Research sites and investigators face an ever-increasing number of challenges in the conduct and management of cancer clinical trials. Many of these challenges stem from the multitude of requirements for clinical trials that sponsors and regulatory and administrative agencies have set.
In recognition of the importance of facilitating clinical trials and trial participation, Past ASCO President Julie Vose, MD, MBA, FASCO, made one of her presidential priorities to minimize administrative and regulatory burdens on research sites. In 2015, ASCO partnered with the Association of American Cancer Institutes (AACI) to tackle these challenges through the Best Practices in Cancer Clinical Trials Initiative. Daniel F. Hayes, MD, FACP, FASCO, 2016–2017 ASCO President, continued this initiative.
The Best Practices in Cancer Clinical Trials Initiative
THE GOAL of this initiative is to establish and promote practical solutions to common regulatory and administrative challenges to conducting and managing clinical research. In 2015, ASCO and AACI led a multistakeholder survey to identify and prioritize the most burdensome regulatory and/or administrative aspects of clinical trials. A total of 310 respondents provided feedback on the major challenges related to trial start-up, conducting trials, and trial completion. Based on the results of the survey, three key topics emerged as particularly burdensome: 1) clinical trial contracting, 2) clinical trial coverage analyses and budgeting, and 3) training and regulatory requirements.
ASCO convened a multistakeholder meeting with representatives from academic and community practices, the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), industry sponsors, contract research organizations (CROs), and patient advocacy organizations to develop feasible and practical solutions to the identified burdens. The workshop produced several potential solutions for each challenge. In 2016, ASCO published an article1 detailing the Best Practices in Cancer Clinical Trials Initiative survey, workshop, and resulting recommendations.
Streamlining Adverse Events Reporting
ASCO’S VOLUNTEER-DRIVEN Cancer Research Committee and Research Community Forum Council completed a post-workshop survey to prioritize ASCO’s next steps in implementing and disseminating the solutions developed during the Best Practices in Cancer Clinical Trials Initiative’s stakeholder meeting. Based on this feedback, the Society chose to pursue solutions related to reporting adverse events, clinical trial insurance coverage, and clinical trial management.
In March, ASCO hosted a meeting on streamlining adverse events reporting, with the goal of developing a road map for making the adverse events reporting process as meaningful and informative as possible. Multiple stakeholder groups were invited to participate, including researchers, the FDA, the NCI, industry sponsors, and CROs. The workshop explored some of the primary difficulties with safety reporting for these stakeholders, including the volume of adverse events reports, the fact that a majority of submitted adverse events reports are uninformative, and the lack of harmonization across international regulatory agencies.2 Addressing these problems is critical given that an inadequate adverse events reporting process can compromise detection of valid safety signals and, thus, potentially cause harm to clinical trial participants and patients.
The workshop included an overview of the FDA’s regulations on safety reporting, existing initiatives to improve the adverse events reporting process, and sponsor and CRO perspectives on internal safety reporting practices. The meeting attendees participated in breakout session discussions to determine adverse event reporting best practices and to identify areas for ASCO’s involvement moving forward. Specifically, the breakout groups developed recommendations related to improving the adverse events reporting process for sponsors, CROs, investigators, and research sites, as well as recommendations to improve the use of technology in the adverse events reporting process.
The recommendations for sponsors focused on dissemination and implementation of sponsor best practices based on guidance from companies that have implemented institutional changes that greatly reduced the number of uninformative adverse events reports sent to the FDA and investigations. Recommendations for research sites and researchers included reducing inconsistencies in the safety reporting process through education and standardization of reporting processes. The technology solutions focused on centralizing electronic data collection and reporting. For example, the NCI is currently implementing technology solutions to reduce adverse events reporting burdens by integrating electronic adverse events submission systems for the Cancer Therapy Evaluation Program and facilitating safety data review using Web-based reporting. The FDA is also exploring technology as a means to reduce burden and increase efficiency of the submission and review process for adverse events reports.3
ASCO’s next steps are to disseminate the workshop’s recommendations. This year’s ASCO Annual Meeting included an Education Session, “Best Practices for Clinical Research,” which highlighted the Best Practices in Cancer Clinical Trials Initiative and the workshop on streamlining adverse events reporting.
The Society is also continuing to engage stakeholder groups on this issue, with another meeting planned this year to disseminate the adverse events workshop recommendations to a broad group of trial sponsors. Meanwhile, a forthcoming white paper will provide more details about the specific recommendations developed during the adverse events workshop.
Research Community Forum and Working Group
AS PART of ASCO’s larger efforts to support cancer researchers and research sites, the Society also hosts the Research Community Forum,4 a volunteer-driven initiative currently chaired by Michael Thompson, MD, PhD. Its mission is to develop solutions to common challenges in cancer research and to foster collaboration among researchers. It achieves this goal by holding an Annual Meeting and developing tools and resources that alleviate burdens associated with managing clinical trials, meeting regulatory and sponsor requirements, and centralizing sponsor requests. To date, the Forum has developed tools and resources for assessing clinical trial–associated workload,5 evaluating research program quality,6 and improving the contract negotiations process.7 The Forum also maintains an online library of clinical trial resources, covering topics such as basics for starting a research program, program administration, and budget management.8
The Research Community
Forum has undertaken several projects intended to address the challenges in conducting and managing clinical trials that were identified during the Best Practices in Cancer Clinical Trials Initiative. In 2015, the Forum assembled a Working Group focused on research site burdens associated with billing compliance and insurance coverage analysis prior to opening clinical trials. It collaborated with the NCI to develop recommendations for centralizing coverage analyses of clinical trials.9 The NCI is now piloting this centralized approach to coverage analysis by providing completed analyses to research sites participating in select trials.
The Working Group is also currently developing a training workshop and toolkit to help research sites meet the requirements for clinical trial insurance preauthorizations and to provide strategies for preventing and addressing insurance denials. The workshop and toolkit will be presented during the 2017 ASCO Research Community Forum Annual Meeting, to be held September 24 and 25 at ASCO’s headquarters in Virginia.
The Forum’s Annual Meeting convenes cancer researchers and research staff, with a large majority of attendees coming from community-based sites. The meeting allows participants to network and collaborate, share best practices, and discuss barriers and identify solutions to common challenges in clinical research. The Forum also gathers feedback on its priorities and initiatives for the upcoming year at the meeting. This year’s meeting will feature a workshop on clinical trial insurance coverage, as well as presentations and discussions on challenges in conducting and managing clinical trials and fostering research partnerships.
Other ASCO Clinical Trial Improvement Initiatives
ASCO’S COMMITMENT to improving the conduct and efficiency of cancer clinical trials is not limited to these efforts. The Society recently launched the Center for Research & Analytics (CENTRA) in an effort to better support its research activities. As the new hub of research, analysis, and data management, CENTRA aims to support ASCO’s mission to conquer cancer by generating, integrating, analyzing, and sharing oncology data with the goal of fostering innovation in research and patient care. Facilitating clinical trial engagement by tackling administrative and regulatory burdens in the conduct and management of clinical trials continues to be a priority for CENTRA and ASCO moving forward. ■
4. ASCO Research Community Forum. Available at asco.org/research-progress/research-community-forum. Accessed May 12, 2017.
6. ASCO Research Program Quality Assessment Tool. 2016. Available at asco.org/research-progress/research-community-forum/forum-projects-and-tools. Accessed May 16, 2017.
8. ASCO Clinical Trial Resources. Available at asco.org/research-progress/clinical-trials/clinical-trial-resources. Accessed May 12, 2017.
© 2017. American Society of Clinical Oncology. All rights reserved.