title: The radioactive drug research committee: Background and retrospective study of reported research data (1975-2004).
abstract: In the United States, human research involving radioactive drugs must be conducted under a Food and Drug Administration (FDA) investigational new drug (IND) application, unless specifically exempt from IND requirements, or under the direct oversight of a Radioactive Drug Research Committee (RDRC) as long as certain conditions are met. Research overseen by RDRCs is considered basic science research when its purpose is to advance scientific knowledge and not to determine a radioactive drug's safety and effectiveness as a therapeutic, diagnostic, or preventive medical product in humans. We retrospectively reviewed and analyzed available study data from annual reports submitted to the FDA dating back to 1976. In 1976, there were 18 studies involving 531 subjects compared with 2003, when there were 284 RDRC studies involving 2,797 subjects. In 1976, RDRC subjects were imaged 5% of the time using positron-emitting nuclides and 77% of the time with conventional gamma-emitting nuclides. In 2003, this was reversed with 77% using positron emitters and 5% using conventional gamma-emitters. In 1976, pediatric studies comprised 7.3% of all RDRC subjects; today pediatric RDRC studies are rarely conducted. Today the RDRC is used primarily by large medical research institutions. Although the program has a very good safety record, RDRC's 30-y-old regulations need to be revised to be consistent with current scientific knowledge and health policy.
authors.affiliation: Office of Oncology Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA. Orhan.Suleiman@FDA.HHS.GOV
authors.forename: Orhan H
authors.initials: OH
authors.lastname: Suleiman
authors.forename: Richard
authors.initials: R
authors.lastname: Fejka
authors.forename: Florence
authors.initials: F
authors.lastname: Houn
authors.forename: Maria
authors.initials: M
authors.lastname: Walsh
mesh_terms: D035843:Biomedical Research / Q000592:standards; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004341:Drug Evaluation; D015507:Drugs, Investigational / Q000592:standards*; D006805:Human Experimentation; D006801:Humans; D010606:Pharmacy and Therapeutics Committee; D049268:Positron-Emission Tomography / Q000592:standards; D019275:Radiopharmaceuticals / Q000592:standards*; D011878:Radiotherapy / Q000592:standards*; D012189:Retrospective Studies; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational; D019275:Radiopharmaceuticals