Thirty-five members of the Bloomberg New Economy International Cancer Coalition issued a call for a permanent change to the way cancer is diagnosed and treated around the world.
Thirty-five members of the Bloomberg New Economy International Cancer Coalition issued a call for a permanent change to the way cancer is diagnosed and treated around the world. The group published a commentary in Nature Medicine where they noted that the COVID-19 pandemic impacted clinical trials globally, which “implemented unprecedented flexibilities in the conduct of clinical trials.”
And they’d like to see more of that. The Coalition points out that regulatory agencies in the U.S., China, Russia, the European Union, Brazil, Australia and Nigeria separately issued guidance that their countries adopted, which “provided new opportunities to optimize the patient experience and illuminated how digital technology and collaboration may improve access, alleviate the patient burden and increase the diversity of participants, including those in remote and disadvantaged communities.”
Patient-centricity was already becoming a priority ahead of the pandemic, meaning making clinical trials easier and more accessible for patients. But as the pandemic shuttered many clinical trials or forced them to restructure for so-called decentralized clinical trials (DCT) or a hybrid approach, the trend became even more pressing.
The commentary calls for “a coordinated, global multi-stakeholder effort.” The Coalition is a response to that, which came about after discussions on East-West collaborations between global leaders and experts at the 2019 Bloomberg New Economy Forum held in Beijing. The Coalition pulled together leadership from a broad range of stakeholders, including academic medical centers, regulatory agencies, biopharma industry, contract research organizations and patient advocacy groups to discuss obstacles and solutions. Since July 2021 the members have been convening regularly on how to create better access to clinical trials “and regulatory harmonization that will accelerate the development of novel cancer treatments, screening and prevention.”
Eventually, they settled on three top priorities: patient identification and enrollment, treatment and monitoring and regulatory harmonization.
For patient identification and enrollment, they identified key barriers like lack of integration of patient care and clinical research, inequitable access to biomarker testing and next-generation sequencing (NGS) and trial availability in the local area.
Their proposed strategy is the use of electronic health records that can link to central registration and trial management software, increased physician and patient education of biomarker testing, as well as the global adoption of liquid biopsy technologies.
For treatment and monitoring, the barriers included inconvenient, expensive and time-consuming on-study visits, especially for people who are not close to large medical centers. The proposed strategy is to adopt COVID-19 approaches, which included the adoption of DCT and hybrid trials, adopting telemedicine technology for remote consent, toxicity monitoring and follow-up, local laboratory and imaging studies, and remote shipment of oral drugs to patients’ homes. They also push for the use of mobile devices such as pulse oximeters in the home.
The Coalition also urged trial participants and patients to be active partners rather than passive research subjects. In particular, they provided examples from the Rare Disease Clinical Research Network and The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation 2021 draft guideline that urged the incorporation of patients’ opinions in the early stages of clinical development via interviews and surveys.
Also, they emphasized the importance of enrolling a diverse patient population, including racial ethnic minorities, older adults and people from rural areas, as well as enrolling patients regardless of socioeconomic status. They suggested the use of artificial intelligence models to identify at-risk periods when patients need closer monitoring.
In terms of regulatory harmonization among international regulatory bodies, the Consortium found this to be the most consequential barrier. “Differences in requirements for regulatory approval may prevent effective international cooperation and dramatically slow development,” they wrote. “Separate submissions to different agencies create duplication of work and increase the cost of developing novel drugs.” In addition, there are legal and regulatory issues for telemedicine and remote monitoring within the U.S. as well as internationally.
The Consortium noted the U.S. Food and Drug Administration’s Project Orbis, which is an international collaboration among certain governments that allows for simultaneous submission and review of cancer therapies. The countries participating include the U.S., Canada, Australia, Singapore, Switzerland, Brazil, the UK and Israel. In its first year, Project Orbis received 60 cancer marketing applications in 16 unique projects and had 38 approvals.
They also note that China’s NMPA has approved several cancer products based on foreign data after joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (IOCH) in 2017. The European Union Clinical Trials Regulation went into effect on January 31, 2022, in an attempt to harmonize submission in one application instead of applications for each European Union member state individually.
In conclusion, the Coalition stated, “As cancer continues to take close to 10 million lives worldwide every year and devastate the families and loved ones of those affected, the goals outlined by the Coalition contribute toward a greater international movement in science in which every person has a role to play. From raising awareness and facilitating enrollment to optimizing treatment and monitoring, we encourage all cancer stakeholders to help advance patient-centric international trials by adopting principles of the proposed strategies from their unique perspectives and in their unique environments.”
And finally, they stated, “Such 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.”
