The mission of TRAD is to respond to the passion of researchers who challenge themselves to establish new treatments for diseases with unmet medical needs, and to help the synergetic development of basic science and clinical science for multidisciplinary research.

Despite the increasing progress in medicine, there are still many diseases for which no effective treatments exist. One of our aims is to address such unmet medical needs in clinical practice and promote the development of new therapies through translational research for future patients.
We also aim to support the dissemination of scientifically high quality information derived from clinical research to the world.

YOKOTE Koutaro, MD, PhD
Translational Research and Development Center
Chiba University Hospital


We provide comprehensive clinical trial support services for investigators who wish to initiate their studies. We aim to leverage their ideas towards success of trials, and provide assistance for compliance with applicable laws or other guidelines.

Our physician-scientists and expert staff provide our best knowledge for advice on:

  • Developing a protocol, including the evaluation of effective endpoints to prove the scientific rationale of the study scheme
  • Customizing the study design based on real clinical settings
  • Upgrading the quality of a study protocol
  • Improving safety for research participants
  • Systematic identification of applicable regulation and guidelines
  • Administrative procedures required for IRB/IEC/CRB application
  • Financial issues
  • Methodological issues


  1. step01

    Planning and
    Research of Clinical Research
    Receive proposal of investigator’s idea and develop synopsis

  2. step02

    Consultation with Staff Discuss research design, clinical protocol, and understand regulations

  3. step03

    Request to Review Committees Discuss application process to IRB/IEC/CRB


Name Position
Yokote KoutaroMD, PhD, Director, ProfessorDiabetes, Metabolism and Endocrinology
Maeda ToshiroMD, PhD, ProfessorGeneral Internal Medicine
Sugawara TakeshiMD, PhD, Vice Director, Associate ProfessorOphthalmology
Furuta ShunsukeMD, PhD, Associate ProfessorAllergy and Clinical Immunology
Kanazuka Aya MD, PhD, PGDip, Assistant ProfessorOrthopedics
Saito GoMD, PhD, Assistant ProfessorRespiratory Medicine
Ishii Arata MD, PhD, Assistant ProfessorHematology
Sato HironoriMD, PhD, Assistant ProfessorPediatrics
Nakada HiroyukiMS, Manager 
Morimoto MinakoBS, Technical Assistant 



Number of Studies Supported by TRAD
Since September 2018, the number of requests made to TRAD for scientific advice on studies has been increasing monthly. To this date, TRAD has been devoted to the improvement of study design for more than a total of 120 investigator-initiated studies.

Cumulative number of projects consulted with TRAD


A clinical trial life cycle consists of various stages.
TRAD provides support services throughout the life cycle including consultation about:

  • StageⅠ
    Rationale of concept, feasibility, and ethical issues
  • StageⅡ
    Study design, schedule, regulatory issues, roles/responsibilities
  • Stage III and IV
    Administrative procedure, systematic identification of issues, and suggestions for solutions


TRAD has provided scientific and regulatory advice and support to investigators conducting clinical studies in compliance with regulations and other ethics guidelines. The clinical trials supported by TRAD are mainly conducted in accordance with the Clinical Trials Act. The Clinical Trials Act, became effective in April 2018, and applies to trials categorized as “specified clinical trials”.
The following table shows the studies conducted at Chiba University under the Clinical Trials Act, also including the studies which have been supported by TRAD.


