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Cancer Clinical Trials: A New National System
A Web gateway to the interlocking pieces of the new system

http://cancertrials.nci.nih.gov/system

Making trials more efficient, accessible, and open to innovation

A fundamental shift is underway in how NCI develops, reviews, conducts, and supports clinical trials. The new system will speed new treatment ideas from laboratory to clinic, increase physician and patient participation, and streamline administration and data reporting.

Why revamp?

Recent rapid advances in biomedicine and trends in health care are challenging the clinical research establishment to make trials more efficient, accessible, and open to innovation.

To address these challenges, NCI formed a Cancer Clinical Trials Review Group with 30 experts from outside the Institute. The Group made nearly four dozen recommendations for change.

Those recommendations were turned into an action plan by a Clinical Trials Implementation Group and that plan is now being implemented. The new system has numerous components, which fall into five main categories:

• Generating New Ideas
• Broadening Access for Physicians and Patients
• Educating and Communicating
• Streamlining Procedures
• Automating Data Systems

Generating New Ideas

• State-of-the-Science Meetings
  To stimulate ideas for multi-center (phase III) trials, these meetings include clinical and basic scientists from academia and industry, patient advocates, and other cancer care professionals.
  http://www.webtie.org/sots/sots.htm
  
• Concept Evaluation Panels
  Including members of the Cooperative Clinical Trials Groups, NCI, non-Group investigators, and patient advocates, these disease-specific panels are being piloted in lung and genitourinary cancers. Panels meet monthly to review concepts for phase III trials.
  http://www.webtie.org/
  
• Rapid Access to Intervention Development (RAID)
  RAID provides funds and expertise to help investigators take promising new discoveries into clinical trials.
  http://dtp.nci.nih.gov/docs/raid982.html#raidef
  
• Clinical Oncology Special Emphasis Panel (SEP)
  SEP provides the clinical oncology community with its own study section at the National Institutes of Health.
  http://www.drg.nih.gov/review/clinonc.htm
  
• Correlative Science Studies
  Additional NCI funding has been allocated to support investigations that explore the relationship between tumor characteristics and clinical outcomes.
  http://www-cdp.ims.nci.nih.gov/new.html

Broadening Access for Physicians and Patients

• Expanded Participation Project
  This pilot project extends access to NCI-sponsored trials to qualified community oncologists.
  http://light.emmes.com/epp
  
• National Network of Physician Partners
  When operational, the Network will enable qualified physicians in academic and community settings to enter patients on phase III trials.
  
• Special Populations Networks for Cancer Awareness Research and Training (SPN)
  The SPN will foster cancer awareness, including support for minority enrollment in trials.
  http://ospr.nci.nih.gov/networks.html
  
• Physician Communication Module
  NCI's Cancer Therapy Evaluation Program (CTEP) and Howard University Cancer Center (HUCC) are working on a collaborative effort to develop and apply electronic technology to increase the participation of HUCC physicians in clinical trials.

Educating and Communicating

• cancerTrials
  This Web site serves as NCI's online gateway to clinical trials resources.
  http://cancertrials.nci.nih.gov
  
• CancerNet
  Another NCI Web site, this one is home to NCI's searchable clinical trials database and includes peer-reviewed, state of the art summaries on specific cancers.
  http://cancernet.nci.nih.gov
  
• Cancer Information Service
  NCI's 1-800-4-CANCER line continues to provide current, accurate information to the public, including information on clinical trials.
  http://cis.nci.nih.gov/
  
• Education Programs
  Through training modules and partnerships with professional and health plan organizations, NCI is working to inform health professionals and cancer advocates about clinical trials.
  E-mail: cancertrials-r@mail.nih.gov.
  
• New Training Grants
  Additional training funds support the development of new and established clinical investigators.
  http://cancertraining.nci.nih.gov
  
• Forming Partnerships
  Collaborations with advocacy groups, industry, and health plans are aimed at widening participation in clinical trials. The Director's Consumer Liaison Group (http://deainfo.nci.nih.gov/ADVISORY/dclg/dclg.htm) is one example.

Streamlining Procedures

• Cancer Trials Support Unit (CTSU)
  Designed to centralize and streamline many administrative, financial, and data collection tasks, the CTSU provides participating physicians with a single access point to NCI's entire phase III clinical trials system.
  http://www.ctsu.org
  
• Informed Consent
  New recommendations for informed consent documents aim to make the forms more understandable and more useful.
  http://cancertrials.nci.nih.gov/researchers/safeguards/consent/index.html
  
• Central Institutional Review Board (IRB)
  A pilot project will determine whether a central IRB can reduce the burden on local IRBs and serve as a model for the protection of patients.
  
• Protocol Assembly
  A series of electronic forms, templates, and databases make it easier for investigators to submit and develop ideas for protocols.
  http://ctep.info.nih.gov/InfoForms/default.htm
  
• Clinical Trials Monitoring Branch Auditing Information System
  This Web-based system permits online collection of audit data and tracking of audit findings.

Automating Data Systems

• Common Toxicity Criteria (CTC)
  Revised in 1 998, the CTC provides a standard language for reporting adverse events occurring in cancer trials.
  http://ctep.info.nih.gov/CTC3/default.htm
  
• Adverse Event Expedited Reporting System (AdEERS)
  This Web-based system allows investigators to submit Expedited Reports online.
  http://ctep.info.nih.gov/AdEERS/default.htm
  
• Clinical Data Update System
  This automated system has become the primary data reporting mechanism for all NCI-sponsored trials.
  http://ctep.info.nih.gov/Cteplnformatics/CDUS/Default.htm
  
• Common Data Elements (CDE)
  The CDE Dictionary promotes a common nomenclature and vocabulary enabling the collection and reporting of research data
  for clinical trials.
  http://cii.nci.nih.gov/cde

For more information, visit NCI's Web site for clinical trials
http://cancertrials.nci.nih.gov

NATIONAL INSTITUTES OF HEALTH
National Cancer Institute
NIH Publication No. 00-4792
May 2000
T591

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