://doi.org/10.2147/JPR.S293556

Indices of peripheral leukocytes predict longer overall survival in breast cancer patients on eribulin in Japan. Breast Cancer. Published first online. 2021 Mar 7.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1007/s12282-021-01232-1

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database. Clinicoecon Outcomes Res. 2021;13:145-153

-Role of CSS : Statistical analysis (authors)
https://doi.org/10.2147/CEOR.S293698

Relationship of annual health checkups with the subject’s subsequent behavior of cardiovascular risk management in a real-world setting in Japan: a retrospective cohort study on changes in antihypertensive drug prescription and blood pressure from 2015 to 2017. Drugs Real World Outcomes. 2021 Jan 15. Epub ahead of print.

-Role of CSS : medical writing (acknowledgments) 
https://doi.org/10.1007/s40801-020-00224-5

Risk of hypoglycemia in Japanese people with type 2 diabetes mellitus who initiated or switched to insulin glargine 300 U/mL: A subgroup analysis of 12-month post-marketing surveillance study (X-STAR study), Diabetes Research and Clinical Practice. Published first online. 2020 Dec 24.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1016/j.diabres.2020.108647

Clinical Impact of Prescribed Doses of Nutrients for Patients Exclusively Receiving Parenteral Nutrition in Japanese Hospitals: A Retrospective Cohort Study. J Parenter Enteral Nutr. Published first online. 2020 Oct 21.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1002/jpen.2033

1. Effectiveness and safety of insulin glargine 300 unit/mL in Japanese type 2 diabetes mellitus patients: a 12-month post-marketing surveillance study (X-STAR study). Expert Opin Pharmacother. Published first online. 2020 Jul 22.
   -Role of CSS : Statistical analysis, medical writing (acknowledgments)
   https://doi.org/10.1080/14656566.2020.1785430
2. Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study). Expert Opin Pharmacother. Published first online. 2020 Aug 25.
   -Role of CSS : Statistical analysis, medical writing (acknowledgments)
   https://doi.org/10.1080/14656566.2020.1810665

Comparison of hospital length of stay of acute ischemic stroke patients with non-valvular atrial fibrillation started on rivaroxaban or warfarin treatment during hospitalization. J Med Econ. Published first online. 2020 Sep 16.

-Role of CSS : Statistical analysis, medical writing (authors, acknowledgments) 
https://doi.org/10.1080/13696998.2020.1824384

Treatment and Healthcare Cost Among Patients with Hip or Knee Osteoarthritis: A Cross-sectional Study Using a Real-world Claims Database in Japan Between 2013 and 2019. Clin Drug Investig. 2020 Sep 23. Epub ahead of print.

-Role of CSS : Statistical analysis, medical writing (authors, acknowledgments)
https://doi.org/10.1007/s40261-020-00968-6

Safety and Effectiveness of Lenvatinib in 594 Patients with Unresectable Thyroid Cancer in an All-Case Post-Marketing Observational Study in Japan. Adv Ther. 2020 Epub ahead of print.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1007/s12325-020-01433-8

A survey on total parenteral nutrition in 55,000 hospitalized patients: Retrospective cohort study using a medical claims database. Clinical Nutrition ESPEN. 2020 Epub ahead of print.

-Role of CSS : Statistical analysis, medical writing (authors, acknowledgments)
https://doi.org/10.1016/j.clnesp.2020.06.013

Psychometric properties of the Japanese version of the Kansas City Cardiomyopathy Questionnaire in Japanese patients with chronic heart failure. Health Qual Life Outcomes. 2020; 18: 236.

-Role of CSS : Statistical analysis, medical writing (authors)
https://doi.org/10.1186/s12955-020-01483-0

弊社が論文化を支援した「Breast Cancer」に掲載の原著論文「Chemotherapy-induced peripheral neuropathy in breast cancer patients treated with eribulin: interim data from a post-marketing observational study」が、"Best of Breast Cancer 2019" に選出されました。

https://www.springer.com/journal/12282/updates/17191688

肝硬変入院患者の腹水合併および治療の実態調査：診療データベースを用いたコホート研究, 肝臓, 2020, 61 巻, 6 号, p. 314-325

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.2957/kanzo.61.314

Treatment persistence between long-acting injectable versus orally administered aripiprazole among patients with schizophrenia in a real-world clinical setting in Japan. Adv Ther. Published first online. June 4, 2020.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1007/s12325-020-01396-w