NO. Dept. Title jRCT Link TRAD Support
Allergy and Clinical Immunology Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis (OPTIWIT) Link
Ophthalmology Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema Link
Esophageal-Gastro-Intestinal Surgery Examination of the usefulness of the sentinel lymph node navigation for esophageal cancer (SN-EC-Chiba) Link
Esophageal-Gastro-Intestinal SurgeryExamination of the usefulness of the sentinel lymph node navigation for esoagogastric junctional cancer (SN-JC-Chiba)Link
HematologyThe feasibility study of elotuzumab/lenalidomide maintenance therapy in patients with multiple myeloma after autologous stem cell transplantation: a phase 2 study (EL-M study)Link
GynecologyExploratory study on the anti-proliferative effects of metformin on endometrial cancerLink
NeurologyOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisLink
Cardiovascular MedicineAssessment of Fractional Flow Reserve Using Intraluminal Blood Speckle Observed by Integrated-Backscatter Intravascular UltrasoundLink
GastroenterologySafety and efficacy of regorafenib in advanced hepatocellular carcinoma patients who were not included in the RESORCE trialLink Yes
GastroenterologySafety and efficacy of lenvatinib in Child-Pugh A and B patients with advanced hepatocellular carcinoma including high burden of intrahepatic tumor (LAUNCH)Link Yes
GynecologyIndocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory studyLink
Esophageal-Gastro-Intestinal SurgeryTAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer (SOAC1701)Link
Diabetes, Metabolism and EndocrinologyEffectiveness and safety of Combination therapy of Ranibizumab and LuseOgliflozin in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial (COMET Trial)Link
GastroenterologyA randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinomaLink
Plastic, Reconstructive and Aesthetic SurgeryComparative test on the effectiveness and safety of B blocker topical treatment with different concentrations of active ingredients against superficial infantile hemangiomaLink
UrologyEfficacy and Safety of Ra-223 as 1st line therapy in combination with alternative anti-androgen therapy for bone metastatic CRPC PatientsLink
HematologyPhase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for multiple myelomaLink
HematologyPhase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for POEMS syndromeLink
Japanese-Oriental (Kampo) MedicineParallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy (Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation)Link
HematologyThe prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT (Chiba AFO-01 study)Link
Esophageal-Gastro-Intestinal SurgeryA randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer (SOAC-1101)Link
General Surgery, Hepato-Biliary-Pancreatic UnitA phase II trial of Down staging Chemotherapy with Nab-paclitaxel plus Gemcitabine in patients with locally advanced pancreatic cancer (CAP-005)Link
Cognitive Behavior Therapy CenterFalse Safety Behavior Elimination Therapy for Generalized Anxiety Disorder-Randomized Clinical Trial Comparing Cognitive Behavioral Therapy and Pharmacological Treatment. (A pilot study of Cognitive Behavioral Therapy for Generalized Anxiety Disorder.)Link
Clinical PsychiatryAn open-label, randomized controlled study evaluating the effectiveness of Pramipexole extended-release tablets for tardive dystonia patientsLink
Cardiovascular MedicinePerformance Evaluation of cardioREPO in stress myocardial perfusion scintigraphy for patients with ischemic heart diseaseLink
DermatologyA comparative study of erythema reaction using ultraviolet therapy devices with different irradianceLink
Esophageal-Gastro-Intestinal SurgeryFOLFIRI3 plus panitumumab or FOLFIRI3 plus bevacizumab as consolidation chemotherapy after preoperative chemoradiotherapy in patients with locally advanced rectal cancer; a phase II trialLink
PediatricsAscorbic acid treatment for childhood Charcot-Marie-Tooth disease 1A (Ascorbic acid for CMT1A)Link
GastroenterologyUsefulness of nasal pressure monitor for sedation in invasive endoscopic procedure:A randomized controlled trial (UNSTOP trial)Link Yes
Diabetes, Metabolism and EndocrinologyProspective, single-center, cross-over trial to verify safety and effectiveness of nicotinamide riboside and pterostilbene for patients with Werner syndrome (EMPOWER)Link Yes
Rehabilitation MedicineSafety and efficacy of Mechanical in-exsufflation for prevention of ventilator-associated pneumonia in an intensive care unit: A single center clinical trialLinkYes
GastroenterologySingle arm study to evaluate the safety and efficacy of ramucirumab in patients with advanced hepatocellular carcinoma after failure of lenvatinib treatmentLinkYes
GynecologyWeekly liposomal doxorubicin and cisplatin chemotherapy for patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, phase I studyLink
Cardiovascular SurgeryThe use of wristband type continuous pulse measurement device with artificial intelligence for early detection of paroxysmal atrial fibrillationLinkYes
Respiratory MedicineEffect of combination of atomoxetine and oxybutynin for Japanese patients with obstructive sleep apnea syndrome
(Effect of combination treatment of atomoxetine and oxybutynin for Japanese patients with obstructive sleep apnea syndrome)
Cognitive Behavior Therapy CenterEffectiveness of eye-contact training devices for social anxiety disorder: a pilot studyLink
GastroenterologySafety and efficacy of glecaprevir and pibrentasvir in patients with hepatitis C virus infection and end-stage renal disease undergoing dialysis; a prostective studyLinkYes
Japanese-Oriental (Kampo) MedicineRandomized controlled trial of prevention for COVID-19 with Kampo medicines (IMJEDI-P1 Study)Link
Respiratory MedicineExamination of the usefulness of pulmonary ventilation and circulatory disorder evaluation technology using a dynamic flat-panel detector system for patients with pulmonary hypertensionLink
Neurological SurgeryConfirmation of safety for patients with traumatic brain injury by transcranial direct current stimulation (TDCSTBI)LinkYes
