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Important Notice
As of November 1st, 2015, The Center for Clinical Research, Keio University School of Medicine (Keio CCR) has transferred all the functions and activities to Clinical and Translational Research Center (CTRC), a program of Keio University Hospital. Keio CCR now serves as a clinical research division of KUH-CTRC.

Keio Centre for Clinical Research (CCR)

Hitherto established functions, partnerships and achievements
As of April 2013

(1) History, organizational and functional developments so far

Keio CCR was founded in 2006 as an academic research organization within Keio University School of Medicine under the auspices of the Ministry of Health, Labour and Welfare to assume a leading role in national improvement of clinical trial infrastructure. In 2009 Keio was designated by MHLW as one of the only two centres of excellence to promote global clinical research. In 2011, Keio was again designated by MHLW as one of the Early- and Exploratory Phase Clinical Trial Sites (in the field of refractory immune disease. The Annual budget of CCR amounts to some 3.5 million yen in 2010. Over the last 6 years, CCR has newly appointed clinical trial specialists, including data managers, biostatistician, trial coordinators and regulatory scientist, many of whom with industry experiences, thus well versed in clinical research operations. At the moment, some 50 members at CCR provide the following ervices in-house, and are dealing with ca 45 non-IND trials (cf. Attachment 1 (Ongoing clinical research at Keio supported by Keio CCR) and Attachment 2(Operational improvement in clinical trial implementation at Keio) shown below).

  1. Planning and supporting investigator-initiated IND clinical trials
  2. Planning and supporting investigator-initiated non-IND clinical trials and observational clinical research
  3. Support for industry-sponsored translational research, registration trials/post-marketing clinical research by industry
  4. Support of industrial R&D activities related to drugs, medical devices and diagnostics
  5. Project management and assistance for investigators regarding contractual and financial issues with domestic and overseas extramural industries
    • - Support of the patient recruitment and retention service
    • - Provision of Visit Reminding System which alerts scheduled visit and observation items in advance of the actual patient visit
  6. Clinical data management, including data registry implementation
    • - Provision of web-based case report form and data collection
    • - Randomization and case registration services
    • - Enrollment monitoring and encouragement towards participating investigators nationwide
    • - Consultation of manufacturing placebo and packaging, labeling of the research drugs
    • - Immediate reporting of serious adverse events and safety management
  7. Biostatistical support
    • - Consultation on biostatistical issues in clinical studies (e.g. sample size calculation, selection of endpoints and statistical methodology etc)
    • - Planning and provision of statistical analysis
    • - Co-authorship of statistical portion in academic papers to meet scientific standard of first-class international journals
    • - Giving lectures on biostatistics to medical students and researchers
  8. Education and human resource development for clinical research
    • - Introductory lecture series on clinical research, twice annually
    • - Registration of the investigators’ completion of the training course on clinical research
    • - E-learning authoring on ICH-GCP and other clinical trial requirements in association with the University of Minnesota Academic Research Center
    • - Medical English training course for beginners and advanced learners
    • - Individual consultation and supervision on investigator-initiated clinical research
  9. Liaison service with industry for partnership to improve sponsored clinical research
    • - Assistance for agreements, contracts and alliance
    • - Assistance for identifying recommended investigational sites through representative Keio physicians
    • - Establishing central co-ordinating/supervising functions within Keio to oversee multinational/multicentered clinical trials regarding enrollment, screening, investigator trainings
  10. Operation of Keio University Hospital Registration Trial Office (from April 2011)
    • - In average 5 to 6 new protocols are handled by Keio CCR’s experienced and efficient staff.
    • - Currently manages approximately 100 protocols in wide variety of fields.
  11. Support for operation of the Ethics Committee, Keio University School of Medicine
    • - Pre-review process
    • - Consultation assistance for administrative office.
  1. Operational improvements
    • - Acceleration of IRB application and approval process
    • - Assistance of pre-IRB approval set-up for incoming clinical trials to enable quicker FPI
    • - Wider and more flexible assistance from clinical research coordinators
    • - Improvement of study budget calculation for sponsored registration trials
    • - Intradepartmental coordination for trials involving multiple therapeutic areas
    • - Securing wider and more flexible space allocation for source document verification
      1. Full implementation of Electronic Health Record system for SDV (Jan. 2012)
      2. Ample EHR terminals and spaces for SDV.
    • - Preparation of per-patient per-visit study budget calculation format with a global industry
    • - SMO support (Japan Bridge Solution, JBS) for further operational improvement from August 2010
  2. External partnerships
    1. Master agreement with Astra Zeneca (global HQ) regarding preclinical, translational and clinical joint research
      • - Contracted feasibility study for accurate enrollment projection in haematology/oncology area
      • - Provision of central coordination/case registration function for a Phase II global trial in critical care medicine
      • - Co-development of per patient per visit study budget calculation system
      • - Sponsored translational research in oncology
      • - Provision of clinical coordinating center function for a domestic Ph-II trial.
    1. Eisai: Central coordination function in critical care medicine for a Ph-III global trial
      • Liaison with the same functions in American and European AROs
    1. Contractual post-approval comparative clinical trials, thereby abolishing donation-based trials (Janssen, Bristol-Meyers Squibb, Kyorin, ,GSK, Novartis)
      • Three multi-centre trials in oncology
      • One multi-centre trial in autoimmune disease area
      • International epidemiology study in hematology
      • One multi-centre trial in cardiovascular disease area
    1. Comprehensive trial support for comparative trials based on donation-grant (Takeda, Eisai, Tsumura, Ajinomoto, JIMRO among other domestic companies)
    1. Partnership with overseas Academic Research Organisations
      • Collaboration with Clinical Trial Network Institute (a part of Harvard Clinical Research Institute) on an industry-sponsored multinational trial in CNS area, to assume Japanese central coordination/screening function
      • Collaboration with Ocean State Clinical Coordinating Center, Rhode Island Hospital, on two industry-sponsored multinational trials in critical care medicine area, to assume Japanese central cooridation/screening function
      • Collaboration with the Academic Health Centre, University of Minnesota to develop e-learning courseware on ICH-GCP, under the research grant from the Medtronic Foundation
    1. Partnership with ICON Japan: Keio physicians’ medical input for clinical judgment in pharmacovigilance
    1. Partnership with Gleneagles CRC( Singapore-based CRO affiliated with Parkway and Mitsui-bussan) for future collaborative operation in Asian multinational trials

