Contact:

Heng Xie, M.D., Ph.D.
Clinical Grants & Contracts Branch
CTEP/DCTD/NCI
Telephone: 301-496-8866
Fax: 301-480-4663
E-mails: xiehe@mail.nih.gov

Objective of Renewed PA:

The NCI is seeking R01 applications to conduct translational clinical therapeutic and preventive studies and trials of neoplastic diseases in humans, and encourages clinical researchers to collaborate with basic scientists to translate insights in cancer biology into innovative cancer intervention studies and trials. The overall aims of this renewed initiative are two-fold: (1) to stimulate development of innovative therapeutic and/or preventive clinical trials with or without laboratory correlative studies and (2) to support innovative correlative laboratory studies linked to therapeutic and/or preventive clinical trials. Investigators may address either aim in their applications.

Scope of Renewed PA:

This renewed initiative encompasses a full range of translational therapeutic and preventive studies and trials that employ single or combination modalities, such as drugs, biologics, herbal therapies, dietary supplements, bioactive food components, hypothermia/hyperthermia, radiation, unconventional pharmacological and biological interventions, and surgery. In addition, cancer molecular profiling and other biological correlative studies that have clinical relevance to therapeutic/preventive trials and aim at improving cancer treatment/prevention are also appropriate. Laboratory studies of the underlying mechanisms of intervention, the mechanisms of disease pathogenesis, or the identification of surrogate markers of disease activity and therapeutic effect are encouraged. Clinical correlative or laboratory studies using patient specimens from the clinical trial may include patient monitoring studies (i.e., pharmacokinetics, immune response, etc.), may guide clinical development of the new agent or approach, and may identify patient subsets for specific therapies. This initiative will provide investigators with support for new intervention studies/trials or a continuation of previous significant studies/trials derived from pilot, phase I/II clinical cancer therapeutic or prevention studies/trials. Clinical studies/trials must involve human subjects and be based on a strong rationale and preclinical or clinical data which support the underlying hypotheses. Applications may include single or multi-institutional studies/trials with appropriate biological correlates linked to these studies/trials. Statistical design issues should be addressed in the research plan for both the clinical protocol and the laboratory analyses.