EARLY PHASE CLINICAL RESEARCH SUPPORT (EPCRS)*
This CCSG component provides support for short term, pilot (pre-phase I) and phase I clinical
research studies originating from scientific investigators within the cancer center (See
definitions). Preliminary data generated from these studies, which historically have been rarely
funded through other mechanisms, can be used as the basis for application for support of later phase
studies through competitive grants or industry. Support is not meant for all early phase trials, for later
phase trials, or for studies that do that do not involve testing of an agent or device.
These funds may be used for global health studies, but must meet all eligibility criteria listed below.
In addition, NIH must track all projects in this category that include foreign components and, if
necessary, State Department clearance must be obtained prior to implementation. OCC staff will act
as the liaison between the Centers and the NIH Fogarty International Center, which is responsible for
coordinating all clearances.
Eligibility criteria are as follows:
These should be high priority, innovative, pilot and phase 0 or I institutional clinical studies focusing on initial early phase testing of a candidate agent or device for the diagnosis, prevention detection or treatment of cancer.
Studies must be conceptualized/designed by members of the center’s research Programs.
Studies should typically be of short duration (e.g., 1-2 years).
Studies receiving support through other peer-reviewed research grants, cooperative agreements, or contracts are ineligible for support through this mechanism. Studies may receive partial support from industry, assuming all other criteria are met.
The center’s PRMS must be approved or conditionally approved by peer review for funding of studies supported through this component.
Supported studies must be approved by the PRMS.
Funding in these pilot and phase I clinical studies is limited to support of:
Nurses and data managers for a pilot (pre-phase I) or phase I clinical trial,
Costs associated with generation of preliminary data through other early phase clinically related activities, for example:
Purchase of imaging time for scans related to early phase clinical research
Support for IND or IDE applications
Pharmacodynamic studies, e.g., use of sequential or pre- and post- biopsies or assays of activity in peripheral tissues to identify investigational agents deserving full clinical development, clinical evaluation of structurally similar analogues directed at the same molecular target, determination of a dosing regimen for an agent to be used in combination therapy, or development of novel imaging probes that establish mechanism of action in patient samples or provide functional and metabolic information about the effect of a drug on its target.