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: https://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 https://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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