Storage and Distribution of Clinical Agents

临床制剂的储存和分配

• 批准号: 8008846
• 负责人: YOUNG KIM
• 金额: $ 155.16万
• 依托单位: FISHER BIOSERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8008846
• 关键词: Biocompatible Materials; Blinded; Cancer Center; Cancer Therapy Evaluation Program; Clinic; Clinical; Clinical Distribution; Clinical Trials; Conduct Clinical Trials; Contractor; Contracts; Developmental Therapeutics Program; Division of Cancer Prevention; Double-Blind Method; Equipment and supply inventories; Guidelines; Human Resources; Individual; Institution; Label; Malignant Neoplasms; Manufacturer Name; Methods; Monitor; New Agents; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacologic Substance; Physicians; Placebos; Preclinical Drug Development; Printing; Process; Protocols documentation; Randomized; Randomized Clinical Trials; Rapid Access to Intervention Development; Records; Regulation; Research; Research Personnel; Research Support; Secure; Services; Shipping; Ships; Site; Specific qualifier value; Support Contracts; Temperature; Training; Visually Impaired Persons; anticancer research; cancer imaging; clinical research site; computerized; open label; prevent; programs; repository

The NCI Clinical Repository Contract, Storage and Distribution of Clinical Agents, is vital for the support of clinical cancer research trials using investigational agents. The contract supports open-label and double-blind cancer clinical trials sponsored by the Cancer Therapy Evaluation Program (CTEP), NCI. In addition, it provides support for double-blind, randomized clinical trials sponsored by the Division of Cancer Prevention, NCI; supports the Rapid Access to Intervention Development Program of the Developmental Therapeutics Program, NCI; supports clinical trials conducted by the Cancer Imaging Program, NCI; and supports clinical trials conducted by the NCI Cooperative Groups. This contract also supports preclinical drug development research of NCI grantees, academic institutions, Cooperative Groups, and Cancer Centers. Agent management services are used to support high-priority, scientifically important cancer clinical trials conducted by the NCI's Cooperative Groups using agents for which the NCI does not sponsor and where accrual would be significantly less or significantly slower without agent distribution. The contract also provides a compassionate distribution program that provides promising new agents to physicians whose patients could benefit. The Pharmaceutical Management Branch (PMB), CTEP, in providing pharmaceutical support for cancer clinical trials sponsored by the NCI, manages the contractor that provides an adequate facility and project team to store and distribute clinical agents and maintain adequate records of all aspects of the process. This contract provides for the receipt, storage, inventory control, distribution, and final disposition of hundreds of investigational agents used to treat or prevent cancer in support of NCI-sponsored or supported clinical trials. The Contractor receives and inspects agents from manufacturers and suppliers throughout the world. Agents are inventoried and stored in a secured, monitored, fire-protected warehouse under specified controlled temperature conditions. Computerized record keeping accompanies each step of the receipt, storage, distribution, and final disposition of each unit of agent. When a registered NCI investigator at a clinical trial site requires an agent supply for an NCI study, the clinical trial site submits an order called a Clinical Drug Request (CDR). This request, which speci¿fies the protocol, agent, strength and number of units needed, as well as other necessary information, is sent to PMB for approval. Upon approval, Shipping Records are printed at the repository, where the agents are packaged into shipping containers in such a way that the agents are delivered to the clinical sites intact under appropriate environmental conditions. All agents are shipped using validated shippers and methods. Shipments are made to investigators throughout the world. All personnel are trained in the handling, storage, shipping, and disposal of hazardous and biological materials. The contractor complies with the applicable guidelines and regulations of many Federal Agencies including, but not limited to, OSHA, EPA, DOT, IATA, and the Good Manufacturing Practices (GMP) of the FDA. In support of randomized, double-blind clinical trials, the Contractor provides storage, patient-specific blinded labeling, detailed record-keeping and distribution services to individual clinical sites. Approved requests for patient-specific shipments on double-blind clinic trials are received by the Contractor from PMB with patient-specific information and treatment assignment. Individual, blinded container labels are printed and checked, and the appropriate product (agent or placebo) pulled, labeled, and checked by a pharmacist before shipping to the investigator.

NCI临床存储库合同，临床药物的存储和分布对于使用研究剂支持临床癌症研究试验至关重要。该合同支持NCI癌症治疗评估计划（CTEP）赞助的开放标签和双盲癌临床试验。此外，它为预防癌症的分区NCI提供了双盲，随机临床试验的支持；支持NCI的开发治疗计划的快速访问干预开发计划；支持癌症成像计划NCI进行的临床试验；并支持NCI合作组进行的临床试验。该合同还支持NCI授予者，学术机构，合作团体和癌症中心的临床前药物开发研究。代理管理服务用于支持NCI合作组进行的高优先级，科学重要的癌症临床试验，使用NCI不赞助的代理，并且如果没有代理分布，则准确或准确的准确性将大大降低或明显较慢。该合同还提供了一个富有同情心的分销计划，该计划为患者可以受益的医生提供了有希望的新代理商。 CTEP的药物管理部门（PMB）在为NCI赞助的癌症临床试验提供药物支持时，管理了承包商，该试验提供了提供足够的设施和项目团队来存储和分发临床代理商并维持该过程各个方面的足够记录。该合同规定了数百名用于治疗或预防癌症的研究剂的收据，存储，库存控制，分配和最终处置，以支持NCI赞助或支持的临床试验。承包商接收并检查全球制造商和供应商的代理商。在指定的受控温度条件下，代理商被库存并存储在有害的，受监控的，受到火灾保护的仓库中。计算机记录将帐户保持帐户的每个步骤的每个座席的收据，存储，分发和最终处置。当临床试验地点的注册NCI研究人员需要进行NCI研究的代理供应，临床试验地点提交了称为临床药物请求（CDR）的命令。该请求指定了所需的协议，代理，强度和数量以及其他必要的信息，也将发送给PMB进行批准。经过批准后，运输记录在存储库中打印出来，将代理包装到运输容器中，以使代理在适当的环境条件下完整地交付到临床站点。所有代理都使用经过验证的托运人和方法发货。向世界各地的调查人员开了货。所有人员均接受了危险和生物材料的处理，存储，运输和处置的培训。承包商符合许多联邦机构的适用准则和法规，包括但不限于FDA的OSHA，EPA，DOT，IATA和良好的制造实践（GMP）。为了支持随机，双盲临床试验，承包商为各个临床部位提供了存储，特定于患者的盲目标签，详细的记录保存和分销服务。 PMB的承包商从患者特定的信息和治疗分配中收到了批准的在双盲诊所试验上进行特定于患者的货物的要求。打印和检查个人，盲人的容器标签，并在运送到调查人员之前，将适当的产品（代理或安慰剂）拉，标记和检查。