ASCO and AACI Collaborate on Initiative to Reduce Administrative and Regulatory Burden in Cancer Clinical Trials
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:
- Develop master agreements between sites and sponsors to cover agreements that do not vary across trials.
- Certify research programs or register sites on a common platform.
For Problems With the Negotiation Process:
- Develop a centralized repository of templates and tips for negotiating contracts.
- Educate legal staff about real-world risks and existing templates.
- Develop metrics for comparing and reporting legal staff/organization performance.
- Identify incentives to promote the use of existing templates.
For Problems with Inter- and Intrainstitutional Contracts:
- Engage stakeholders to create a worksheet that identifies all non-oncology services for each specific trial.
- Identify best practices around subcontracting and strategies for engaging external departments and independent providers.
- Identify a value proposition for external providers.
- Educate all stakeholders to ensure they have the same information/understanding about trials/ancillary services.
- Address the cultural disconnect among lawyers, researchers, and sponsors.
Discussions on improving clinical trial coverage analyses and budgeting yielded the following potential solutions:
For Problems With Coverage Analysis of Funded Trials:
- Develop an application that allows sites to conduct coverage analyses quickly and effectively.
- Create common language and clinical standards that account for differences across regions/states and providers.
- Provide training to sites on how to conduct coverage analyses.
For Problems With Billing and Coverage of Procedures:
- Conduct universal coverage analyses.
- Develop guidelines around what constitutes routine patient care vs research.
- Purchase in bulk one or more clinical trial management systems to minimize the cost to sites of purchasing this software.
- Develop an article that illustrates several coverage analyses case studies from completed trials.
For Problems With Budgeting for Infrastructure and Research Aspects of Trials:
- Create a common language for research-related costs.
- Develop a list of the items that need to be included in the budget. Research sites could then determine the costs for each item.
Discussions on complying with regulatory and training requirements yielded the following potential solutions:
For Problems With Training Requirements:
- Inventory existing initiatives and resources that could be leveraged in future efforts.
- Identify and harmonize all training requirements.
- Provide more effective training to reduce frequency and ensure retention.
- Develop a system or tool that centralizes training.
For Problems With Adverse Event/Serious Adverse Event Documentation and Reporting:
- Sponsors overreport adverse events/serious adverse events. Organize a meeting with ASCO and AACI leadership, the Clinical Trials Transformation Initiative, the FDA, and other sponsors to discuss strategies for increasing compliance with FDA guidance.
For Problems With Auditing, Monitoring Site Visits, Trial Queries, and Documentation:
- Convene stakeholders to review FDA guidelines (risk-based monitoring, selective safety-data collection, and protocol-design guidelines) and examine why there has been a failure to adopt them; discuss how the protocol design drives what data are collected; and establish clarity about regulatory requirements to address concerns and fears about meeting regulatory requirements, which lead to overcollection of data.
- Use common data elements and a single system for electronic data capture (ie, collect data the same way to allow for better meta-analyses). Certify research programs or register sites.
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®.
