これまでの実績

Keio Centre for Clinical Research (CCR)

Hitherto established functions, partnerships and achievements
As of August 2010

(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. The Annual budget of CCR amounts to some 3.5 million yen in 2010. Over the last 4 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 30 members at CCR provide the following ervices in-house, and are dealing with ca 20 non-NDA trials*(cf. attachment 1).

  1. Planning and supporting investigator-initiated non-NDA clinical trials and observational clinical research
  2. Support for industry-sponsored translational research, registration trials/post-marketing clinical research by industry
  3. Support of industrial R&D activities related to drugs, medical devices and diagnostics
  4. Project management and assistance for investigators regarding contractual and financial issues with domestic and overseas extramural industries
  5. 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
  6. Biostatistical support
    • Sample size estimation
    • Planning and provision of statistical analysis
    • Co-authorship of statistical portion in academic papers to meet scientific standard of first-class international journals
  7. 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 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
      * Apart from these non-NDA clinicalresearch, ca 100 registration trials are being handled by the Keio university hospital registration trial office(to be united with CCR from April 2011).
  8. 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

(2) Hitherto formed contracts with extramural bodies and operational achievements

  1. Operational improvements
    • Acceleration of IRB application ? 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
    • 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
    2. Eisai: Central coordination function in critical care medicine for a Ph-III global trial
      • Liaison with the same functions in American and European AROs
    3. Contractual post-approval comparative clinical trials, thereby abolishing donation-based trials (Janssen, Bristol-Meyers Squibb, Kyorin)
      • Three multi-centre trials in oncology
      • One multi-centre trial in autoimmune disease area
    4. Comprehensive trial support for comparative trials based on donation-grant (Takeda, Eisai, Tsumura, Ajinomoto, JIMRO among other domestic companies)
    5. 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 system on ICH-GCP, under the research grant from the Medtronic Foundation
    6. Partnership with Icon Japan: Keio physicians’ medical input for clinical judgment in pharmacovigilance
    7. 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 CCR as of August 2009.

Attachment 2. Operational improvement in clinical trial implementation between 2007 through 2008