CII Programs


Below is a detailed description of the programs offered by the CII. For faster access to the program of interest to you, please use the links to the left. There are four types of programs: Education; Clinical Trials; Cores; Translational Research Network; CTAS.





Education


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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CREST: Clinical Research Enhancement through Supplemental Training

A UCSD program that provides comprehensive multidisciplinary clinical research training for future leaders in clinical investigation.
For doctoral candidates, postdoctoral fellows and junior faculty pursuing a career in clinical or translational research.

http://crest.ucsd.edu/


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MAS: Master of Advanced Studies

The UCSD Master of Advanced Studies (MAS) in Clinical Research is a unique program of study that provides depth in the knowledge and skills necessary to perform valid, credible research. The UCSD Office of Graduate Studies and Research confers the MAS degree. The Department of Medicine in the UCSD School of Medicine is responsible for the academic management of the program, while UCSD Extension's Office of Advanced Professional Education and Development administers the program and provides program advising and career counseling services.


Program Objectives and Features

  • Provide a broad-based comprehensive curriculum in clinical research methodology
  • Integrate didactic information with practical training
  • Accommodate students' varying needs by using a modular approach to instruction, a part-time year-round schedule, and a choice of course electives
  • Facilitate interaction among program participants and experienced investigators
  • Link the academic and professional scientific communities


To learn more about MAS, please follow this link:
http://health-execed.ucsd.edu/mas/crprog.html



CII Symposium

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Clinical Trials

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
    Dr Arthur 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
    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
    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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CIT: Center for Innovative Therapy

CIT Mission
We are committed to improving patient health through the discovery and evaluation of innovative therapies for immune-mediated and inflammatory diseases.

We achieve this goal by identifying novel therapeutic targets, facilitating their translation from bench to bedside, and designing and implementing clinical studies. We focus on early proof-of-concept and biomarker-based studies, encouraging investigator-initiated trials, and providing educational opportunities for clinicians and researchers.

For more information, follow this link.


Services

The Clinical Trials Unit provides expertise and resources to support clinical trial design with clinical, imaging, and biomarker endpoints, submission of documents for Human Subjects Research Protection Program approval, creation of appropriate informed consent forms, recruitment of patients for clinical research, organization of multi-center studies, and preparation of investigational new drug applications. Experienced CII faculty members are available to assist trainees and faculty at any stage of their career. Dedicated space in the Thornton Hospital can be provided for patient-related activities. CII Clinical coordinators can assist investigators requiring resources for patient evaluations, maintaining compliance, recording data, and collecting clinical samples.


Ongoing Clinical Trials

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Core Facility and Services:


1. Biomarker Core


BACKGROUND

The Biomarker Core, under the direction of David Boyle, is one of research support services of the CII. Biomarkers are biological indicators that signal a changed physiological state due to disease or a therapeutic intervention. Typical biomarkers include cytokines (e.g., IL-1, TNF-alpha), metalloproteinases and small molecule mediators (e.g., prostaglandins). The availability of biomarker assays has directly led to the need to develop specialized techniques to evaluate their expression in peripheral blood or very small tissue samples from the site of disease. The use of biomarkers in translational and clinical research has dramatically increased because:
  1. The use of biomarkers may greatly reduce the numbers of patients needed to perform significant clinical studies.
  2. The number of potential therapeutic targets far exceeds the capacity to perform trials based on clinical endpoints alone.
  3. The duration of studies using clinical endpoints is typically several months, while a biomarker study often can be completed in 2-4 weeks.

To assist investigators studying novel therapies and the pathogenesis of disease, the CII Biomarker Core will provide specialized support to measure biomarkers in patients and in animal models of disease. Core personnel will establish methodology and perform studies to assess gene expression in clinical and basic science research samples. In specific, the Biomarker Core has been organized to support studies utilizing real time PCR, computer-assisted image analysis, in situ hybridization and quantitative immunohistochemistry. To quantify protein expression, ELISAs and western blot analysis can also be performed. The staff of the Core can also assist investigators in the design and implementation of studies involving the quantitative measurement of protein and gene expression.

