National Cancer Institute: Restructuring to Support the Clinical Trials of the Future.

OBJECTIVES: To describe the evolution and structure of the National Cancer Institute clinical trials programs, their notable accomplishments, nurses' roles in these accomplishments, and the essential role of nursing today and in the future. DATA SOURCES: Manuscripts, government publications, websites, and professional communications. CONCLUSION: Change is inevitable and a constant factor in the world of advancing science and clinical research. Nurses' contribution to research and evidence-based practice will continue to grow and is vital as the scientific landscape evolves. IMPLICATIONS FOR NURSING PRACTICE: As the understanding of cancer biology increases and clinical trials evolve, nurses will need to remain key team members and leaders in National Cancer Institute Community Oncology Research Program and National Cancer Trials Network trials and their associated infrastructure.

A Rare Opportunity: Examining the Experience of a New Institutional Review Board.

The process of creating a new Institutional Review Board (IRB) or Research Ethics Committee (REC) presents many challenges; however, little has been published to describe this experience. Thus, many questions about creating a new IRB/REC and the challenges they face remain. The establishment of a new federal-wide single IRB provided a rare opportunity to describe these experience and outcomes. A census of the activity and outcomes of this new board is reported for its first 3 years of operation: The convened board approved 50 protocols, required an average of 93.24 days and 2.76 reviews for protocol approval, and issued an average of 31.82 stipulations per protocol. The census data helped to identify several issues that impacted the board's outcomes and it serves as a baseline for future comparisons. The overall dynamics, challenges, and outcomes of this new single IRB are discussed.

Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research.

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

Clinical research education: perspectives of nurses, employers, and educators.

The aim of this study was to understand the current environment around clinical research relating to nursing education and practice. This descriptive study analyzed data from 33 in-depth interviews with faculty members, nurse executives, staff development directors, and practicing nurses, as well as an online interactive brainstorming session with 28 deans of schools of nursing (or their designee). Patterns and themes that emerged within each group were identified and analyzed in relation to study objectives. Central themes emerged around participants' knowledge and attitudes about clinical research education for baccalaureate nursing students, factors enhancing or inhibiting inclusion of clinical research content in baccalaureate nursing programs, and professional roles nursing students could expect to assume after graduation. Although the participants agreed that mastery of clinical research knowledge and related skills is important, there was no agreement whether nurses should receive this education and training in baccalaureate programs or in staff development.

Power of an effective clinical conversation: improving accrual onto clinical trials.

The National Cancer Institute (NCI) is actively transforming clinical trials to revitalize the clinical trials system and improve patient accrual. For more than 30 years, NCI has provided information and communication resources about cancer clinical trials. The Institute supports a clinical trials Web site (www.cancer.gov/clinicaltrials) that receives nearly a half million page views a month. In addition, NCI's Cancer Information Service (800-4-CANCER, chat and e-mail) responds to 1,750 clinical trial inquiries every month. Although these numbers suggest that a high volume of clinical trial information is being exchanged between NCI, the public, and providers, most patients decide whether to participate in clinical trials during the patient-provider interaction.

AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform.

PURPOSE: Present the design and initial evaluation of a unique, Web-enabled platform for the development of a community of practice around issues of oncology clinical trial accrual. METHODS: The National Cancer Institute (NCI) conducted research with oncology professionals to identify unmet clinical trial accrual needs in the field. In response, a comprehensive platform for accrual resources, AccrualNet, was created by using an agile development process, storyboarding, and user testing. Literature and resource searches identified relevant content to populate the site. Descriptive statistics were tracked for resource and site usage. Use cases were defined to support implementation. RESULTS: ACCRUALNET HAS FIVE LEVELS: (1) clinical trial macrostages (prestudy, active study, and poststudy); (2) substages (developing a protocol, selecting a trial, preparing to open, enrolling patients, managing the trial, retaining participants, and lessons learned); (3) strategies for each substage; (4) multiple activities for each strategy; and (5) multiple resources for each activity. Since its launch, AccrualNet has had more than 45,000 page views, with the Tools & Resources, Conversations, and Training sections being the most viewed. Total resources have increased 69%, to 496 items. Analysis of articles in the site reveals that 22% are from two journals and 46% of the journals supplied a single article. To date, there are 29 conversations with 43 posts. Four use cases are discussed. CONCLUSION: AccrualNet represents a unique, centralized comprehensive-solution platform to systematically capture accrual knowledge for all stages of a clinical trial. It is designed to foster a community of practice by encouraging users to share additional strategies, resources, and ideas.