Abstract A106: Patient, provider, protocol, and health systems barriers to cancer clinical trial accrual at an academic medical center: Identifying interventions to increase representation of racial/ethnic minorities

2011 ◽  
Author(s):  
James Ward ◽  
Blase Polite
Keyword(s):  
Clinical Trial ◽  
Ethnic Minorities ◽  
Health Systems ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cancer Clinical Trial ◽  
Academic Medical ◽  
Clinical Trial Accrual ◽  
Racial Ethnic

scholarly journals Integration of an Academic Medical Center and a Large Health System: Implications for Pharmacy

2019 ◽  
Vol 54 (3) ◽  
pp. 170-174
Author(s):  
Brian L. Erstad ◽  
Tina Aramaki ◽  
Kurt Weibel
Keyword(s):  
Health System ◽  
Health Systems ◽  
Integration Method ◽  
Medical Center ◽  
Academic Medical Center ◽  
Lessons Learned ◽  
Faculty Members ◽  
Pharmacy Services ◽  
Academic Medical ◽  
High Level

Objective: To provide lessons learned for colleges of pharmacy and large health systems that are contemplating or in the process of undergoing integration. Method: This report describes the merger of an academic medical center and large health system with a focus on the implications of the merger for pharmacy from the perspectives of both a college of pharmacy and a health system’s pharmacy services. Results: Overarching pharmacy issues to consider include having an administrator from the college of pharmacy directly involved in the merger negotiation discussions, having at least one high-level administrator from the college of pharmacy and one high-level pharmacy administrator from the health system involved in ongoing discussions about implications of the merger and changes that are likely to affect teaching, research, and clinical service activities, having focused discussions between college and health system pharmacy administrators on the implications of the merger on experiential and research-related activities, and anticipating concerns by clinical faculty members affected by the merger. Conclusion: The integration of a college of pharmacy and a large health system during the acquisition of an academic medical center can be challenging for both organizations, but appropriate pre- and post-merger discussions between college and health system pharmacy administrators that include a strategic planning component can assuage concerns and problems that are likely to arise, increasing the likelihood of a mutually beneficial collaboration.

Accelerating the clinical trial start-up process for early-phase cancer studies: A test of process change to support rapid activation in an academic medical center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17507-e17507 ◽  
Author(s):  
Sheilah K Hurley ◽  
Therica M Miller ◽  
Rebecca Flores Stella ◽  
Keren Dunn ◽  
Ryan Schroeder ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cancer Center ◽  
Small Series ◽  
Academic Medical ◽  
One Year ◽  
Activation Times ◽  
High Level

e17507 Background: Clinical trial sponsors have strong scientific, financial, and regulatory interests in rapidly activating studies at participating sites. Academic medical centers have difficulty activating trials within a few weeks of sponsor agreement because, among other inefficiencies, they engage the necessary committee reviews, regulatory approvals, contracting, and budgeting in serial fashion. Incremental revisions in such workflows do not result in strong improvements. Methods: We redesigned our institutional workflow to complete clinical trial activation tasks within six weeks. Historical procedures were replaced rather than scrutinized. A high level leadership committee was required to change and integrate procedures across the medical center, and engage sponsors to improve their turnaround times. A web-based collaborative workflow tracking tool was created to help coordinate the necessary tasks and measure performance. Six clinical trials from the Cancer Center portfolio were used to test and improve the new workflow. Results: Clinical trial activation redesign took one year. For the six studies used as tests of change, the activation times were 49, 54, 78, 58, 62, and 32 days. Times in excess of 6 weeks were largely due to sponsor delays. Conclusions: Considerable effort is required to significantly alter a complex workflow like clinical trial activation. Appropriate priorities, leadership, staffing, and tools are required. Markedly shortened study activation for a small series of cancer trials taught our academic medical center lessons that will be useful for improving the process for all clinical trials, and will make us a better partner for pharmaceutical and academic sponsors as well as for investigator initiated research. [Table: see text]

scholarly journals Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development (Preprint)

2017 ◽  
Author(s):  
Yu Rang Park ◽  
Young Jo Yoon ◽  
HaYeong Koo ◽  
Soyoung Yoo ◽  
Chang-Min Choi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Medical Center ◽  
Academic Medical Center ◽  
Trial Management ◽  
Privacy And Security ◽  
Academic Medical ◽  
Asan Medical ◽  
Clinical Trial Management

BACKGROUND Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. OBJECTIVE The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. METHODS This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. RESULTS In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. CONCLUSIONS The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

A compounding compliance team at an academic medical center

2020 ◽  
Vol 77 (11) ◽  
pp. 882-891 ◽  
Author(s):  
Bruce W Chaffee ◽  
Jamie C Tharp ◽  
John S Clark ◽  
Stanley Kent
Keyword(s):  
United States ◽  
Health Systems ◽  
Medical Center ◽  
Academic Medical Center ◽  
The United States ◽  
Infection Prevention And Control ◽  
Regulatory Requirements ◽  
Record Keeping ◽  
Academic Medical ◽  
Regulatory Bodies

Abstract Purpose Highly publicized safety issues arising from poor sterile compounding practices in facilities around the United States have garnered substantial attention in recent years. This attention has led to increased scrutiny of health systems by regulatory bodies, new regulatory requirements, and changes to existing regulations or their interpretation. Health systems are often resource constrained, and the added work resulting from this scrutiny challenges pharmacy departments in meeting regulatory requirements and United States Pharmacopeia chapter 797 standards for sterile compounding. This article describes the creation of a dedicated compounding compliance team (CCT) and the team’s responsibilities in support of pharmacy operations in achieving compliance with those standards. Summary Visits to our organization by several regulatory bodies resulted in findings that required substantial work in order to achieve compliance with sterile compounding standards. Given the number and complexity of findings and the need for timely resolution, it was felt that specialized staff were needed to understand, evaluate, and correct identified deficiencies and help the already overburdened staff and leadership comply with existing standards. A CCT was formed, and work was simultaneously initiated on ensuring proper credentialing and training of all compounding staff, development of standard operating procedures, improvements in facilities, environmental monitoring, equipment certifications, practice auditing, and documentation. Key activities of the team included strategic planning, building relationships, communicating with stakeholders, self-education, and record keeping. Key partners included environmental services, facilities, and infection prevention and control personnel and departmental staff and leaders. Conclusion The formation and collaborative work of a CCT at an academic medical center was successful in changing the culture of the organization and achieving compliance during visits from several regulatory agencies.

Gender differences in career progress and satisfaction in an academic medical center

2002 ◽  
Vol 2 (3) ◽  
pp. 95-104 ◽  
Author(s):  
JoAnn Manson ◽  
Beverly Rockhill ◽  
Margery Resnick ◽  
Eleanor Shore ◽  
Carol Nadelson ◽  
...  
Keyword(s):  
Gender Differences ◽  
Medical Center ◽  
Academic Medical Center ◽  
Academic Medical ◽  
Career Progress
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