順天堂大学に「リアルワールドエビデンス評価研究講座」を開設
～産学連携によるリアルワールドエビデンス研究・教育拠点の構築を目指す～

詳細はこちら

Patterns of drug treatment in patients with osteoarthritis and chronic low back pain in Japan: a retrospective database study. J Pain Res. 2019; 12: 1631-1648.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.2147/JPR.S203553

2020年2月6日に開催された、大分統計談話会「特別セッション1：リアルワールドデータ活用の最新動向」にて当社が講演しました。
開催プログラム：http://www.jp-css.com/danwa/p_61.html

2020年1月20日に開催された、日本薬剤疫学会「実務者のためのデータベース研究講座　その3」にて当社が講演しました。
開催案内：http://www.jspe.jp/committee/pdf/dbkouza03.pdf
講演スライド：http://www.jspe.jp/committee/020/0210/post_29.html

Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting. Invest New Drugs. Published first online. January 16, 2020.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1007/s10637-019-00890-5

Safety and Efficacy of Long-Term Treatment with Perampanel in Japanese Patients with Partial-Onset Seizure or Primary Generalized Tonic-Clonic Seizure in a Real-World Setting. American Epilepsy Society Annual Meeting 2019. Dec 2019, Baltimore, US.

-Role of CSS: medical writing (acknowledgments)

皮膚外用剤の物性の違いが塗布量に与える影響に関する臨床研究：成人被験者を対象としたアンケート調査による基剤の使用感と塗布量の探索的検討. Yakuzaku Zasshi 139,1313-1325(2019)

-Role of CSS : Statistical analysis (acknowledgments)

Daily practice and prognostic factors for pneumonia caused by methicillin-resistant Staphylococcus aureus in Japan: A multicenter prospective observational cohort study. J Infect Chemother. 2019 Sep 28

-Role of CSS : Statistical analysis (acknowledgments)
https://doi.org/10.1016/j.jiac.2019.08.018

A cost-effectiveness analysis of pregabalin for the treatment of patients with chronic cervical pain with a neuropathic component in Japan. J Pain Res. 2019; 12: 2785–2797.

-Role of CSS : medical writing (authors)
https://doi.org/10.2147/JPR.S203712

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A subanalysis of a post-marketing study (J-STEP/EL Study). J Diabetes Investig. Pulished first online Aug 7, 2019.

-Role of CSS : medical writing (acknowledgments)
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13125

Evidera, Inc.（本社：メリーランド州ベセスダ）と、リアルワールドリサーチに関し、日本における独占的なパートナーシップ契約を締結しました。

詳細はこちら

日本語版Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-J) およびその短縮版の開発：言語的妥当性を担保した翻訳版の作成．日本運動器疼痛学会誌．2019; 11: 35-48.

-Role of CSS : Production of translated questionnaire, linguistic validation (authors)

Sustained reduction in rotavirus-coded hospitalizations in children aged <5 years after introduction of self-financed rotavirus vaccines in Japan. Hum Vaccin Immunother. Pulished first online Aug 1, 2019.

-Role of CSS : Statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1080/21645515.2019.1638204

Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world practice: Results of 12-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT). J Diabetes Investig. Pulished first online Jun 14, 2019.

-Role of CSS : medical writing (acknowledgments)
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13097

インスリン未治療 2 型糖尿病患者におけるインスリングラルギン 300U/mL 入院導入の有効性と安全性の検討：X-STAR study サブ解析．第62回日本糖尿病学会年次学術集会．2019年5月

-Role of CSS : medical writing

Switch rates, time-to-switch, and switch patterns of antiretroviral therapy in people living with human immunodeficiency virus in Japan, in a hospital-claim database. BMC Infect Dis. 2019; 19(1): 505.

-Role of CSS : planning, statistical analysis (database analysis), medical writing (acknowledgements)
https://doi.org/10.1186/s12879-019-4129-6

Pharmacotherapy decision-making among patients with breast cancer in Japan: results of an online survey. Breast Cancer. 2019 Jun 8. Pulished first online 08 June 2019.

-Role of CSS : medical writing (acknowledgments)
https://link.springer.com/article/10.1007/s12282-019-00986-z

Dual antiplatelet therapy using cilostazol for secondary prevention in patients with high-risk ischaemic stroke in Japan: a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2019, 18(6), 539-548.

