Perspectives of Oncology Nursing and Investigational Pharmacy in Oncology Research.

OBJECTIVES: This article will provide an overview of the purpose, structure, and function of an investigational pharmacy in oncology clinical research. It will also discuss the role of the oncology nurse in managing investigational drugs (ID) when caring for a patient receiving treatment on a clinical trial and the importance of their role in the trial process. DATA SOURCES: Government regulations, professional guidelines, and best practices. CONCLUSION: ID management for clinical trials is a multidisciplinary process requiring input from various professionals to ensure safe, accurate, and study-specific administration. The nurse's role in the process of clinical trial ID management is dependent on each institution's expectations of clinical research nurses and the scope of their role. IMPLICATIONS FOR NURSING PRACTICE: Multiple nursing roles may be involved in caring for patients who are being treated as part of a clinical trial, including clinical research nurses, infusion nurses, or as nurses providing direct patient care (inpatient or outpatient). Providing education on ID management, specific to the nurse's involvement, is a responsibility of the study team. Ensuring proper safeguards, accurate and protocol-specific delivery and documentation of ID, and completion of patient education are key in the conduct of oncology clinical research.

Construction of Management Model of Clinical Trial Drugs in Our Hospital / 中国药房

OBJECTIVE:To explore the method for the scientific and standard management of clinical trial drugs. METHODS:By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS:In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS:Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and im-prove information management continuously,which is of important significance to construct standardized,detailed and high-effi-ciency centralized management system of clinical trial drugs.

A Study on Current Status of Clinical Trial Pharmacy in Domestic Clinical Trial Institution

BACKGROUND: There is a lack of research on the status of clinical trial pharmacy and clinical trial pharmacist (CTP) in Korea. This study was aimed to investigate the current status of clinical trial pharmacy and clinical trial pharmacists. METHODS: The survey was performed using the 41-item questionnaire designed to investigate information on the following; (1) current status of clinical trial pharmacy designated by Korea Food and Drug Administration, (2) current status of working condition, management, and satisfaction index of CTP. Data collected was analyzed by t-test and chi2. RESULTS: Among the CTPs who responded, 92.7% belonged to department of pharmacy, and 7.3% to clinical trial center. 90.2% of the respondents were women. Forty-two point seven percents of the respondents had more than 3 years of experience in the clinical trial field. 36.6% answered that the current number of CTPs in the institution was '2'. Sixty-three point four percents answered that they subsumed an additional post. Regarding the question on "whether the equipment and working environment of your clinical trials pharmacy is adequate", 65.1% of the respondents answered as 'Inadequate'. Ninety-eight point eight percents answered that work-related education is needed. Ninety-three point nine percents answered that the quality of clinical trials is related to the improvement of the working environment of CTP. CONCLUSION: Clinical trial pharmacy's facility and number of actually working CTP were insufficient. Proper and continuous education and training for CTPs are needed to improve the quality of clinical trials conducted in Korea, with strong institution support and timely regulation change.