Notice ID
a398bf3bd5f3957faad05ff6f1a1658c
The Cancer Therapy Evaluation Program CTEP Division of Cancer Treatment and Diagnosis DCTD National Cancer Institute NCI is responsible for administration and coordination of most of the extramural clinical trials supported by the DCTD It is also responsible for the ongoing clinical development of more than 100 agents on which the Division has filed more than 150 Investigational New Drug Applications INDs with the Food and Drug Administration FDA The CTEP must prepare file and manage INDs for the investigational agents it sponsors in clinical trials including the agents from the NCIs intramural clinical programs As the sponsor of these agents DCTD must design a plan for the efficient evaluation and development of these agents and monitor the safety efficacy and drug distribution of the agents in the trials tracking the progress of the studies both administratively and scientifically review and transmit adverse events in a timely manner and preparing IND annual reports for submission to the Food and Drug Administration FDA investigator brochures for agents and other special reports and manuscripts The CTEP must also submit amendments to the INDs it sponsors including new protocols protocol amendments adverse events updated chemistry and manufacturing information compassionate exemptions and responses to FDA communications At least annually federal law requires that an IND sponsor analyze and summarize all results from the investigational agents development in an Annual Report submitted to the FDA on the anniversary of the IND filing These results are reported to the CTEP by quarterly and annual data updates Clinical Data Update System CDUS biweekly by the Clinical Trials Monitoring System by publications Cooperative Group reports and periodic meetings with clinical investigators Annual Reports are reviewed and used by the Program Medical Staff who develop future plans for the agent IND sponsors have the obligation to inform investigators the Office of Biotechnology Activities OBA NIH for gene transfer studies and the FDA of any serious or unexpected Adverse Events AEs that have been observed When AE reports are made to the CTEP Program staff analyze and categorize them according to severity The Contractor shall provide support to the CTEP Investigational Drug Branch IDB and Regulatory Affairs Branch RAB for a wide range of services related to these responsibilities These services include assistance with Investigational New Drug Applications INDs investigational agent development and clinical research information management assessment of adverse events logistical and clerical support It is anticipated that one award will be made and that the resulting contract will be awarded on an incrementally funded basis for a period of 6 years The Governments requirement is 67000 hours per year for a total of 405600 total hours over the 6 years RFP N02CM2702232 will be available on or about 101501 with a due date for receipt of 111601 For further information the Request Proposals will be available on the NCI Research Contracts Branch web site at httprcbinterncinihgovapplrfprfpspublishedjsp on or about 101501
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