[Attachment 1] Ongoing Clinical Research at Keio supported by Keio CCR

As of March 2012

  1. Long-term comparative trial for antihypertensive agents
  2. A comparative trial on chronic hepatitis
  3. Endoscopic biopsy trial for inflammatory bowel disease
  4. Post-operative trial on Crohn's disease
  5. Comparative trials on relapse ovarian cancer: contract clinical trial
  6. Comparative trial on functional dyspepsia
  7. Steroid-induced osteoporosis
  8. Pulmonary hypertension associated with autoimmune diseases
  9. Comparative oncology trial on non-small cell lung cancer
  10. Comparative trial on the effect of a new rehabilitation program for ambulatory disability
  11. Trial on dose-reduction of antipsychotic agents for schizophrenia
  12. Chemotherapy trial for esophageal carcinoma
  13. Comparative chemotherapy trial for colorectal cancer
  14. Observational study on gastrointestinal complication by low-dose aspirin after Ml/stroke
  15. Comparative chemotherapy trial for Ovarian cancer
  16. Multinational trial to assess diagnostic reliability of radiological procedure
  17. Trial to assess diagnostic reliability for HPV
  18. Comparative trial on metastatic brain tumor {operation plus Irradiation}
  19. Evaluation of therapeutic effect for lumbar spinal canal stenosis by a novel computerized gait analyzer
  20. Analysis of statin treatment and its vascular effect on generalized scleroderma
  21. Randomized clinical trial of a device for granulocyte apheresis for inflammatory bowel disease
  22. International registration RCT of an immune response modifier for acute sepsis
  23. Clinical trial of a novel anti-hyperglycemic agent on cardiac function for CHF with Type2-DM
  24. Observational study for RA treated with a molecular-targeted agent.
  25. Multi-centered double-blinded placebo-controlled RCT of an oriental medicine for functional dyspepsia (Study-I/II)
  26. Clinical trial of dendritic cell treatment combined with chemotherapy for advanced pancreatic carcinoma
  27. Phase-2 domestic registration clinical trial of a novel immune modulator for severe sepsis
  28. Clinical trial of an antibody drug combined with immunomodulatory agents for Crohn’s disease.
  29. A multi-centre prospective disease registry for adult ITP
  30. Phase-2 clinical trial of novel combination chemotherapy for non-Hodgkin lymphoma
  31. An investigator-initiated registration phase-3 trial of an antibody drug for adult ITP
  32. International RCT of SSRI treatment regimen for major depression
  33. Observational study on cardiac function of DM with chronic heart failure treated with a novel anti-DM agent
  34. Registry study of orthopedic disease and interventions
  35. Clinical trial of dendritic cell treatment combined with chemotherapy for advanced or recurrent esophageal carcinoma
  36. Clinical trial of an off-label an anti-pneumococcal vaccine for elderly
  37. Phase-1/2 clinical trial of dendritic cell treatment combined with chemotherapy for malignant melanoma
  38. Clinical trial of a novel endovascular LASER treatment device for varicose veins
  39. Phase-I Clinical trial of a novel intervention for acute MI
  40. Clinical trial of a high-dose antibody treatment for RA
  41. Clinical trial of an anti-hyperlipidemic medication and its effect on inflammation and coronary endothelial function upon PTCA
  42. Multi-centered randomized placebo-controlled double-blinded clinical trial of an oriental medicine for moderate Crohn’s disease.
  43. Clinical trial of peripheral hematopoietic stem cell transplantation combined with an antibody drug and corticosteroid for de novo multiple myeloma
  44. Double-blinded randomized placebo-controlled clinical trial of an herbal medicine for PPI-resistant functional dyspepsia
  45. Clinical trial of an oriental drug for adverse symptoms caused by hormonal therapy as a post-operation treatment for breast carcinoma

[Attachment 2] Operational Improvement in Clinical Trial Implementation at Keio

As of March 2013

(1) Performance of Registration Trial (Keio University Hospital, FY2006-2012)

Performance of Registration Trial

(2) Key Metrics for Registration Trial  (Keio University Hospital, FY2006-2012)

Key Metrics for Registration Trial

(3) Non-IND Clinical Research (Keio University School of Medicine, FY2006-2012)

Non-IND Clinical Research

(4) Non-IND Clinical Research supported by Keio CCR DM/PM division (FY 2006-2012)

Non-IND Clinical Research Support provided by Keio CCR DM/PM

(5) Support provided by Keio CCR Biostat division (FY 2010-2012)

Support provided by Keio CCR Biostat