Image Credit: Andy Studna
In a session at the 2024 DIA Global Annual meeting in San Diego, CA, Jane Myles, program director, Decentralized Trials and Research Alliance (DTRA); Joseph Unger, PhD, MS, associate professor, Fred Hutchinson Cancer Center; Ramya Thota, associate professor, Intermountain Medical Oncology – IMC; and Suanna Bruinooge, chief and division director, Research Strategy and Operations Center, American Society of Clinical Oncology, offered their thoughts on ways to increase patient access to clinical trials through decentralization and flexible design.
Unger started the session with a presentation offering an analysis of data trials conducted during the COVID-19 pandemic, with the goal of assessing whether or not the quality of the data suffered as a result of the public health emergency requiring a number of flexibilities to be administered and adopted rapidly. Recently, the data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.
“The onset of the COVID-19 pandemic as we know resulted in substantial reductions in enrollment to cancer clinical trials,” explained Unger. “In response, researchers, regulators and policy makers rapidly adapted modifications to trial processes. The aim was to enable important research and care to continue both for ongoing trials and for those initiated during the pandemic. They key question as I mentioned upfront is whether the mitigation strategies that were adopted during the pandemic adversely impact the data quality and the integrity of conduct.”
In order to discover an accurate answer to the question, ASCO and the Friends of Cancer Research put together a taskforce that aimed to evaluate the impact of the pandemic on the conduct of cancer clinical trials. Further, the taskforce set out to assess potential changes in data quality as they pertain to protocol deviations, to describe the mitigation strategies that were employed, and to determine the broader impact of the mitigation strategies on the conduct of clinical trials.
Results found the following:
- Enrollment odds decreased by 64%
- During the recovery period, the decrease was 45%
- Protocol deviations, dropouts, and severe adverse events demonstrated lower incidence in the initial wave compared to pre-COVID.
The conversation then shifted to Thota speaking of additional initiatives aiming to extend access and inclusion in clinical trials. She offered a brief background as to how the initiatives started.
“Back in 2021, ASCO formed a clinical task force called the Clinical Trial Access and Participation Task Force,” Thota said. “The main focus of the task force was to look at the structural barriers and how we get improved access to clinical trials. This past January, they released a call to action, mainly to advance patient focus and decentralized clinical trials.”
She also discussed key action items that came out of a stakeholder meeting, which included investigators from academic sites, community sites, and patient advocacy groups that were working to improved centralized clinical trials. The action items included routine acceptance of local and remote patient care and testing has been already done during the COVID times and fostering partnerships to increase patient and local clinician access to the clinical trials.
Myles then stressed that decentralized trial methods are about access for patients. In other words, this means access to sites and technology.
“When DTRA was founded, our leadership council identified three more big areas of focus that led to stakeholder initiatives,” Myles stated. “It came down to definitions and standards, best practices, educational materials, and concepts. Our 12-initiative kicked off in 2021 and now we have completed that initiative work.”
Myles also urged those in the audience to provide feedback if they believed something was missing after steps had been taken to decentralize clinical trials.
“We know that this will get stale without your input as you’re navigating your own clinical trial processes,” said Myles.
Reference
Myles J, Thota R, Bruinooge S, Unger J. Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology. June 18, 2024. 2024 DIA Global Annual Meeting.
