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.
