The PCCTC is now accepting applications for its Affiliate Clinical Research Site program.

Key Dates

RFA Issue date: July 22, 2014

Application deadline: August 22, 2014

Expected membership notification date: September 26, 2014

Overview

Consisting of a network of physician-investigators at academic institutions, the Prostate Cancer Clinical Trials Consortium (PCCTC) is the nation’s leading multicenter clinical research organization specializing in cutting-edge prostate cancer research. Consortium members work together on a single mission: to design, implement and complete hypothesis-driven clinical trials, translating scientific discoveries to improved standards of care. The PCCTC’s Affiliate Clinical Research Site program welcomes qualified institutions to contribute and participate in Consortium trials. Funding supports infrastructure related to the conduct of PCCTC clinical trials. Additional unfunded Affiliate Research Sites may be selected.

Objectives

The objective of this RFA is to solicit applications for PCCTC Affiliate Clinical Research Site membership.

Affiliate Clinical Research Site participation is intended to enrich the Consortium’s research areas which include but are not limited to:

• Clinical development opportunities based on the strength of the underlying science, particularly the biologically-based translational science of its members. 

• Informative, sequential trial development with individual trials incorporating A) outcome measures corresponding to the unmet needs associated with the specific clinical state of the disease for which the drug is being tested and B) biomarkers tailored to the compound’s mechanism of action.

• Investigator-initiated trials that optimize dose, explore novel combinations, and lead to the discovery and validation of predictive biomarkers of sensitivity that can guide the use of an investigational product.

Performance Metrics

Exercise of the options for continued performance of each Affiliate Clinical Research Site after the first year will be contingent upon meeting the following performance metrics as specified in the Consortium Participant Agreement:

• Accrue ≥ 25 patients per year

• Enroll ≥ 5% of patients from disproportionately affected populations (or an agreed upon percentage commensurate with a site’s local population)

• Participate in ≥ 6 trials initiated by other sites over 3 years

• Propose ≥ 2 trials per year or 6 trials over 3 years

• Timely submission of quality data as outlined by the Coordinating Center

Funds Available

Applications at one funding level will be considered: $100,000 per year (direct costs only) for a total of three years. Funds for the Affiliate Clinical Research Sites may cover:

• Administrative support including salary

• Consortium meetings and related travel among participating investigators

• Teleconferences

• Other costs directly associated with planning and developing PCCTC research.

An institution may be eligible for unfunded affiliate status if it was not selected for funding via the process established for the Affiliate Clinical Research Sites (see Award Administration).

Key Criteria

• Innovation. A clinical research portfolio characterized by innovative translational trials with the potential to transform the understanding of prostate cancer, and ultimately diagnosis, prevention, or treatment of the disease.

• Relevance. Demonstrated commitment to the PCCTC’s research areas.

• Collaboration. The ability and capacity to participate in collaborative multicenter clinical research.

• Scientific Excellence. Overall scientific merit as determined by peer review.

Eligibility

• National Cancer Institute (NCI) Cancer Center designation or equivalency for non-US sites.

• Eligible to participate in research programs and grants provided by the National Institutes of Health (NIH).

• Site investigators must possess valid and unrestricted licenses to practice medicine pursuant to the laws of the state in which they reside.

• Institution or investigator cannot have been disciplined at any time by the Department of Health or medical licensing board of any state or convicted of any state or federal crime.

• Possession of valid state and federal narcotics numbers.

Application

Applicants must use the PCCTC Affiliate Clinical Research Site application template which is available at the following link:

PCCTC Affiliate Site Application

Completed applications along with a four-page NIH Biographical Sketch and Other Support page should be submitted as Word or PDF documents to simmona1@mskcc.org. Appendices are not allowed.

Review Mechanism

Applications will be reviewed by a Scientific Oversight Committee (SOC) made up of peers from participating PCCTC institutions. Applications will be scored with respect to the Key Criteria, described above, with particular emphasis on the potential for increasing the breadth and depth of PCCTC activities with attention to unique populations or resources. The SOC will provide recommendations to the PCCTC Executive Committee. The Executive Committee will make all final funding decisions. There will be one deadline for application to this RFA.

Award Administration

Funding decisions will be provided to applicants. Selected Affiliate Clinical Research Sites will execute a Consortium Participant Agreement with the PCCTC upon notice of successful award. This will be a requirement to fully participate in the Consortium. The PCCTC will provide funding to the two sites selected in accordance with this process at $100,000 per year.

Awardees will be required to submit an annual progress report and financial statements to the SOC. Exercise of the options for continued performance for each Affiliate Clinical Research Site after the first year will be contingent upon meeting performance metrics as specified in the Consortium Participant Agreement (see Performance Metrics).

Additional Unfunded Affiliate Clinical Research Sites are subject to approval by the SOC and may be limited in their participation as appropriate. Unfunded Affiliate Clinical Research Sites will be required to execute a Consortium Participant Agreement with the PCCTC.

Further Information

Any questions concerning this RFA should be addressed to: 

Jake Vinson

PCCTC, LLC

Email: vinsonj@mskcc.org

By : admin