-Role of CSS : CSPS.com Trial Investigator
https://doi.org/10.1016/S1474-4422(19)30148-6

Assessment of municipalities' sociodemographic characteristics and efforts associated with the high specific medical checkup rates. Kosei no Shihyo (Journal of Health and Welfare Statistics). 2018 April; 66(4).

-Role of CSS : planning, statistical analysis, medical writing (acknowledgments)

Use of a healthcare claims database for post-marketing safety assessments of eribulin in Japan: a comparative assessment with a prospective post-marketing surveillance study. Drugs - Real World Outcomes. 2019; 6(1): 27-35.

-Role of CSS : statistical analysis (database analysis), medical writing (authors)
https://doi.org/10.1007/s40801-019-0150-8

Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled study. J Neurol Neurosurg Psychiatry. Pulished first online Jan 13, 2019.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1136/jnnp-2018-319294

Secular trend in the incidence of Japanese employees with thyroid cancer undergoing thyroidectomy from 2005 to 2014: a retrospective descriptive study using an employment-based insurance claims database. J of thyroid cancer. 2019; 1: 5-15.

-Role of CSS : medical writing
https://doi.org/10.14302/issn.2574-4496.jtc-18-2473

Differences in the incidence of postoperative pneumonia after percutaneous endoscopic gastrostomy between liquid and semi-solid nutrient administration. Eur J Clin Nutr. Published first online Jan 4, 2019.

-Role of CSS : data monitoring, statistical analysis, medical writing (acknowledgments and text [methods])
https://doi.org/10.1038/s41430-018-0380-y

Assessment of risk factors for non-specific chronic disabling low back pain in Japanese workers—findings from the CUPID (Cultural and Psychosocial Influences on Disability) study. Industrial Health. Published first online Oct 19, 2018.

-Role of CSS : statistical analysis, medical writing (authors)
https://doi.org/10.2486/indhealth.2018-0157

Greater burden of chronic comorbidities and co-medications among people living with HIV versus people without HIV in Japan: A hospital claims database study. J Infect Chemother. Published first online Nov 2, 2018.

-Role of CSS : statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1016/j.jiac.2018.10.006

Eribulin as first- or second-line chemotherapy for advanced or metastatic HER2-negative breast cancer: a real-world prospective study. The European Society for Medical Oncology 2018 Congress. Oct 2018, Munich, Germany.

-Role of CSS : medical writing

Chemotherapy-induced peripheral neuropathy in breast cancer patients treated with eribulin: interim data from a post-marketing observational study. Breast Cancer. Published first online Oct 15, 2018.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1007/s12282-018-0919-8

The Usability of Commercial Healthcare Claims Data in Japanese Pharmacovigilance: A Comparison with a Prospective Postmarketing Study. 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Aug 2018. Prague, Czech republic.

-Role of CSS : medical writing

Healthcare burden of recurrent Clostridioides difficile infection in Japan: A retrospective database study. J Infect Chemother. Published first online Sep 2018.

-Role of CSS : statistical analysis, medical writing [editorial assistance] (authors)
https://doi.org/10.1016/j.jiac.2018.07.020

[東京事務所]
〒160-0023 東京都新宿区西新宿1-20-3 西新宿高木ビル8F

Recent Trends in the Practice of Procedural Sedation Under Local Anesthesia for Catheter Ablation, Gastrointestinal Endoscopy, and Endoscopic Surgery in Japan: A Retrospective Database Study in Clinical Practice from 2012 to 2015. Drugs Real World Outcomes. Published first online Jun 18, 2018.

-Role of CSS : statistical analysis, medical writing [editorial assistance] (authors)
https://doi.org/10.1007/s40801-018-0136-y

Low-Density Lipoprotein Cholesterol Goal Attainment Rates by Initial Statin Monotherapy Among Patients With Dyslipidemia and High Cardiovascular Risk in Japan - A Retrospective Database Analysis. Circ J. 2018;82(6):1605-1613.

-Role of CSS : statistical analysis, medical writing [editorial assistance] (acknowledgments)
https://doi.org/10.1253/circj.CJ-17-0971

Comorbidities and the use of comedications in people living with HIV on antiretroviral therapy in Japan: a cross-sectional study using a hospital claims database. BMJ Open. 2018; 8(6): e019985.

