Modification of RFA-CA-10-007 to Increase Applicants’ Flexibility for Proposing the Number of Clinical Trials to be Accomplished in the Funding Period

Notice Number: NOT-CA-10-016

Key Dates
Release Date: February 1, 2010

Issued by
National Cancer Institute (NCI) (http://www.nci.nih.gov)

Purpose

The purpose of this Notice is to modify the recently published Request for Applications, RFA-CA-07-009, entitled “Cancer Immunotherapy Trials Network (U01).” to increase applicants’ flexibility for proposing the number of clinical trials to be accomplished in the funding period.

SPECIFIC CHANGES IN THE TEXT OF RFA-CA-10-007 ARE AS FOLLOWS:

1. In Section I. Research Objectives, the fragment that reads:

“Overall Goals. The network is expected to initiate at least 15 Phase I or early Phase II trials over the course of the funding period”

is modified to read:

“The network is expected to initiate a number of high quality Phase I and Phase II trials over the course of the funding period”

2. In Section I. Research Objectives, the fragment that reads:

“Specific Benchmarks for the CITN, number 1. The number of Phase I and Phase II clinical trials initiated and completed. It is expected that three to four trials per year will be initiated after a 1-year ramp-up period, or a total of 15-20 trials in the total funding period, and at least half of these will be completed during this time.

is modified to read:

“The number of Phase I and Phase II clinical trials initiated and completed relative to the number of trials proposed.  It is estimated that up to 20 trials will be initiated. However, it is left to the applicant to decide on the specific number of trials to be initiated and completed by the network in the time frame and overall budget of the CITN”. 

With this modification, applicants may propose any number of trials that they feel can be initiated and completed in the total funding period, based on the budget allowed.

All other aspects of RFA-CA-09-012 remain unchanged.  Note, there will be no change in the budget related to allocation between CTSU and COSC components irrespective of the number of clinical trials applicants propose.

Note: A teleconference question and answer session between CTEP/DCTD and potential applicants will be held short to answer any questions related to this change or address other questions.  Issues discussed on the teleconference will also be posted on the CITN FAQs section of the CTEP/NCI website (http://ctep.info.nih.gov/highlights/200908_citn_rfa.htm).

Inquiries

Dr. William Merritt
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard EPN Room 7014, MSC 7436
Bethesda, MD 20892-7436 (for U.S. Postal Service)
Rockville, MD 20852 (for non-USPS deliver) Telephone: (301) 496-8866
FAX: (301) 480-4663
Email: merrittw@mail.nih.gov


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