CORE--RESEARCH PHARMACY

Univ Of Med/Dent Nj-R W Johnson Med Sch, Piscataway NJ

Investigators

Linked publications, trials & patents

Abstract

The Research Pharmacy opened in the fourth quarter of 1993 and has since provided support for the rapidly expanding clinical research activity at CINJ. Its development parallels that of the Clinical Research Office, and together these shared resources provide the critical support for the high-quality clinical research at CINJ. Dr. Goodin has been the director of the Research Pharmacy from the time of its inception. Since the last submission of the CCSG, the Research Pharmacy operated through institutional funds and chargebacks. During this time, the young investigators in the CINJ Clinical Investigations Program acquired peer- reviewed grant support (R03, R01, R21, Komen Foundation, etc.,) and the Protocol Review and Monitoring System was approved. With the growth of the clinical research activity at CINJ, the usage of this shared resource grew and now meets the criterion for shared resource funding in that a significant portion of usage of this resource is through peer-reviewed, funded project. The overall goal of this shared resource is to support CINJ member clinical research by providing research pharmacy services. The specific objectives of this shared resource are as follows: 1. To develop and maintain appropriate methods for handling investigational agents. 2. To expedite procurement, provide secure storage, and ensure that investigational agents are used according to protocol guidelines. 3. To provide expert consultation on the use of new agents with regard to drug interactions, sequencing, formulation, and safety. 4. To assist CINJ investigators in meeting all regulatory agencies' requirements for drug accountability, and for reporting adverse events. 5. To provide quality assurance by checking consents, verifying patient eligibility, reviewing dosage calculations, and checking for potential drug interactions. The Research Pharmacy is used by 15 members, from five CINJ programs, representing three academic departments. CINJ members represent 100% of all users of this shared resource. While this is a new shared resource, total usage is projected to increase dramatically over the course of this grant period because of the growth of the CINJ phase I and pilot studies. This projection is based on the continued increase in patient accrual onto trials (current accrual is approximately 85 patients/quarter), which is currently more than 400% greater than at the time of the submission of the prior CCSG grant. This services of the Research Pharmacy results in a high degree of safety and compliance with research protocols that are approved by the Protocol Review and Monitoring System. The institution has committed the resources to add additional personnel and space as warranted by usage to meet CINJ user demands.