-Role of CSS : statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1136/bmjopen-2017-019985

アルツハイマー型認知症に対するドネペジル塩酸塩によるADAS-J cogを用いた調査―アリセプト^®特定使用成績調査最終報告とADAS-J cog合計得点推移モデルの構築―. 老年精神医学雑誌. 2018; 29(4): 413-426.

-Role of CSS : modeling in statistical analysis (methods)

Comorbidities and co-medications in populations with and without chronic hepatitis C virus infection in Japan between 2015 and 2016. BMC Infect Dis. 2018; 18(1): 237.

-Role of CSS : statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1186/s12879-018-3148-z

Pregabalin as an analgesic option for patients undergoing thoracotomy: cost analysis of pregabalin versus epidural analgesia for post-thoracotomy pain relief. J Thorac Dis. 2018; 10(4): 2321-2330.

-Role of CSS : statistical analysis, medical writing (authors)
https://doi.org/10.21037/jtd.2018.03.109

Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation. BMC Musculoskelet Disord. 2018;19(1):71.

-Role of CSS : planning, statistical analysis, medical writing (authors)
https://doi.org/10.1186/s12891-018-1986-x

Decline of rotavirus-coded hospitalizations in children under 5 years: A report from Japan where rotavirus vaccines are self-financed. Vaccine. Published first online on Dec 11, 2017.

-Role of CSS : statistical analysis, medical writing (acknowledgments)
https://www.ncbi.nlm.nih.gov/pubmed/29241644

Long-term safety and efficacy of tofogliflozin as add-on to insulin in patients with type 2 diabetes: Results from a 52-week, multicentre, randomized, double-blind, open-label extension, Phase 4 study in Japan (J-STEP/INS). Diabetes Obes Metab. Published first online on Feb 11, 2018.

-Role of CSS : medical writing (acknowledgments)
https://doi.org/10.1111/dom.13213

新日本科学グループ内の連携強化及び業務効率化の一環として、2018年1月1日付で、当社のSMO事業を株式会社新日本科学ＳＭＯに譲渡いたしました。

これまで弊社は、SMO事業としては名古屋地域限定でがん領域に強みを持った支援を展開してまいりました。今後、グループ内での連携を強化することにより、名古屋地域における治験施設の拡充とがん領域サポートの強化をすることが可能となり、これまで以上に顧客ニーズへ対応してまいります。また、リアルワールドリサーチや費用対効果分析などを中心としたクリニカルリサーチ事業とインテグレイティッドヘルスケア事業に集中させ、信頼できる医療情報の創出と提供を今後更に推進してまいります。

A real-world observational study of eribulin in patients with soft-tissue sarcoma in Japan. The Connective Tissue Oncology Society 2017 Annual Meeting. Nov 2017, Hawaii, US.

-Role of CSS : medical writing

Clinical and economic burdens experienced by patients with painful diabetic peripheral neuropathy: An observational study using a Japanese claims database. PLoS One. 2017; 12(10): e0187250.

-Role of CSS : statistical analysis, medical writing (authors)
https://doi.org/10.1371/journal.pone.0187250

Prospective observational study of peripheral neuropathy in breast cancer patients treated with eribulin. ESMO 2017 Congress. Sep 2017, Madrid, Spain.

-Role of CSS : medical writing

Assessment of potential risk factors for new onset disabling low back pain in Japanese workers: findings from the CUPID (cultural and psychosocial influences on disability) study. BMC Musculoskelet Disord. 2017; 18(1): 334.

-Role of CSS : data collection, statistical analysis, medical writing (authors)
https://doi.org/10.1186/s12891-017-1686-y

「第17回 CRCと臨床試験のあり方を考える会議」(2017年9月2日～3日)において、当社CRCがポスター発表しました。
・CRCの同意補助説明を考える（ポスター）．9月2日

Diagnostic capability of "Spine paindetect" to screen for neuropathic pain caused by spinal disorders. The 44th Annual Meeting of the International Society for the Study of the Lumbar Spine. Jun 2017, Athens, Greece.

-Role of CSS : planning, implementation, data collection, statistical analysis

Dipeptidyl peptidase-4 inhibitors as preferable oral hypoglycemic agents in terms of treatment satisfaction: Results from a multicenter, 12-week, open label, randomized controlled study in Japan (PREFERENCE 4 study). J Diabetes Investig. Published first online on May 2, 2017.

