<2021>

Clinical trial risk in leukemia: Biomarkers and trial design.　Hematological Oncology 2021 Feb;　39(1):105-113.

Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication from Public Assessment Reports?   Clinical Therapeutics 2021;43(5)：888-905.

Individual Differences in Response to Antidepressants: A Meta-analysis of Placebo-Controlled Randomized Clinical Trials. JAMA Psychiatry. 2021;78 (5):490-497.

Long Term Follow-Up After Administration of Human Gene Therapy Products. FDA Guidance for Industry January 2020.

Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe. Drug Safety 2021; 44:63–72

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey.

Pharmaceutical Medicine 2019; 33:121–133.

Placebo response rates and potential modifiers in double-blind randomized controlled trials　of second　and newer generation antidepressants for major depressive disorder in children　and　adolescents: a systematic review and meta-regression analysis. 

Eur Child Adolesc Psychiatry 2020;29(3):253-273.

What will the crowd fund? Preferences of prospective donors for drug development fundraising campaigns.  Drug Discov. Today 2016; 21(12): 1863-1868.

Effect of a Pay-for-Performance Program on Renal Outcomes Among Patients With Early-Stage Chronic Kidney Disease in Taiwan.　Int J Health Policy Manag. 2021 Apr 13. 

Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): 

a multicentre, open-label, randomised controlled trial.　Lancet Gastroenterol Hepatol. 2021 Jun;6(6):429-437.

Asia-inclusive global development of pevonedistat: Clinical pharmacology and　translational research enabling a phase 3 multiregional clinical trial.Clin Transl Sci. 2021 May;14(3):1069-1081.

<2020>

Incidence rates of immune-related adverse　events and their correlation with response　in advanced solid tumours treated with　NIVO or NIVO+IPI: a systematic review and meta-analysis.J Immunother Cancer 2019 Dec 4;7(1):341.

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties.　Orphanet J Rare Dis.2018 Nov 15;13(1):206.

Optimal Design of Population-Level Financial Incentives of Influenza Vaccination for the Elderly.　VALUE IN HEALTH. 2020; 23(2):200–208

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Guidance for Industry, Investigators, and Institutional Review Boards March 2020.

Cardiovascular Adverse Events in Patients With non-Hodgkin Lymphoma Treated With First-Line Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) or CHOP With Rituximab (R-CHOP): A Systematic Review and Meta-Analysis.　Lancet　Haematology 2020;7(4):295-308.

Translation of Clinical Research into Practice: An Impact Assessment of the Results from the Blood and Marrow TransplantClinical Trials Network Protocol 0201 on Unrelated Graft Source Utilization.　Biol Blood Marrow Transplant 2018; 24(11): 2204-2210.

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016; 352: i637.

Use of Immunotherapy With Programmed Cell Death 1 vs Programmed Cell Death Ligand 1 Inhibitors in Patients With Cancer. A Systematic Review and Meta-analysis.  JAMA Oncol. 2020;6(3):375-384. 

Use of Real-World Evidence to Support FDA Approval of Oncology Drugs.  VALUE HEALTH.  2020; 23(10):1358–1365.

Achieving equal and timely access to innovative anticancer drugs in the European Union (EU): summary of a multidisciplinary CECOG-driven roundtable discussion with a focus on Eastern and South-Eastern EU countries. 

ESMO Open 2019 Nov13;4(6):　e000550.  doi: 10.1136/esmoopen-2019-000550.

<2019>

Predicting success in regulatory approval from Phase I results. Cancer Chemother Pharmacol. Nov;74(5):1099–103.

Food effect study design with oral drugs: lessons learned from recently approved drugs in oncology. J Clin Pharmacol. 2019 Apr;59(4):463-471.

Association between antidepressant use during pregnancy and autism spectrum disorder in children: a retrospective cohort study based on Japanese claims data. Matern Health Neonatol Perinatol. 2019 Jan;5:1.

