As reported in the Journal of Clinical Oncology, Vose et al have provided a summary of the groundwork of an initiative by ASCO and the Association of American Cancer Institutes (AACI) to identify and reduce administrative and regulatory burdens in the conduct of cancer clinical trials. The initiative—Best Practices in Cancer Clinical Trials Initiative—is aimed at promoting practical solutions to meet existing regulatory and administrative requirements.
The initiative components described here were overseen by a multidisciplinary working group of hematologists/oncologists, research nurses, administrators, managers, and industry representatives, with input from U.S. Food and Drug Administration (FDA) and National Cancer Institute officials, contract research organization staff, and patient advocates. Thus far, the primary components of the project are a stakeholder survey to identify the most pressing issues in this area and an invitational workshop involving leading oncology professionals and policymakers aimed at identifying potential solutions. The report by Vose et al summarized the stakeholder survey and workshop output.
Survey Findings
The survey was sent to approximately 1,200 physician-investigators, research staff, and administrators in academic and community-based research settings in the fall of 2015. A total of 310 responses were eligible for inclusion in the analysis. Physicians constituted 26% of the respondent pool, with the remaining 74% consisting of other research staff, including nurses, administrators, and managers.
The top three burdens identified by respondents were: contract negotiations with sponsors, contract negotiations with contract research organizations, and compliance with industry or contract research organization requirements in the area of getting clinical trials up and running; site monitoring visits, management of regulatory documents, and external adverse event and serious adverse event reporting in the area of conducting trials; and sponsor queries of databases and access to records, sponsor-required closeout activities, and long-term follow-up in the area of posttrial completion activities. In response to questions about the adequacy of the research staff, 58% of respondents indicated they did not have adequate staffing to handle the regulatory burden, and 41% reported not having adequate staffing to monitor regulatory compliance.
Workshop Solutions
In the workshop, discussions on overcoming the challenges with clinical trial contracts yielded the following potential solutions:
For Problems With the Preselection Process:
For Problems With the Negotiation Process:
For Problems with Inter- and Intrainstitutional Contracts:
Discussions on improving clinical trial coverage analyses and budgeting yielded the following potential solutions:
For Problems With Coverage Analysis of Funded Trials:
For Problems With Billing and Coverage of Procedures:
For Problems With Budgeting for Infrastructure and Research Aspects of Trials:
Discussions on complying with regulatory and training requirements yielded the following potential solutions:
For Problems With Training Requirements:
For Problems With Adverse Event/Serious Adverse Event Documentation and Reporting:
For Problems With Auditing, Monitoring Site Visits, Trial Queries, and Documentation:
The authors concluded: “[T]he Initiative’s stakeholder survey and workshop are good first steps toward identifying major inefficiencies and potential solutions for alleviating regulatory and administrative burdens on cancer clinical trials. ASCO and AACI continue to review the list of potential recommendations generated by workshop participants to determine ways that they can leverage ongoing efforts and develop new strategies to effectively and swiftly improve the conduct and management of cancer research.”
Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, Omaha, is the corresponding author of the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.