-Role of CSS : statistical analysis, medical writing (acknowledgments)
https://doi.org/10.1111/jdi.12659

Semi-quantitative Assessment of Tumor Spread Through Air Spaces (STAS) in Early Stage Lung Adenocarcinomas. J Thorac Oncol. Published first online on Mar 28, 2017.

-Role of CSS : statistical analysis (acknowledgments and text [methods])
https://doi.org/10.1016/j.jtho.2017.03.019

1. The influence of personality and perceived stress on the development of breast cancer: 20-year follow-up of 29,098 Japanese women. Sci Rep, 2016; 2(6): 32559.
   https://doi.org/10.1038/srep32559
2. Perceived Stress and Colorectal Cancer Incidence: The Japan Collaborative Cohort Study. Sci Rep, 2017; 16(7): 40363.
   https://doi.org/10.1038/srep40363

Estimated risk for chronic pain determined using the generic STarT Back 5-item screening tool. J Pain Res, 2017; 24(10): 461-467.
https://doi.org/10.2147/JPR.S129585

質問票「Somatic Symptom Scale-8 (SSS-8)」の原作者であるBenjamin Gierk氏が、Wikipediaにて日本語版SSS-8および関連文献を掲載しました。
https://en.wikipedia.org/wiki/Somatic_Symptom_Scale_-_8

本質問票の日本語版の開発において、当社は下記の業務を支援いたしました。

• 日本語版Somatic Symptom Scale-8(SSS-8[身体症状スケール])の開発－言語的妥当性を担保した翻訳版の作成－. 心身医学, 2016;Vol.56 No.9, 2016: 931-937.
  -Role of CSS : planning, implementation, data collection, statistical analysis, medical writing
  
• Development of a Japanese version of the Somatic Symptom Scale-8: Psychometric validity and internal consistency. General Hospital Psychiatry. 2017;45:7-11.
  -Role of CSS : planning, statistical analysis, medical writing
  

Development of a Japanese version of the Somatic Symptom Scale-8: Psychometric validity and internal consistency. General Hospital Psychiatry. 2017;45:7-11.

-Role of CSS : planning, statistical analysis, medical writing (authors)
https://doi.org/10.1016/j.genhosppsych.2016.12.002

株式会社新日本科学のグループ会社である株式会社CLINICAL STUDY SUPPORT（本社： 愛知県名古屋市、代表取締役社長：磯村 達也、以下「CSS社」）と株式会社カンター・ジャパン（日本法人：東京都渋谷区、代表取締役社長兼CEO：大竹 秀彦、以下「カンター社」）は、製造販売後の使用実態下における「リアルワールドリサーチ（以下RWR）」の分野において業務提携いたしましたので、お知らせいたします。今後大きな成長の見込まれるRWRにおいて、パブリケーションを見据えたユニークなリサーチ力を持つCSS社とグローバルなマーケティング力を持つカンター社が協働で取り組むことで、日本という有望市場を基盤にグローバルに向けた業容拡大を図ってまいります。

RWRは製造販売後の使用実態下における薬の有用性やプロファイリングなど、開発段階では得られないエビデンスを創出し、ライフサイクルマネジメントを強化する重要な役割を担うことが期待されています。いち早くその重要性に注目した欧米では、使用実態下のリアルワールドデータ（以下RWD）の集積及びそれらを活用したエビデンスの創出が進められており、実際にライフサイクルマネジメントの強化に繋がっています。日本は米国、中国に続く世界有数の医薬品市場規模を誇り、新薬の使用実績データが世界で最も多く迅速に収集可能であることから、RWDに基づくエビデンスを創出するリーディングカントリーとしての多大なる可能性を秘めています。

CSS社は2004年の起業以来、RWRに注目し、デザイン、統計解析、メディカルライティングなど、この分野での数多くの支援実績を構築してまいりました。一方、カンター社は傘下にカンターヘルスを持ち、世界40カ国以上のヘルスケアデータビジネスに関わる中で世界的なリアルワールドエビデンスの潮流に着目し、各国で実績構築に取り組んでいます。

今後は、両社それぞれの強みを活かした協働により、貴重なリアルワールドエビデンスをパブリケーションのみで終わらせず、臨床現場での実践に繋がるマーケティング、さらには市場での価値を最大化するブランディングを日本から世界に向けて展開するため、クライアントへの共同提案、共同プロモーション及び共同販売を積極的に行ってまいります。また、医薬品開発の受託研究機関でCSS社の親会社でもある株式会社新日本科学とも連携し、日本の医薬品業界に加え欧米市場への事業展開も視野に入れた、日本並びに世界の医療へ貢献するビジネスの展開を目指します。

