Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI Table of Contents Part A 1 2 3 Part B 4 5 6 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices

Part A: Sponsors, Research Bases, and the Investigator

1. Introduction

When investigators perform clinical trials, two organizations are crucial--the sponsor of the trial and the research base. The next two sections discuss the purposes and features of each. In particular, we describe the role of the DCTD as a sponsor of investigational agent trials; as a sponsor DCTD is responsible for the overall direction of the process of new agent development as well as its practical implementation. Of course, DCTD is not the only sponsor of trials involving new anticancer agents. The activity of private pharmaceutical companies has increased dramatically in recent years. We outline here the basis of the relationship among DCTD, pharmaceutical companies, and investigators supported by DCTD in the conduct of clinical trials. We also discuss the vital role of the research base in support of the investigator. As is the case with all types of research, clinical trials cannot take place without a substantial institutional commitment.

2. The Sponsor

• 2.1. How NCI Funds Research
• 2.2. Preclinical Development of New Agents
• 2.3. Collaboration Between Sponsors: DCTD and the Pharmaceutical Companies
• 2.4. Private Support of Trials Sponsored and Funded by NCI
• 2.5. Private Support of Trials Sponsored but Not Funded by NCI
• 2.6. The Investigational New Drug Application (IND)
• 2.7. The Marketing Application

3. The Research Base and the Investigator

• 3.1. Definition and Purpose of a Research Base for Clinical Trials
• 3.2. Activities of the Research Base
  • 3.2.1 Protocol Development
    • 3.2.1.1. Scientific Review
    • 3.2.1.2. Biostatistical Consultation
  • 3.2.2 Protocol Administration
  • 3.2.3. Establishment of an Affiliate Program
  • 3.2.4. Agent Accountability and Storage
  • 3.2.5. Reporting of Results to CTEP
  • 3.2.6. Data Management and Statistics
  • 3.2.7. Quality Assurance

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