[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.— Julie M. Vose, MD, MBA, FASCO
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As reported in the Journal of Clinical Oncology, Julie M. Vose, MD, MBA, FASCO, of the University of Nebraska Medical Center, Omaha, and colleagues 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.1 The initiative—Best Practices in Cancer Clinical Trials Initiative—is aimed at promoting practical solutions that meet existing regulatory and administrative requirements.
The initiative components described herein were overseen by a multidisciplinary working group of hematologists/oncologists, research nurses, administrators, managers, and industry representatives, with input from the U.S. Food and Drug Administration (FDA) and National Cancer Institute officials, contract research organization staff, and patient advocates. The primary components of the project thus far 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 Dr. Vose and colleagues summarized the stakeholder survey and workshop output.
Survey Findings
The survey was sent in the fall of 2015 to approximately 1,200 physician-investigators, research staff, and administrators in academic and community-based research settings. 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 (1) 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; (2) site monitoring visits, management of regulatory documents, and external adverse event and serious adverse event reporting in the area of conducting trials; and (3) sponsor queries of databases and access to records, sponsor-required closeout activities, and long-term follow-up in the area of post-trial completion activities. In response to questions about adequacy of research staff, 58% of respondents indicated that they did not have adequate staffing to handle regulatory burden, and 41% reported not having adequate staffing to monitor regulatory compliance.
Workshop Solutions
In the workshop, discussions on overcoming 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 nononcologic 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 that they have the same information/understanding about trials/ancillary services.
- Address the cultural disconnect among lawyers, researchers, and sponsors.
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, FASCO, and colleagues
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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 and serious adverse event documentation and reporting:
- Many sponsors overreport adverse events and serious adverse events. Organize a meeting with ASCO and AACI leadership, Clinical Trials Transformation Initiative, 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; 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 electronic data capture system (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.” ■
Disclosure: Dr. Vose has had a consulting or advisory role with Bio Connections and has received (institutional) research funding from Celgene, Genentech, Incyte, Janssen Biotech, Acerta Pharma, Kite Pharma, Seattle Genetics, Novartis, Amgen, Bristol-Myers Squibb, and Allos Therapeutics. For full disclosures of the other study authors, visit jco.ascopubs.org.
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