ADDENDUM - EARLY CLINICAL TRIALS OF NEW ANTI-CANCER AGENTS WITH PHASE I 
EMPHASIS (RFA-CA-02-011)

Release Date:  February 4, 2002

NOTICE:  NOT-CA-02-016

National Cancer Institute

This addendum is to inform potential applicants of a change in the 
APPLICATION PROCEDURES under Request for Applications (RFA), CA-02-011.  The 
change is as follows:

APPLICATION PROCEDURES

ALL Applicants

Item 2.a.is revised to read:

1.  Investigators should include in the appendix of the cooperative 
agreement application copies of 1-2 protocols which have been either 
been approved or activated recently and should identify particular 
areas of laboratory expertise that would be utilized in the performance 
of these trials.  If the applicant believes that complete drafts of 1-2 
potential protocols would better demonstrate their capabilities, these 
may be included rather than recently activated protocols.  The appendix 
protocol draft(s) is (are) intended to demonstrate the applicant's 
approach to incorporating relevant translational expertise to a 
specific, hypothesis driven clinical dose finding trial.  The 
protocol(s) should demonstrate the applicant's ability to 1) select a 
significant hypothesis, 2) describe the reasons for selecting a 
particular agent, study design, patient population and specific 
correlative studies, 3) provide a clear description of how the 
resulting data will be analyzed, 4) provide a description of the known 
or anticipated performance characteristics of the correlative 
methodology (how much variability is there in the method, how much 
change is expected across the dosing range, what is the maximal effect 
anticipated, etc?) and a detailed description of how correlative 
studies will be performed (a brief summary with reference to published 
methods is acceptable, but include a copy of the specific reference in 
the appendix).

This appendix of demonstration protocol(s) may or may not actually 
become part of the NCI portfolio under the cooperative agreement.  
Approved or recently activated protocols may demonstrate that the 
applicant have actually completed the intellectual and feasibility 
processes necessary to pursuing an early clinical trial.  If proposing 
a new protocol, the applicant should be aware that they may be making 
an effort that may not result in a clinical trial even if they compete 
successfully for an award.  Furthermore, if proposing a new protocol, 
the applicant should discuss issues that might hinder the feasibility 
of the protocol and how these issues would be addressed such as: 
availability of the agent, willingness of sponsor to permit evaluation 
of more than one IND agent, ethical issues that an IRB might raise, 
etc.   The applicant should also be aware that the appendix protocol(s) 
is/are expected to be completed protocol(s) that is/are ready to 
proceed, not early drafts. Proposing a protocol with an agent for which 
CTEP does not have a current IND is acceptable if the applicant 
believes that they have identified an agent early in development that 
might better showcase their capabilities.  However, in that case, the 
applicant must be sure they have obtained permission to incorporate 
suitable background material (obtained under confidentiality) from the 
agent's originator to permit reviewers to evaluate the proposed 
protocol.  Since demonstration protocols will not necessarily be 
undertaken, even by successful applicants, it is not necessary to have 
IRB review for these protocol(s).

All other provisions of CA-02-011 remain unchanged.  The complete RFA 
can be accessed at the following URL:  
http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-02-011.html.  Also 
please note that the revised application receipt date is March 28, 
2002.  See Notice NOT-CA-02-015 
http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-015.html.

INQUIRIES

Inquiries regarding this notice may be directed to:

Dr. Louise B. Grochow
Chief, Investigational Drug Branch
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Executive Plaza North, Room 7131
6130 Executive Blvd MSC 7426
Bethesda, MD  20892-7432
Telephone:  (301) 496-1196
Fax:  (301) 402-0428
E-mail:  grochowl@ctep.nci.nih.gov
L82S@nih.gov


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