※プレスリリース全文（PDF)はこちら

株式会社CLINICAL STUDY SUPPORT
広報 /　田内、津田　TEL：052-211-2011　E-mail：mail@jp-css.com

Development of the Japanese Version of the Leeds Assessment of the Neuropathic Symptoms and Signs Pain Scale: Diagnostic Utility in a Clinical Setting. Pain Pract. Published first online on Oct. 22, 2016.

-Role of CSS : planning, implementation, data collection, statistical analysis, medical writing (authors)
https://doi.org/10.1111/papr.12528

The Japanese version of the STarT Back Tool predicts 6-month clinical outcomes of low back pain. J Orthop Sci. Published first online on Dec. 23, 2016.

-Role of CSS : medical writing (authors)
https://doi.org/10.1016/j.jos.2016.11.023

「第16回 CRCと臨床試験のあり方を考える会議」(2016年9月18日～19日)において、
当社CRCがポスター発表しました。
・治験業務で使用する電子システムの問題点（ポスター）．9月19日

日本語版Somatic Symptom Scale-8(SSS-8[身体症状スケール])の開発－言語的妥当性を担保した翻訳版の作成－. 心身医学, 2016;Vol.56 No.9, 2016: 931-937.

-Role of CSS : production of translated questionnaire, linguistic validation, medical writing (authors)
http://www.shinshin-igaku.com/intro/jpm.html

Psychometric Assessment of the Japanese Version of the Zurich Claudication Questionnaire (ZCQ): Reliability and Validity. PLoS ONE. 2016; 11(7): e0160183.

-Role of CSS : planning, implementation, data collection, statistical analysis, medical writing (authors)
https://doi.org/10.1371/journal.pone.0160183

腰痛予防のエクササイズ―労働者に対する私の方法―
MB Med Reha. 2016; No.198: 63-69.

-Role of CSS : statistical analysis (authors)
http://www.zenniti.com/f/b/show/b01/840/zc01/3.html

Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials. EJCN. Published first online on May 18, 2016.

-Role of CSS : planning, statistical analysis, medical writing (authors)
https://doi.org/10.1038/ejcn.2016.78

Psychometric Properties of the Japanese Version of the STarT Back Tool in Patients with Low Back Pain. PLoS ONE. 2016 Mar 22;11(3):e0152019.

-Role of CSS : planning, implementation, data collection, statistical analysis, medical writing (authors)
https://doi.org/10.1371/journal.pone.0152019

2015年12月11日に、名古屋医工連携インキュベータ （NALIC）設立10周年記念の「入居企業＆卒業企業 事業成果発表会」が開催されました。
NALICは、弊社が2006年5月から2015年5月まで入居していた、ベンチャー企業・中小企業のビジネスを支援する独立行政法人 中小企業基盤整備機構 中部本部の施設です。
本発表会では、卒業企業として、「CSSの沿革とNALIC」「今後の事業展開」等について、代表の磯村が発表しました。

名古屋医工連携インキュベータ （NALIC）
http://www.smrj.go.jp/incubation/nalic/

日本語版Menorrhagia Multi-Attribute Scale（MMAS）の開発：言語的妥当性の検討．
82（11）：P1299-1305，産科と婦人科，2015．

-Role of CSS :copyright agreement, forward translation, back translation, pilot test, medical writing (authors)
http://www.shindan.co.jp/books/index.php?menu=01&cd=3151100&kbn=2#toku

Disease state changes and safety of long-term donepezil hydrochloride administration in patients with Alzheimer's disease: interim results from the long-term, large-scale J-GOLD study in Japan. Psychogeriatrics. 2015 Jun 26. [Epub ahead of print]

-Role of CSS : statistical analysis (authors and text [methods])
https://doi.org/10.1111/psyg.12130

CRCからみた疼痛薬治験の実施ポイント． 痛みのメカニズムとこれからの治療薬・治療法の開発～治療へのニーズ・非臨床試験の適切な実施・エビデンスの得られる臨床試験デザイン～．P145-156, 技術情報協会, 2015.

http://www.gijutu.co.jp/doc/b_1827.htm