The ClinicalTrials Tool Kit CTK

1
The ClinicalTrials Tool Kit (CTK)

• A Proposed Public-Private Partnership to Support
• NIH Intramural Programs,
• Research Universities, and
• Non-Profit Health Organizations

2
The ClinicalTrials Tool Kit (CTK) is a collection
of software tools and research services in use
within the NIH Intramural Program

• The objective of the CTK project is to advance
  medical research support
• Improve clinical IT systems and data management
• Facilitate research collaborations
• Increase the cost efficiency of research programs
• The project utilizes a set of tools and services
  to achieve these objectives
• Clinical Trials Database (CTDB)
• A web-based application used to organize clinical
  research projects, and collect patient response
  data.
• Clinical Datamart (CDM)
• A reporting process and structure that
  centralizes clinical data for investigators.
• Clinical Wiki (cWiki)
• A web-based collaborative tool that allows
  investigators to work together on research
  projects
• Core Research Services
• A support team of nurses, doctors, and research
  assistants that assist investigators implement
  their protocols and utilize the clinical software
  applications
• Custom Research Services
• Staff assistance for investigators with protocol
  needs beyond those offered through core services

3
The CTK project currently supports approximately
100 NIH protocols

• Eunice Kennedy Shriver National Institute of
  Child Health and Human Development (NICHD)
• National Institute of Dental and Craniofacial
  Research (NIDCR)
• National Institute of Nursing Research (NINR)
• National Institute of Diabetes and Digestive and
  Kidney Diseases (NIDDK)
• National Institute of Arthritis and
  Musculoskeletal and Skin Diseases (NIAMS)
• NIMH (Trial Usage)
• University of Maryland
• George Washington University
• Baylor Medical College (TX)
• Childrens Hospital (Oakland, CA)
• University of North Carolina (planned)
• University of Chicago (planned)

• The flexibility of the software accommodates a
  wide range of protocol study designs natural
  history, screening, treatment, and controlled
  clinical.
• CTK supports the key processes for clinical
  trials management protocol design, data
  collection, and reporting
• The project has assisted investigators with over
  200 publications (journal articles, abstracts,
  posters)

4
The CTK will stimulate Intramural research
collaboration with universities, hospitals,
non-profit organizations and patients.

• The Clinical Wiki (cWiki) organizes protocols
  across multiple sites
• Support Trans-NIH initiatives that cross multiple
  Institutes
• Centralize protocol procedures and forms
• Location Independent
• Facilitates patient recruitment and the study of
  rare diseases
• Allows patients to join NIH Intramural protocols
  led in Bethesda, MD
• Communication Tools
• Provide group calendars
• Facilitate web forums, discussions
• Web-based Publication Tools
• Authoring publications
• Visualizing data

5
The CTK architecture and design leverages other
important NIH research initiatives and national
health care standards

• Architected with Industry Proven Technologies
• Federal Enterprise Architecture (Java, Oracle,
  Unix)
• UML, XML based design and development
• Standard reporting tools - Business Objects and
  Cognos
• Harmonization with other NIH projects
• CC CRIS and CRIS2 systems
• NIH Biorepository requirements
• NIH Roadmap - PROMIS (Patient Reported Outcome
  Measures)
• NCI Cancer Bioinformatics Grid (caBIG) Bronze
  Level projected
• NLM dbGaP database for Genome Wide Association
  Studies
• Utilizes Standard Medical Nomenclatures
• SNOMED for clinical observations
• LOINC for laboratory test methods and values
• HL7 capability (if required)

6
The goal of the public-private partnership is to
further develop the CTK into a package available
to the broader medical research community

• The CTK will allow Universities with limited
  infrastructure to leverage NIH resources.
• Reduces the cost of IT labor and hardware
  investments
• Provides tools for professors with limited grants
• Improves services for the Investigator. Key time
  periods during a protocol often require a
  Threshold of resources not typically available.
• Supports the continuity of research for
  investigators with multiple students during the
  study
• Creates opportunity for medical residents and
  students No staff support required
• After the initial protocol, CTK users find
  subsequent protocols easier to design and manage.
• The CTK promotes Grass-Roots initiatives
  conducted by non-profit organizations
• Provides the ability to conduct large-scale
  studies in a cost effective manner
• Delivers a collaborative platform for researchers
  often conducting similar research projects
• Establishes an inclusive research environment
  that facilitates patient recruitment
• Overall, CTK support assists researchers advance
  science
• Develop new medical procedures (e.g., screening
  test)
• Discover novel therapeutics (e.g., vaccine, drug)
• Elucidate biological mechanisms (e.g., genetic
  markers) related to a clinical conditions.
• Provides tools to access data readily for
  statistical analysis
• Allows physicians to review patient records and
  summary data quickly