The History of Clinical Trials Research: Implications for Oncology Nurses.

OBJECTIVE: To discuss the major milestones in the history of clinical research and how these correlate with the role of the clinical research nurse. DATA SOURCES: Government Web sites, published articles, and grey literature. CONCLUSION: The history of clinical research, drug development, and the regulations has come of age, and as a result clinical oncology research has a more defined scope and purpose. With the Oncology Nursing Society and the International Association of Clinical Research Nurses recognizing the scopes of practice for clinical research nursing, such roles are becoming more prevalent and integrated in oncology. IMPLICATIONS FOR NURSING PRACTICE: It is vital for all clinical research nurses to understand and adhere to the laws and regulations related to clinical trials and human subject protection. The clinical research nurse must ensure good clinical practice and compliance with the regulations to ensure the integrity of the study. There are different types of clinical research, including behavioral, therapeutic, and nontherapeutic studies, where clinical research nurses must understand the treatments and the drug development process to better serve their patients.

Feasibility of a Centralized Clinical Trials Coverage Analysis: A Joint Initiative of the American Society of Clinical Oncology and the National Cancer Institute.

PURPOSE: Clinical trial billing compliance is a challenge that is faced by overburdened clinical trials sites. The requirements place institutions and research sites at increased potential for financial risk. To reduce their risk, sites develop a coverage analysis (CA) before opening each trial. For multisite trials, this translates into system-wide redundancies, inconsistencies, trial delays, and potential costs to sites and patients. These factors exacerbate low accrual rates to cancer clinical trials. ASCO and the National Cancer Institute (NCI) collaborated to address this problem. METHODS: An ASCO Research Community Forum working group proposed the concept of providing centrally developed CAs to research sites at protocol startup. The group collaborated with NCI and billing compliance experts to hold a symposium for key stakeholders to share knowledge, build skills, provide tools to conduct centralized CAs, and strategize about the next steps. RESULTS: Forty-eight attendees, who represented a range of stakeholders, participated in the symposium. As a result of this initiative, NCI directed the Cancer Trials Support Unit to convene a working group with NCI's National Clinical Trials Network (NCTN) and Community Oncology Research Program (NCORP) to develop tools and processes for generating CAs for their trials. A CA template with core elements was developed and is being adapted in a pilot project across NCTN Group and NCORP Research Bases. CONCLUSION: Centralized CAs for multisite trials-using standardized tools and templates-are feasible. They have the potential to reduce risk for patients and sites, forecast budget needs, and help decrease trial startup times that impede patient access and accrual to clinical trials.

Managing clinical trials--frustration or bliss?

The proper financial administration of clinical trials is becoming a major priority and necessity for involved institutions. The Office of Inspector General in the Department of Justice is sharpening its radar on this growing field. Institutions involved in the conduct of a clinical trial need to become more proactive in the financial management to successfully pass audits and improve financial outcomes. Budget tools standardizing itemized costs can be built to aid clinical trials managers. Using tools already available in a clinic or hospital setting can help even the most junior budget negotiator. Establishing guidelines to streamline and aid the management of a clinical trial program will make managing less challenging.