For a general discussion of biomarker analysis in clinical trials, see: http://cit.ucsd.edu/level2/biomarker.htm


BIOMARKER CORE SERVICES

  1. mRNA analysis: Real time PCR and in situ hybridization
    Real time PCR represents one of the primary techniques offered to users of the Biomarker Core. Using “Taqman” methodology, a fluorescent signal is generated when an unquenched fluorochrome-labeled oligonucleotide is incorporated into a PCR product. Instead of quantifying the amplified product by gel electrophoresis or isotope incorporation, the fluorescence in each reaction can be constantly monitored in “real time”, enabling the measurement of increases in specific DNA products with each PCR cycle. To perform these studies, dedicated hardware (i.e., Perkin Elmer GeneAmp 5700 Sequence Detector) and software are available. Protocols have been established for the quantitative measurement of a variety of cytokines, and additional custom assays can be developed for each project.
    The Core will assist investigators in the appropriate utilization of this technique, including the design of primers, validation of standards, and assay of test samples. To localize the expression of certain gene in tissue sections or cytospun cell samples, in situ hybridization can be performed as a confirmatory study.

  2. Protein analysis: Immunohistochemistry, ELISA, and western blot analysis
    The Biomarker Core offers several techniques are available to evaluate the expression of molecules involved in inflammation. To assist investigators interested in evaluating the distribution and quantification of proteins in tissues, immunohistochemistry studies can be performed. In addition, western blot and ELISA studies on tissue or cell extracts can be performed to provide quantitative information on protein expression. As with real time PCR, validated protocols have been established for many cytokines and proteases.

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2. Imaging Core


BACKGROUND

The Imaging Core, under the direction of Robert Mattrey, M.D. provides imaging of tissues, animals and human subjects. Imaging has traditionally been to detail organ and tissue anatomy and structure non-invasively. Either with or without the use of contrast media, imaging techniques are used to detect and/or monitor tumors, organs or interventions. In naturally occurring diseases, imaging can also add specificity to recognize benign from malignant lesions and one disease from another. A new paradigm in imaging is emerging that aims to detect receptor up- or down-regulation, reporter gene expression, and specific enzyme activity. This new approach of “non-invasive biomarker assessment” requires the use of “smart” contrast media aimed at detecting receptors or enzymes. When genetically engineered cells express specific receptors or enzymes they can be detected by imaging to locate them or to infer that the reporter gene was activated. The “smart” agents are still under development and will first become available for non-human use.

Non-invasive imaging, particularly when combined with molecular imaging tools, is a powerful technique that not only allows the use of few animals to achieve reliable conclusions, but also allows the detection, recognition and monitoring of disease over time. This adds a new dimension to developing therapeutic techniques because of the ability to optimize the intervention to maximize efficacy in fewer subjects and with faster turn-around time. Further, the same subjects can be used as their own control.


IMAGING CORE SERVICES

  1. Tissue and Rodent Imaging
    CII utilizes the High Resolution Imaging Facility in the new Rebecca and John Moores UCSD Comprehensive Cancer Center under the direction of David Vera, Ph.D. This facility is equipped with a quantitative optical imaging device (eXplore Optix), a high resolution CT scanner (eXplore Locus), a PET scanner (eXplore Vista DR) and a Histological Imaging system BioRad FX-Pro-plus & Vibratome. Except for the BioRad system, the instruments are all provided by GE Healthcare. This facility is adjacent to the vivarium in the basement on the new Cancer Center and utilizes a holding room for animals that leave the sterile barrier or are brought in from other facilities. The optical imager is currently tuned for Cy7 but we will be upgrading the instrument that is multi-channel ready, to be able to image GFP and Cy5.5. We have contrast media that can be used to improve the ability of CT to highlight anatomy and specific contrast media that accumulates in the liver and spleen to detect tumors. Adjacent to the imaging suite, we have a radiopharmaceutical laboratory that can produce F-18 labeled compounds such as FDG to support the PET scanner. F-18 is transported from the UCSD Molecular Imaging Institute in Sorrento Valley for this purpose. To support the histological imaging system, we have a Vibratome that is capable of slicing mice and rats or any tissue up to 25cm in length in thin sections from sub- to 40 microns in thickness. If the animal was injected with radioactive agents, images of each slice can be generated at 50-micron resolution providing a digital autoradiography-like image of each slice. The phosphor plates can detect a wide range of radiation photons including 140keV from 99mTc and 511keV photons from positron emitters. The BioRad FX-Pro-plus is also equipped with lasers to allow the acquisition of tissue fluorescence at high resolution. The nuclear and optical imaged can be co-registered to increase the power of the technique.

