Title:
Quick-Trials for Novel Cancer Therapies: Exploratory Grants (R21) (reissued PA)

Contact:

Roy Wu, Ph.D.;
Heng Xie M.D., Ph.D.; M.P.H.,
Steven Krosnick, M.D.,
LeeAnn Jensen, Ph.D.
Clinical Grants and Contracts Branch
Cancer Therapy Evaluation Program
DCTD, NCI
Telephone: (301) 496-8866
E-mail: wur@mail.nih.gov xiehe@mail.nih.gov krosnics@mail.nih.gov jensenl@mail.nih.gov

Objective of Project:

The Quick‑Trial program announcement is designed to accelerate the translation of promising relevant advances in novel cancer treatment/prevention approaches from the laboratory into the clinical setting. Advances in the understanding of molecular cancer genetics, basic cancer biology, and the development of powerful technologies (e.g. microarrays, proteomics, bioinformatics, and nanoparticles) have led to the identification of many new molecular targets and pathways in cancer cells. These novel targets and pathways present excellent translational research opportunities for improving early cancer diagnosis and treatment, and developing more effective and targeted molecular therapies and prevention strategies in clinical practice. The translation of such strategies to clinical evaluation is complex and resource intensive. The objective of this program announcement is to provide investigators with accelerated access to funding for early phase cancer clinical trials and associated patient monitoring and laboratory studies. Phase III trials are not excluded but such trials generally require greater resources and duration than available from an R21 award.

Description of Project:

This Quick‑Trial program announcement will seek R21 applications limited to cancer clinical trials, as well as patient monitoring and laboratory studies directly associated with such clinical trials. The focus is on early stage cancer clinical trials. This is in keeping with the budget and duration limits associated with R21 applications. While R21 applications have no prerequisite for extensive preliminary data, applicants are expected to adequately justify the participation of human subjects. Features of the Quick-Trials program include a modular budget, inclusion of the clinical protocol within the grant application, and accelerated peer-review with the goal of issuing new awards within six months of receipt of the application. In addition to requiring the inclusion of a clinical protocol in the application, the program announcement will emphasize the required components of a clinical application.