Conducting Clinical Trials

Information for Investigators

• Cancer Therapy Evaluation Program Investigator's Handbook

  Manual for investigators participating in clinical trials of investigational agents sponsored by NCI's Cancer Therapy Evaluation Program in the Division of Cancer Treatment and Diagnosis.

• Division of Cancer Prevention Clinical Trials Management

  Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

• Industry Collaborations

  Provides information regarding the process for co-developing an investigational anticancer agent with the NCI.

• What NIH Grantees Need to Know About ClinicalTrials.gov and FDAAA

  Information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements) to understand their roles and responsibilities in relation to ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007.

Tools for Managing Clinical Trials

• Protocol Development

  Guidelines and tools for protocol development, from the Cancer Therapy Evaluation Program (CTEP).

• Central Institutional Review Board Initiative

  Provides an innovative approach to human subject protection through a "facilitated review" process that can streamline local IRB reviews of adult and pediatric national multicenter cancer treatment trials.

• AccrualNet

  Website designed for practicing professionals to support clinical trial accrual needs.

• Cancer Trials Support Unit (CTSU)

  Project sponsored by NCI for the support of a national network of physicians to participate in NCI-sponsored cancer clinical trials.

Tools for Registration and Reporting

• Clinical Trials Reporting Program

  A comprehensive database of all NCI-supported clinical trials. The database exists to identify gaps in clinical research and duplicative studies. CTRP helps prioritize and enhance patient accrual to trials by making physicians aware of relevant opportunities for participation in clinical trials.

• Common Terminology Criteria for Adverse Events (CTCAE)

  Resources for standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.

• Cancer Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS)

  NCI's web-based system for submitting expedited reports for serious and/or unexpected events forwarded to designated recipients and the NCI for all trials using NCI-sponsored investigational agents.