  2. MRI imaging
    CII provides the clinical expertise to design the optimal imaging protocols and interpret high-resolution rodent MRI images. This service under the Direction of David Vera, is provided by Miriam Scadeng at the fMRI center and Robert Mattrey. We have a variety of contrast media that can be used with MRI of animals and several approved contrast agents for animal and human use.

  3. Rodent Ultrasound, Large animal and Human Imaging
    This service is provided by Robert Mattrey. The ultrasound service under the direction of Yuko Kono, is currently only available at Hillcrest. Animals larger than rodents and human subjects are imaged on the clinical scanners typically at Hillcrest. We can provide, MRI, CT and ultrasound imaging. Contrast media exists for all these techniques that can be used to better delineate anatomy and disease as well as assess blood flow and fractional blood volume.

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3. Biostatistics:


BACKGROUND

Biostatistics Core expertise greatly enhances the success and quality of science by investigators conducting clinical research. Provided in a timely manner, this expertise involves statistical assistance throughout the research process: designing the statistical component, analyzing the resulting data, and interpreting data for inclusion in peer-reviewed grants and manuscripts. Services are tailored to assist projects in all Divisions of CII investigators, including laboratory and patient-oriented research.


BIOSTATISTICS CORE SERVICES

A variety of services are available to CII investigators through the Biostatistics Shared Resource, directed by Dr. Ron Thomas. Depending on the needs of an individual investigator, the Core can assist with:

  1. Design of pilot or feasibility studies
  2. Experimental and protocol design
  3. Analytical plans
  4. Customized analytical procedural approaches
  5. Data analysis
  6. Assists in manuscript preparation and revision regarding statistical methods, data presentation, and interpretation of results
  7. Continuing education to investigators

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Translational Research Network

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.


Immunology Advanced Center On Preclinical immunOgenomics


The area of intervention: bridging the gap between basic science and clinical medicine

Translational medicine is represented by the itinerary that goes from conception of an idea in the area of molecular therapeutics to its development into clinical testing, with the final objective of creating new therapies for human diseases. This area requires a broad range of diverse expertise, ranging from molecular medicine to development and protection of intellectual property, identification of funding sources, design of preclinical studies for development and validation of the idea, relationship with regulatory agencies and clinical trial design. There is currently a significant disconnect among the various components of this itinerary. The outcome of this disconnect is a significant delay, and often failure, in completion of the itinerary from research to therapeutics. Unfortunately, there is no formal training available to create a professional figure capable of acting as interface among the various components of this itinerary. In order to facilitate focused and effective development and ultimately shorten the time and reduce the amount of resources needed.


Mission

Our fundamental mission is to create a network of excellence in the area of translational medicine. This network will comprise of outstanding individuals and institutions willing to contribute to progress in the area, with the ultimate goal to optimize the development of new therapies for human diseases. We will have an Educational and Research arm.

To see a similar project in the private sphere, see:
www.eurekainstitute.org

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CTAS


Clinical Trials Administrative Services and Research Compliance Office

Clinical Trials Administrative Services and Research Compliance Office (CTAS) is dedicated to serving the needs of researchers and industry through a commitment to excellence and a guarantee of timelines, performance and reliability.  The CTAS serves as the liaison for sponsors with UCSD administrative offices and principal investigators to ensure clinical research is initiated and conducted efficiently, effectively and in compliance with applicable standards.   The CTAS provides comprehensive services that enhance clinical investigation, including:

  1. Clinical trial contract negotiation with industry
  2. Regulatory compliance
  3. Clinical trial financial management
  4. Research staff education and training programs

If you are on the UCSD campus (or using the proxy), please click here for more information

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