Managing oncology research protocols.
Oncology research protocol management is important for the effective execution of clinical trials with oncology patients. Clinical trials explore investigational drug safety, efficacy, and effectiveness. Investigational drugs have not received approval for widespread use and marketing by the Food and Drug Administration (FDA). The National Cancer Institute (NCI) has several branches concerned with investigational drug procurement, distribution, and recordkeeping of investigational cancer chemotherapy agents. Before an investigational drug is approved by the FDA for marketing in the United States, it must undergo several phases of pre-clinical and clinical trials. The Institutional Review Board (IRB) must review and approve clinical trials to ensure that studies meet legal, ethical, and scientific standards. The principal investigator (PI) takes responsibility for the clinical trial. Informed consent must be obtained from subjects before they may participate in clinical trials. The informed consent form is reviewed by the IRB. The investigational drug storage, accountability, ordering, distribution, and drug information dissemination process is improved with a pharmacy-coordinated investigational drug service.
Lunik
M C
MC
Saint Louis University Hospital, MO.
D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval / Q000458:organization & administration*; D004346:Drug Information Services; D004356:Drug Storage; D015507:Drugs, Investigational / Q000592:standards*; D005568:Forms and Records Control; D006801:Humans; D007258:Informed Consent; D009369:Neoplasms / Q000188:drug therapy*; D010607:Pharmacy Service, Hospital / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration