Developing a National Registry of Pharmacologic and Biologic Clinical Trials Workshop Report (2006) / Chapter Skim
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Appendix C Sec. 113 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry: Information Programs on Clinical Trials...
Appendix C Sec. 113 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry: Information Programs on Clinical Trials...
Pages 63-80
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(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or lifethreatening diseases and conditions (in this subsection referred to as the `data bank')
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of the Federal Food, Drug, and Cosmetic Act, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, and a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public.
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of the Public Health Service Act; (B) on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations is required to be publicly disclosed; and (C)
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66 DEVELOPING A NATIONAL REGISTRY Guidance for Industry: Information Program on Clinical Trials for Serious or Life Threatening Diseases and Conditions Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration, 5600 Fishers Lane Rockville, MD 20857, (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm Or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, http://www.fda.gov/cber/guidelines.htm.
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F Which trials are provided to the public through the Clinical Trials Data Bank?
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I Can I submit other information to the Clinical Trials Data Bank?
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. It directs the Secretary of Health and Human Services, acting through the Director of NIH, to establish, maintain, and operate a data bank of information on clinical trials for drugs to treat serious or life-threatening diseases and conditions.
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, through its National Library of Medicine (NLM) and with input from the FDA and others, developed the Clinical Trials Data Bank.
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REQUIREMENTS UNDER SECTION 113 OF THE MODERNIZATION ACT FOR IND SPONSORS A What information must I submit to the Clinical Trials Data Bank?
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Location and Contact Information Location of Trial Contact Information (includes an option to list a central contact person for all trial sites)
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To provide a transitional period for sponsors of clinical trials that are currently ongoing and expected to continue enrolling patients for more than 45 days, we ask that you submit information within 45 days after this guidance is made available through the Federal Register. We encourage you to submit information through the PRS for inclusion in the data bank as soon as possible.6 C
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74 DEVELOPING A NATIONAL REGISTRY D What is a trial for a serious or life-threatening disease or condition?
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In addition, section 113 of the Modernization Act states that information on all treatment IND protocols and all Group C protocols10 must be included in the Clinical Trials Data Bank. Although it is not specifically discussed in section 113 of the Modernization Act, there are situations in which there may be a significant number of patients with the disease or condition for which the drug is being developed who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study.
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If the protocol meets these criteria, the sponsor must submit information about the trial to the Clinical Trials Data Bank, unless the sponsor provides detailed certification to FDA that such a disclosure would substantially interfere with the timely enrollment of subjects in the investigation (42 U.S.C.
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NLM intends to maintain the Data Bank as a long-term registry of clinical trials. Therefore, in addition to information about open trials, information about closed trials will also be available through ClinicalTrials.gov, even after accrual and analysis are completed and the product is approved.
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I Can I submit other information to the Clinical Trials Data Bank?
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Data from the current AIDS Clinical Trials Information System (ACTIS) and Physician's Data Query (PDQ)
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11The 1998 update of Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators provides guidance on IRB review and approval of listings of clinical trials on the Internet. See http://www.fda.gov/oc/ohrt/irbs/toc4.html#recruiting.
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