Lunik M C
Saint Louis University Hospital, MO.
Top Hosp Pharm Manage. 1994 Jul;14(2):11-21.
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.
肿瘤学研究方案管理对于有效开展针对肿瘤患者的临床试验至关重要。临床试验旨在探究研究性药物的安全性、有效性和效能。研究性药物尚未获得美国食品药品监督管理局（FDA）的广泛使用和上市批准。美国国立癌症研究所（NCI）有多个部门负责研究性癌症化疗药物的采购、分发和记录保存。在一种研究性药物获得FDA批准在美国上市之前，它必须经过几个阶段的临床前和临床试验。机构审查委员会（IRB）必须审查并批准临床试验，以确保研究符合法律、伦理和科学标准。主要研究者（PI）负责临床试验。在受试者参与临床试验之前，必须获得他们的知情同意。知情同意书由IRB进行审查。通过药房协调的研究性药物服务，可以改进研究性药物的储存、问责、订购、分发和药物信息传播流程。
