Have ability to support PhD scientists (and their trainees) in accessing human subjects when they want to test a hypothesis in the clinic.
Have a center with resources that will permit a scientist to carry a new therapeutic concept into humans with full support for IND application, study conduct under Good Clinical Practice, and housing of research data in FDA-compliant databases with ability for electronic data transfer.
Case one: Helping a basic scientist make the clinical leap
Provide an infrastructure to help with protocol design, regulatory issues, and informed consent writing
Provide access to human subjects through a pool of research coordinators, where a subset of coordinators are nurse practitioners
Medical oversight by a Hospitalist and Center Directors
Study conduct oversight and monitoring by Clinical Research Support Office staff
Case 2: Help a research team go from concept to new drug
A team of basic scientists has discovered that targeting an antigen to dendritic cells as an antibody fusion protein (anti-DEC205+Antigen) is much more effective in inducing T-cell mediated immune responses. They want to use this technology to make a new vaccine for HIV, to be developed and tested in human subjects.
Help provided by our Center for Clinical and Translation Science
Help with submitting an IND to the FDA--provide advice about regulatory issues including product manufacturing, toxicity testing, stability testing, protocol design, and “pre-IND” discussions with FDA.
Help with conducting study under GCP, including design of case report forms, tracking of adverse events, creation of FDA compliant databases, and study monitoring. Access to study coordinators, data mangers, an IT infrastructure, and study monitors is provided within CCTS structure.
Deeper scientific resources for translational research
Our CCTS will establish a center for human immune monitoring. It will develop techniques and protocols to share with other CTS scientists and the scientific community at large
Our center has wide ranging studies in human immunology across many medical disciplines with need for standardized cell-based assays, most of which are likely to use advanced flow cytometric methodologies
The development of dendritic cell targeted vaccines also needs assay standardization to quantify T-cell responses to vaccine antigens and presence of specialized leukocyte subsets (e.g., mature dendritic cells).
Have inpatient and outpatient facilities that permit investigators to study human physiology or patients with defined diseases, with a staff attuned to special needs of human subject studies
Provide support for access to patients with rare diseases and study support at all levels (design, conduct, oversight and biostatistical analysis of studies), as well as outreach to patient communities with specific diseases
A training environment with mentors and graduate courses
A center accessible to graduate (PhD) students, medical students, post-docs, medical residents and fellows and allied health professionals, including research nurses to learn about or engage in translational science
Formal program for Master’s or PhD in Translational Science
Metrics to Measure Outcomes Evaluation of Clinical and Translational Research Improved Health Creation of New Therapeutics, Diagnostics, or Preventive Strategies Identification and Initial Validation of Therapeutic, Diagnostic, or Preventive Targets Scientific Discovery Therapeutics: Phase III Human Studies FDA Approval Clinical Practice Guidelines Diagnostics: FDA Approval Preventive Strategy:Clinical Practice Guidelines Phase I and II Human Studies Patents Issued Licenses Patent Application Invention Disclosures Mechanistic and Genetic Studies in Humans Positive Whole Animal Proof of Concept Studies Improved Understanding of Pathophysiology of Disease or Biologic Processes Inclusion of Concepts in Review Articles and Textbooks Invitation to Speak at Important Meetings Peer Honors Number of Published Papers Quality (Impact Factors) of Journals Peer-Reviewed Grant Support Indicators
New Master’s (degree granting) program now open for application; first K-12 supported students begin in 2007
New translational graduate course started and open to PhD candidates as of Jan 2007 and will continue/expand going forward
Actively building research coordination, GCP infrastructure, IT infrastructure, enhanced statistical support, and regulatory support elements now. Expect operational (interdependent) functionality within 1 year.
We want to collaborate with as many CTS centers as possible across all functions of clinical and translational science.
Collaboration should be stressed within educational opportunities
We have an active plan for development and distribution of unique biostatistical and informatics tools. New tools already developed for biomedical statistics are accessible and can be used via a web interface/grid computing network maintained by our Center.