In the wake of the COVID-19 pandemic, 35 industry giants from both the oncology and biopharma worlds including Johnson & Johnson, Novartis and more are calling for permanent global changes in cancer treatment and delivery.
The call comes from the Bloomberg New Economy International Cancer Coalition, a group promoting “intentional implementation” of its proposals. The group, established in spring 2021, includes big names such as Amgen, Bayer, the Dana-Farber Cancer Institute, Genentech, Johnson & Johnson, Johns Hopkins, Novartis and the FDA’s Oncology Center of Excellence. The group formed with the lofty mission of improving patient access to clinical trials worldwide and coordinating regulations that may accelerate cancer cures and prevention post-pandemic.
As the reality of the pandemic hit in 2020, patients stopped signing up for trials and clinic visits were canceled. Clinical trials—the lifeblood of any pharmaceutical company or biotech—were forced to pivot or shut down.
Decentralized clinical trials, around before the pandemic, suddenly became one of the few ways to keep research going, with Novartis and J&J swiftly pivoting to mailed medicines and home health visits among other strategies reported by major companies.
“At the end of the day, I think the feeling was that we can't let the patients down just because we're dealing with COVID issues,” Craig Tendler, M.D., vice president of clinical development and global medical affairs, oncology, for J&J’s Janssen unit, said at the time. “We have to continue to support the patients in the studies and also continue to pursue some of these novel treatments that could ultimately have a major benefit.”
Now—more than two years after COVID-19 emerged—the Bloomberg coalition argues telemedicine and remote technologies can deliver better cancer care for underserved populations. In a consensus paper published April 19 in Nature Medicine, the group contends that clinical trial flexibilities allowed amid the pandemic provided new opportunities to enhance patient experience and showed the potential technology and global collaboration have to improve participant access and diversity.
“The goal is to bring the trial to the patient, maintaining established clinician-patient relationships of trust,” said Bob Li, M.D., an oncologist at Memorial Sloan Kettering Cancer Center, a physician ambassador to China and the Asia-Pacific region and the lead author of the piece.
The coalition determined that patient identification and enrollment, treatment and monitoring, and regulatory harmonization across patient-centric clinical trials—investigations that prioritize patient needs at all stages—were the top priorities to focus on. In that line, the authors believe patient-centric care may be achieved by reducing obstacles to trial participation; leveraging technologies such as telemedicine, remote monitoring and liquid biopsy; and with international collaboration including regulatory harmonization.
The coalition cites three initiatives that exemplify international collaboration and regulatory harmonization, including the FDA-initiated Project Orbis, an alliance of government regulatory agencies from eight countries that submit and review new oncology products. The authors also named China’s National Medical Products Administration, which has approved several oncology products based on international data after joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and detailed the recent emergence of the European Union Clinical Trials Regulation as well.
The 35 coalition members will implement certain proposed actions based on institution type. Joining Novartis and J&J are BeiGene, Daiichi Sankyo, Zai Lab and many other U.S. and international organizations and agencies.
Academic medical centers and pharmaceutical players have committed to incorporating technologies in clinical trial protocols to improve patient access and diversity as well as to removing barriers to trial participation. Diagnostic companies pledge to develop digital solutions to match trials to diverse patient communities, particularly in underserved areas, and to accelerate trial enrollment, while regulatory authorities will expand existing cross-regional efforts to minimize redundancy and delays. Meanwhile, patient advocacy groups and nonprofits have committed to empowering patients through education and increased patient contribution to trial designs.
“With a coordinated, global multi-stakeholder effort, we absolutely can convert these improvements to a permanent paradigm change in cancer patient medicine post-pandemic,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and an author on the paper.
The authors urge all cancer stakeholders to adopt principles of the proposed strategies, concluding there is an “unprecedented opportunity for a post-pandemic era of international collaboration to accelerate the eradication of cancer.”