Milestone analyses of immune checkpoint inhibitors, targeted therapy, and conventional therapy in metastatic non-small cell lung cancer trials: a meta-analysis. JAMA Oncol. 2017 Aug10;3(8): e171029.

Estimation of clinical trial success rates and related parameters. Biostatistics 2019;20(2):273-286.

Characteristics of single pivotal trials supporting regulatory approvals of novel non-orphan, non-oncology drugs in the European Union and United States from 2012-2016. Clin Transl Sci. 2019 Jul;12(4):361-370.

Inefficiencies and patient burdens in the development of the targeted cancer drug Sorafenib: a systematic review. PLoS Biol. 2017 Feb3;15(2):e2000487.

A Comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance, and why. Clin Pharmacol Ther. 2019 Jul 15. [Epub ahead of print]

Comparison of Population-Based Observational Studies With Randomized Trials in Oncology. J Clin Oncol. 2019 May;37(14):1209-1216.

<2018>

 Correlation of single arm versus randomised phase 2 oncology trial characteristics with phase 3 outcome. European Journal of Cancer 2015; 51(17): 2501-2507.

Does the low prevalence affect the sample size of interventional clinical trials of rare diseases? An analysis of data from theaggregate analysis of clinicaltrials.gov. Orphanet Journal of Rare Diseases 2017; 12: 44.

Clinical and biological effects of demethylating agents on solid tumours - A systematic review. Cancer Treat Rev. 2017; 54: 10-23.

Response rate as a potential surrogate for survival and efficacy in patients treated with novel immune checkpointinhibitors: A meta-regression of randomised prospective studies. European Journal of Cancer 2017; 86: 257-265.

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017; 317(18):1854-1863.

Randomized, Controlled Trials in Health Insurance Systems. N Engl J Med 2017; 377(10): 957-964.

Three-year safety, efficacy and persistence data following　the daily use of mirabegron for overactive bladder in the clinical setting: A Japanese post-marketing surveillance study. Lower Urinary Tract Symptoms. 2018; doi.org/10.1111/luts.12237.

A review of studies evaluating the effectiveness of risk minimisation measures in Europe　Using

the　EuropeanUnion electronic Register of Post-Authorization Studies. Pharmacoepidemiol Drug Saf. 2018; 27(7): 695-706.

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology. A Systematic Review and Quantitative Analysis. JAMA Intern Med. 2018; 178(12): 1586-1596.

Evaluating Safety Reporting in Paediatric Antibiotic Trials, 2000–2016: A Systematic Review and Meta-Analysis. 2018; 78(2): 231-244.

Ethnic Difference in the Pharmacodynamics-efficacy Relationship of Dipeptidyl Peptidase‐4 Inhibitors Between Japanese and non‐Japanese Patients: A Systematic Review. 2017; 102(4): 701-708.

<2017>

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. 2014 Apr 29; (4): MR000034.

Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016; 375(16): 1532-1543.

Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications. PLoS One 2013; 31:8(5):e66116.

Signs and Symptoms of Detrusor Underactivity:An Analysis of Clinical Presentation and Urodynamic Tests From a Large Group of Patients Undergoing Pressure Flow Studies. Eur Urol. 2016; 69(2): 361-9.

Utilization patterns of Antihyperuricemic Agents Following Safety Announcement on Allopurinol and Benzbromarone by Taiwan Food and Drug Administration.  Pharmacoepidemiol Drug Saf. 2014; 23: 309-313.

Psychological distress in relation to site specific cancer mortality: pooling of unpublished data from 16 prospective cohort studies. BMJ 2017; 356: j108.

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ 2015; 351: h4633.

Innovation in the pharmaceutical industry: New estimates of R&Dcosts. Journal of Health Economics 2016; 47: 20-33.

A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

BMC Medical Research Methodology 2017; 17: 108.

Adaptive Dose-Finding Studies: A Review of Model-Guided Phase I Clinical Trials. J Clin Oncol. 2014; 32(23): 2505-11.

Patients' Attitudes towards Generic Substitution of Oral Atypical Antipsychotics. CNS Drugs 2009; 23(8): 693-701.