Orthopedic SurgeryClinical effect of NTN tablets on lumbar spinal canal stenosis with low back pain
-Multicenter,Randomized,Active-control open-label trial-
Respiratory MedicineEffects of olfactory stimulation by L-menthol on dyspnea on exertion in chronic lung disease: A pilot studyLink Yes
GastroenterologyMulticenter prospective randomized controlled trial of Vonoprazan and Esomeprazole in initial treatment for reflux esophagitis: Focusing on recurrence during maintenance therapy (VERET study)Link Yes
Pediatric SurgeryProspective study of bezafibrate for post operated bilirary atresiaLink Yes
NeurologyMulticenter prospective registration and intervention studies for chemotherapy-induced peripheral neuropathy (MiroCIP Study)Link Yes
OphthalmologyProspective clinical trial on the safety and efficacy of anti-VEGF treatment combined with vitrectomy for diabetic macular edema with insufficient effect of anti-VEGF treatment (Eyl/ Vit trial)Link Yes
Allergy and Clinical ImmunologyEvaluation for the non-inferiority between bisphosphonate monotherapy and bisphosphonate plus active vitamin D for preventing glucocorticoid induced osteoporosis in Japanese patients with systemic autoimmune diseases; An open-label, multicenter, randomized controlled studyLink Yes
Respiratory MedicineExamination of the usefulness of a dynamic flat-panel detector system for patients with chronic pulmonary obstructive disease under the treatment with Tiotropium/OlodaterolLink Yes
Allergy and Clinical ImmunologyA single-arm, phase II study to evaluate the effect of low-dose atovaquone on the prevention of pneumocystis pneumonia in patients with rheumatic diseases treated with corticosteroidsLink Yes
Esophageal-Gastro-Intestinal SurgeryA clinical trial to evaluate the usefulness of intraoperative intestinal blood f low assessment using an endoscope for the gastrointestinal tractLink Yes
Japanese-Oriental (Kampo) MedicineRandomized controlled trial of herbal medicine (JPS Gorei Ouge) administration effect related to alcohol metabolism in healthy subjectsLink
GynecologyBevacizumab combined chemotherapy with gemcitabine and irinotecan in patients with platinum-refractory/resistant ovarian, fallopian or primary pe ritoneal cancer: a phase II trialLink
OphthalmologyA double-blinded, randomised, clinical trial about the effect of rebamipide ophthalmic suspension in dry eye with the Sjogren syndrome patients. (Mucosta trial)Link Yes
Respiratory MedicineTolerability of oral nutrition supplementation for interstitial lung disease with a tendency toward weight lossLink
Breast SurgeryAssessment of AI Breast (Anatomical Intelligence for Breast) Accuracy and ReproducibilityLink
Pediatric SurgeryOral selenium supplementation study for selenium-deficiency patient with intestinal failureLink Yes
NeurologySafety of combination therapy of robot suit HAL and repeptive transcranial magnetic stimulation for freezing gait of Parkinson diseaseLink Yes
Cardiovascular MedicineRandomized, open-label, controlled study to evaluate the efficacy of angiotensin receptor neprilysin inhibitor in patients with aortic stenosis undergoing transcatheter aortic valve implantation.Link
Respiratory MedicineA Randomized phase II trial aimed to assess the usefulness of the francine needle in endobronchial ultrasound-guided transbronchial needle aspiration or biopsyLink Yes
PediatricsStudy of the Effect of Combined Use of Vitamin D in Low-dose-oral immunotherapy for Children with Cow's Milk Allergy Double-Blind, Randomized, Placebo-Controlled TrialLink Yes
GastroenterologyThe investigation of prophylactic clip hemorrhage control for colorectal cold snare polypectomy in patients taking anti-thrombotic drugs. (PERCOLD study)Link Yes
General Thoracic SurgeryA Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resection (Trial of Evaluating of Air Leakage using Staple Line Reinforcements)Link Yes
PediatricsAn Explorative Study for Finding Optimal Indication Criteria for Immunomodulatory Therapy in Patients with Kawasaki Disease (FORKiDs trial)Link Yes
NeurologyAge related cerebral perfusion difference and safty in normal adult study by 123 I-IMP SPECT.Link Yes
GynecologyA sham-controlled, double-blind and parallel-group study of the efficacy and safety of AT-04 for endometriosis Phase IIILink Yes
Neurological SurgeryFeasibility Study to confirm the decision to skip post-dilation after Carotid Artery Stenting with the Casper Rx by intravascular ultrasound and angioscopyLink Yes
Esophageal-Gastro-Intestinal SurgeryA single-center, single-group exploratory study to investigate whether one-time administration of mixture of RI colloid and dye is as tolerable as standard separate administration of the two drugs for sentinel lymph node navigation in gastric cancer surgeryLink Yes
Respiratory MedicineEfficacy of oral nutritional supplementation for interstitial lung disease with a tendency to weight lossLink Yes
General Thoracic SurgeryA Single-Center Prospective Randomized Controlled Trial to Evaluate the Prevention of Postoperative Adhesions by Applying Regenerated Oxidized Cellulose Sheets to the Parietal Pleura of Open Chest Wound in Thoracic SurgeryLink Yes
Diabetes, Metabolism and EndocrinologySingle-center exploratory study: Evaluation of therapeutic impact GLP-1 a gonist on glucose and lipid metabolism and fatty liver disease in obesity u sing genomic informationLink Yes
Japanese-Oriental (Kampo) MedicineAn exploratory, single-arm, externally controlled comparative study to evaluate the efficacy and safety of adverse reaction of vaccine prophylaxis for combining maoto and eppikajutsuto in subjects planning to receive the new COVID-19 vaccineLink Yes
OphthalmologyExploratory clinical study for early detection of glaucoma using novel evaluation device. Link Yes


Please contact us if you would like to learn more about our research services.

Chiba University Hospital
Translational Research and Development Center (TRAD)
trad-project*chiba-u.jp (Please replace * with @)
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan