Robert Daly and Bob Li
A commentary by members of Memorial Sloan Kettering Cancer Center’s (MSK) Bobst International Center along with members of the Bloomberg New Economy International Cancer Coalition (the “Coalition”) calls for global collaboration to reimagine patient-centric cancer clinical trials. The piece was published in the April 19, 2022, “The Future of Cancer Research” special Focus edition of the journal Nature Medicine.
The COVID-19 pandemic upended the infrastructure and delivery of oncology treatment and clinical trials worldwide, illustrating the need for international cooperation to continue delivering breakthrough therapies. The commentary outlines the importance of harnessing technologies such as telemedicine, enhanced diagnostic capabilities, and remote monitoring to improve cancer clinical trials in the future.
The pandemic also revealed how technology and global collaboration can broaden access to cancer clinical trials. Despite the crucial purpose clinical trials serve in translating science to care, only 2% to 8% of cancer patients are enrolled in clinical trials globally. During the pandemic, government regulators, medical centers, and clinical trial sponsors implemented unprecedented flexibilities in clinical trial conduct. This provided new opportunities to optimize the patient experience to improve access, alleviate patient burden, and increase the diversity of participants, including those in remote and disadvantaged communities.
“In this commentary, we explore ways to achieve better access to clinical trials and regulatory harmonization that will accelerate the development of novel cancer treatments, screening, and prevention,” said Bob T. Li, MD, PhD, MPH, medical oncologist and Physician Ambassador to China and Asia-Pacific at MSK, and lead author on the new Nature Medicine piece. “Such a multi-stakeholder effort requires new imagination of patient-centric trials and brings an unprecedented opportunity for a post-pandemic era of international collaboration to accelerate the eradication of cancer.”
The commentary recommends three main action areas to move forward a new model of cancer care:
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Patient identification and enrollment: leveraging hub and spoke networks — Many clinical trials are limited to academic medical centers. In the United States, 74% of cancer patients receive treatment in their communities, and a recent study found that no trials were offered in 36% of physician-owned practices. For many patients, their local oncologists must advise and refer them to clinical trials conducted at other institutions, creating an extensive barrier to access. In the commentary, authors suggest that information technology tools should be part of the solution, including building an interactive international database for patients. Once patients are matched to trials, enrollment could be managed by a hub-and-spoke network where academic or large community cancer centers serve as a hub for distributed clinical research sites or the patients’ homes in the wider community.
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Treatment and monitoring: enhancing remote and hybrid models — Participation in oncology clinical trials often requires inconvenient and lengthy appointments and costly procedures such as imaging, biopsies, and on-protocol treatment, which all create obstacles for patients who lack the time and means necessary to participate. Leveraging telemedicine technology for remote consent, toxicity monitoring and follow-up, local laboratory and imaging studies, and remote shipment of oral medicines to patients’ homes could result in greater access to clinical trials.
- Regulatory harmonization: lowering barriers to patient-centric care across the globe — In the commentary, the authors argue that the lack of harmonization among international regulatory policies is the most consequential barrier in worldwide efforts to develop novel strategies for cancer treatment and prevention. Currently, there is no international diagnostics standard for cancer molecular profiling. Regulatory restrictions on international cancer genetics data sharing may also prevent translational science discoveries and impede early-phase novel drug development. And there is a lack of legal and regulatory policy to guide telemedicine and remote monitoring both in the U.S. and internationally. Several current examples demonstrate the potential benefits of international collaboration and regulatory harmonization, including Project Orbis, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the European Union Clinical Trials Regulation.
“By leveraging technology and collaboration, we see a future where the patient’s needs are prioritized at all stages of cancer clinical trials,” said Robert Daly, MD, MBA, MSK medical oncologist and the piece’s co-first author.
The Coalition brings together academia, industry, government, patient advocacy, and policy think tanks to leverage technology and collaboration to improve patient access to clinical trials and to harmonize regulations aiming to accelerate cancer cures and prevention worldwide in the post-pandemic era. It comprises leaders from academic medical centers, government regulatory agencies, the pharmaceutical and biotechnology industry, contract research organizations, patient advocacy groups, and policy think tanks. Founding members of the Coalition include MSK, Asia Society, and McKinsey Cancer Center.
Contact:
Annik Allen
(508) 243-1919
allena5@mskcc.org