Organization of the CII


The CII is a key element in COILS that serves as a link between basic biology and patient care. The Institute is organized into five units that provide support multidisciplinary translational research. Below is a detailed description of those units. For faster access to the unit of interest to you, please use the links to the left.



  1. Clinical Trials Unit
    The Clinical Trials Unit (CTU), under the direction of Dr. Artie Kavanaugh, is the division of the CII that interacts with and assists CII members conducting clinical research or clinical trials. The CII/CTU has as its primary goal the provision of expertise and a complete menu of options to support, facilitate and optimize the conduct of clinical research projects. An important ancillary goal will be to help young clinical investigators develop clinical research experience and expertise. In order to achieve these goals, the CII/CTU will work very closely with the other CII units, especially the education unit, the biomarker and imaging cores, and the Clinical Trials Administrative Support office.
    For clinical investigators, the CII/CTU can offer assistance at all phases and stages of clinical research projects (see Figure). Based upon their own experience, resources, and available effort, investigators may choose a few focused areas for collaboration or they may choose more extended CTU involvement that could involve all aspects of a study. Some of the specific resources available include:

    1. Study Planning and Design
      Contacts: Dr. Susan Lee (email Dr. Susan Lee)
      Dr Arthur Kavanaugh (email Dr. Kavanaugh)
      Planning for single-center or multiple center clinical studies can be initiated with the CTU. For investigator-initiated studies, the key initial step in beginning clinical research is the design of a protocol that is scientifically rigorous, ethically appropriate, statistically sound, and clinically feasible. Assistance with protocol design is available through the CTU. For novel studies, submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) may be required; this can be done through the CTU. For all studies, submission of the protocol to the UCSD Human Research Protections Program (HRPP) is required; clinical research coordinators experienced in this process are available through the CTU. The informed consent document is the most tangible aspect of appropriate and ethical clinical research. For investigator-initiated studies, CTU staff can assist in the development of an appropriate informed consent form. For sponsored studies, transformation of the sponsor-generated informed consent into a format appropriate for the UCSD HRPP is required; this sometimes requires negotiation with the sponsor or with the Clinical Research Organization (CRO) working for the sponsor. Staff with years of experience in this type of interaction is available to assist the investigator. Likewise, a budget that is acceptable to the sponsor but adequate for the conduct of the research must be negotiated. Creation of source documents and case report forms to capture the information relevant to the study can also be done through the CTU. Once a study is designed, and approved, the CII/CTU can aid in patient recruitment. A central goal of the CII is to facilitate excellent translational research; therefore, the CTU will work closely with other CII units to assist the clinical investigator in the design and conduct of translational studies to be done in conjunction with clinical trials.

    2. Conduct of Clinical Studies
      Contact: Dr. Susan Lee (email Dr. Susan Lee)
      As with study design, the CTU offers investigators a menu of options related to the actual conduct of clinical research. For researchers desiring more complete service, the CTU can arrange scheduling of visits, conduct of visits, data and specimen collection, and determination of safety for research patients. Moreover, in conjunction with the ither CII units, creation of database for clinical data can be collected. With an increased focus on safety of subjects in clinical research, CTU staff is experienced and adept at rigorous monitoring for adverse events, more general aspects of study monitoring.

    3. Study Analysis and Interpretation
      Contact: Dr Arthur Kavanaugh (email Dr. Kavanaugh)
      In collaboration with the other CII units, in particular the Biostatistics Core, the CTU can assist in analysis of data from clinical studies, creation of plans for further clinical and translational studies, and also in publication of data from research studies.

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  1. Education Unit
    The Education Unit develops programs to enhance training in patient-oriented research. The NIH-funded Clinical Research Enhancement and Supplemental Training (CREST) program serves as the cornerstone of CII educational activities and offers a modular didactic educational opportunity. CREST provides training in many areas as part of a two-year curriculum that includes biostatistics, clinical trial design, epidemiology, and many other areas. A Masters of Advanced Studies degree is also available to qualified individuals who desire a more in-depth experience. CREST enrollment is available to students, trainees, and faculty at UCSD as well as selected individuals from the private sector and other academic institutions.
    The Education Unit serves as an entry point for young investigators seeking a career in clinical investigation, including didactic training, practical experience, and assistance with preparing mentored grant applications. As part of their educational experience, trainees may transition to the Clinical Trials Unit in order to support the next phase of their career.  The Education Unit is developing several additional initiatives to enhance training opportunities, including:

    1. Web-based instruction
    2. Pilot project grants for trainees and junior investigators
    3. Seminar series
    4. Clinical Investigation Symposium

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  2. Core Unit
    The CII Core Unit provides expertise and specialized services to clinical investigators at UCSD and the surrounding community. Three Core facilities are available:

    1. Biostatistics
      Contact: Dr. Ronald Thomas (email Dr. Thomas)
      A team of biostatisticians is available for consultation and collaboration.  The Biostatistics Core can assist with power calculations, clinical trial design, and data analysis.  Access to the UCSD Supercomputer Center can provide sufficient computing power for data intensive studies, such as those involving the human genome, proteomics, or DNA microarrays.

    2. Biomarker
      Contact: D. Boyle (email D. Boyle)
      The CII Biomarker Laboratory provides expertise in the analysis of clinical samples, especially as a component of proof-of-concept trials that focus on non-clinical endpoints. Validated assays involving real time PCR, multiplexed protein immunoassays, in situ hybridization, and immunohistochemistry can be used in clinical trials to evaluate the biological effects of novel therapeutic interventions.

    3. Imaging
      Contacts: Dr. Robert Mattrey (email Dr. Mattrey)
      Dr. David Vera (email Dr. Vera)
      The Imaging Center is developing novel technology and imaging agents that will be used to assess disease pathogenesis or the effects of a therapeutic trial. For instance, power doppler ultrasound can be used to evaluate blood flow. New imaging techniques will be used assess angiogenesis, inflammation, and in vivo enzyme activity in patients.

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  3. Translational Research Unit
    The Translational Research Unit facilitates interactions and collaborations between pre-clinical laboratory investigators as well as between UCSD faculty and private sponsors. Training opportunities in disease-oriented pre-clinical research are available for individuals seeking an experience in laboratory investigation.  Web-based information systems provide access to laboratory protocols, determine availability of unique reagents, track clinical samples that can be used in pre-clinical research, and initiate collaborations. Interactions with the Education and Clinical Trials Unit can facilitate translation of scientific discoveries into therapeutic trials as well as encourage trainees to integrate laboratory and patient-oriented research.

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  4. Infrastructure Support Unit
    An administrative unit will generally be responsible for integrating the CII activities as well as support website development, triage of requests from private sponsors for potential clinical trials or pre-clinical target validation studies, distribute a newsletter, and assist with contract negotiations.  The Central Clinical Trials Office (CCTO) is an integral part of the CII Infrastructure Support Unit.  The CCTO performs many critical functions that enhance clinical investigation, including:

    1. Developing budgets for clinical trials
    2. Assisting with clinical trial recruitment through advertising
    3. Assuring regulatory compliance
    4. Assisting with contract negotiations with private sponsors
    5. Accrediting clinical coordinators

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CII Governance

The Director and the Executive Committee governs the Institute, with input from an Advisory Board and the Vice Chancellor for Health Sciences.  The Executive Committee of the CII includes the Director, who serves as the chair of the Committee, and the leaders of the CII units. An Advisory Board consisting of individuals from the Vice Chancellor for Health Sciences office, senior academic investigators, industry representatives and members of the public helps establish priorities and provides feedback on the progress of the Institute.


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