Investigational Drug Service Shared Resource

研究药物服务共享资源

基本信息

批准号：
10641716
负责人：
Barbara Todaro
金额：
$ 7.68万
依托单位：
ROSWELL PARK CANCER INSTITUTE CORP
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-06-16 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10641716
关键词：
Accountability Adoptive Cell Transfers Cancer Center Support Grant Cell Therapy Clinical Clinical Investigator Clinical Pharmacology Clinical Protocols Clinical Research Clinical Services Clinical Trials Clinical Trials Unit Communities Comprehensive Cancer Center Consent Data Development Disease Documentation Drug Interactions Drug Kinetics Drug usage Education Enrollment Ensure Equipment and supply inventories Evaluation Funding Future Goals Good Clinical Practice Home Immunotherapy Institution Intervention Investigation Investigational Drugs Leadership Malignant neoplasm of ovary Monitor Outcome Patient Education Patient Participation Patients Peer Review Pharmaceutical Preparations Pharmaceutical Services Pharmacists Pharmacy facility Phase Physicians Preparation Procedures Process Protocols documentation Recommendation Regulation Reporting Research Personnel Research Subjects Resource Sharing Resources Role Safety Security Services Source Standardization Strategic Planning Testing Time Translational trial Writing cancer care clinical development clinical research site clinical trial participant data integrity early phase clinical trial expiration feasibility trial innovation member metabolomics participant enrollment participant safety patient safety precision medicine programs tool

项目摘要

The goal of the Investigational Drug Service Shared Resource (IDS) is to provide a centralized resource for comprehensive pharmacy support for all Clinical Investigators and patients enrolled in clinical trials at Roswell Park. IDS establishes and implements processes and procedures that ensure study drug use is in accordance with all federal, state, institutional, and sponsor regulations governing clinical research. The IDS provides a wide array of services tailored to the clinical protocol-specific needs, including critically important services to Roswell Park CCSG members that ensure regulatory rigor, high quality pharmacy services and including preparation of investigational agents, and safety of clinical trial participants. The IDS is critical for facilitating the conduct of treatment intervention clinical trials by maintaining regulatory rigor and subject safety. IDS has been delegated all aspects of investigational drug management in order to ensure safe provision of study medications to research subjects enrolled in treatment intervention clinical trials. Importantly, IDS leadership and staff are members of the Early Phase Clinical Trial (EPCT) unit and can support the development of all early phase translational trial development. In conjunction with Dr. Robert Bies (Bioanalytics, Metabolomics & Pharmacokinetics Shared Resource), who is also a member of EPCT, IDS supports development of clinical pharmacology aspects of CCSG program protocols. In the reporting period (2013-2017), the IDS served a total of 73 Roswell users, of which 44 (60%) were CCSG members. The Specific Aims of the IDS are: 1) To evaluate treatment intervention clinical trials for feasibility and facilitate protocol review: IDS participates in the PRMS process for all treatment intervention clinical trials; 2) To manage investigational agents for all treatment intervention clinical trials in accordance with Good Clinical Practice (GCP) standards: IDS has developed standard operating procedures for ordering, receiving, storage, dispensing, preparation and destruction of all study medications; 3) To provide clinical services essential for safety of patients participating in treatment intervention clinical trials: IDS pharmacists ensure patient safety by (i) assessing for potential drug interactions with investigational agents; and (ii) providing education for patients taking investigational agents at home to ensure patient safety and data integrity. In alignment with Roswell Park's strategic plan to enhance innovative cancer care especially in immunotherapy and precision medicine, it is anticipated that the complexity of treatment intervention clinical trials will continue to increase over the next five years.

研究药物服务共享资源（IDS）的目标是为为所有参加Roswell临床试验的临床研究人员和患者的综合药房支持公园。 IDS建立和实施过程和程序，以确保研究药物使用符合所有联邦，州，机构和赞助商法规都涉及临床研究。 IDS提供了针对特定于临床方案的需求量身定制的各种服务，包括至关重要的服务罗斯威尔公园CCSG成员，确保监管严格，高质量的药房服务以及包括研究剂的准备和临床试验参与者的安全。 IDS对于促进通过维护严格和受试者的安全性来进行治疗干预临床试验。 IDS有被委派了研究药物管理的各个方面，以确保安全提供研究接受治疗干预临床试验的研究对象的药物。重要的是，IDS领导力员工是早期临床试验（EPCT）部门的成员，可以支持所有人的发展早期转化试验开发。与Robert Bies博士（生物分析，代谢组学和药代动力学共享资源），也是EPCT的成员，IDS支持临床的发展 CCSG计划方案的药理学方面。在报告期（2013-2017）中，IDS总计在73个罗斯威尔用户中，其中44位（60％）是CCSG成员。 ID的具体目的是：1）评估治疗干预临床试验的可行性和促进协议审查：IDS参与所有治疗干预临床试验的PRMS过程； 2）管理所有治疗的研究剂干预临床试验根据良好的临床实践（GCP）标准：IDS已开发订购，接收，存储，分配，准备和破坏所有的标准操作程序研究药物； 3）为参加治疗的患者的安全提供必不可少的临床服务干预临床试验：IDS药剂师通过（i）评估潜在的药物相互作用来确保患者的安全与研究代理人；（ii）为将调查人员在家中接受调查人员的患者提供教育确保患者的安全和数据完整性。与罗斯威尔公园（Roswell Park）的战略计划保持一致，以增强创新性癌症护理尤其是免疫疗法和精确医学，预计治疗干预临床试验将在未来五年内继续增加。