PHASE II TRIALS OF NEW ANTI-CANCER AGENTS NIH Guide, Volume 22, Number 14, April 9, 1993 RFA: CA-93-009 P.T. 34 Keywords: Clinical Trial Cancer/Carcinogenesis Chemotherapeutic Agents Pharmacology National Cancer Institute Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: June 10, 1993 The Division of Cancer Treatment of the National Cancer Institute (NCI) would like to clarify Request for Applications (RFA) CA-93-09, published in the NIH Guide, Vol. 22, No. 5, February 5, 1993 as follows: The section entitled SPECIAL REQUIREMENTS is modified as follows: 2. The applicant must demonstrate in the application the ability to meet the following requirements: a. documented numbers of eligible patients with a history of adequate accrual to complete on average two to three Phase II trials annually. 1) information should be provided on the numbers of eligible patients in each disease category, particularly in, but not limited to, tumors of special interest such as breast, ovarian, lung and urologic cancers, that would be available for inclusion in Phase II clinical trials. 2) it is desirable for applications to indicate the relative emphasis of the proposed projects to each of these disease categories. The section entitled AWARD CRITERIA is modified as follows: AWARD CRITERIA The anticipated date of award is June 10, 1994. In addition to the technical merit of the application, NCI will consider how well the applicant institution met the goals and objectives of the program as described in the RFA, availability of resources, and balance of study populations. While applications may include any malignancy, it should be noted that those applications that involve anti-cancer agents particularly relevant to breast cancer and the ability to conduct Phase II trials in breast cancer will be given a high priority for funding should additional dedicated funds become available for this purpose. .
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