A new global coalition of comprising healthcare providers, pharmaceutical companies, diagnostics developers, and researcher organization have provided a blueprint for a new method of how cancer patients are diagnosed and treated around the world. Named the Bloomberg New Economy International Cancer Coalition, the new body demonstrates in a commentary published Tuesday in Nature Medicine that technologies such as telemedicine, improved diagnostic capabilities, and remote monitoring have significant potential and should be better harnessed for clinical trials in the future.
The COVID-19 pandemic had far reaching effects on the conduct of clinical trials, which in most locations around the world were halted in early 2020 as the extent of the health crisis became apparent. When clinical trials resumed, countries and regulatory agencies around the world issued guidance for the safe conduct of clinical studies, most of which were intended to minimize person-to-person contact or situations that could potential put study participants at risk of contracting the virus. Most of the measures leaned heavily on remote management of trial participants where once in-person visits were required. These new, unprecedented flexibilities in clinical trial conduct were necessary during the pandemic, but also pointed to ways to revamp clinical trials in ways that could make the potentially life-saving medicines available to populations that previously did not have access to them
“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, director of the FDA’s Oncology Center of Excellence (OCE), a member of the coalition, and an author on the new Nature Medicine piece. “Achieving broader diversity across clinical trials is a key priority for the FDA and finding ways to lower barriers for patients to benefit from trials is necessary both here and abroad.”
The coalition launched virtually in Spring 2021 and in-person at the Bloomberg New Economy Forum in Singapore with founding partners including Asia Society and Memorial Sloan Kettering Cancer Center (MSK).
The coalition recommends three areas of focus to move torward a new model of cancer care.
Patient identification and enrollment: leveraging hub and spoke networks
In looking toward a future with broader access to clinical trials, the coalition identified barriers to greater access. These include healthcare providers lacking sufficient information and the time to identify, evaluate, and confidentially discuss clinical trial options with their patients; inequitable access to biomarker testing and next generation sequencing (NGS), including liquid biopsy and overly restrictive upfront inclusion/exclusion criteria.
Limited trial availability in a patient´s local area is also a major stumbling block. Many trials are only limited to academic medical centers. In the U.S. 74% of patients receive treatment in their communities, and for many patients to participate in a trial, their local oncologist must advise and refer them to trials conducted at other institutions, often hundreds of miles away, and of which the physician might have minimal knowledge.
To overcome this barrier, the coalition urges the adoption of new tools that could help build an international in which patients with cancer may elect to enter at diagnosis and data may be added over time, including digital pathology and molecular profile. Maintaining data provenance across multiple care sites could be achieved if each patient receives a global ID.
Once patients are matched to trials, enrollment could be managed by a hub-and-spoke similar to those employed in the management of acute stroke and myocardial infarction patients, that relies on academic or large community cancer centers serving as hubs for distributed clinical research sites in the wider community.
“The goal is to bring the trial to the patient, maintaining established clinician-patient relationships of trust,” said Bob Li, medical oncologist and physician ambassador to China and Asia-Pacific at Memorial Sloan Kettering, and lead author of the Nature Medicine piece.
“Promoting the concept of patient-centric care, this network model would ensure that trials are being offered to patients regardless of where they live. It has been demonstrated that when eligible patients are offered a trial, they consent more than 50% of the time. We must do better by improving patients’ access to potentially lifesaving clinical trials.”
Treatment and monitoring: enhancing remote and hybrid models
Currently, in the U.S., close to half of the patients enrolled in clinical studies for metastatic breast, prostate, colorectal, and non-small cell lung cancers need to drive more than 60 minutes each way to access a clinical trial site. Such challenges are not limited to the U.S., but are present around the world. The travel time required for in-person visits for centralized trials, and the associated costs present a barrier to participation for many patients who might otherwise qualify for a clinical trial.
The pandemic caused researchers to re-examine the need for in-person visits, which significantly accelerated the adoption of remote and hybrid trials. Clinical trials have adopted telemedicine technology for remote consent, toxicity monitoring and follow up, local laboratory and imaging studies and remote shipment of oral medicines to patients’ homes. Using what has been learned from the necessary re-designing of clinical trials in the face of the pandemic, the coalition urges that clinical trials could be broadened to engage local physicians’ practices, pharmacies, or patients’ homes for mobile phlebotomy where data could be transmitted online.
“To accelerate the eradication of cancer, we need multi-stakeholder, multi-regional collaboration, to promote both patient-centric clinical trials and international regulatory harmonization,” said Kevin Rudd, president and CEO of the Asia Society and former Prime Minister of Australia. “This would not only provide global public goods by building the policy, scientific, and technological infrastructure for international public health collaboration, but could also become the new ping-pong diplomacy between the U.S. and China.”
Regulatory harmonization: lowering barriers to patient-centric care across the globe
The Coalition concludes 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 currently 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.
The coalition cites three examples that demonstrate the potential benefits of international collaboration and regulatory harmonization:
- The U.S. FDA-initiated Project Orbis – an international collaboration among government regulatory agencies for simultaneous submission and review of new oncology products, currently consisting of the U.S., Canada, Australia, Singapore, Switzerland, Brazil, the United Kingdom, and Israel.
- China’s NMPA has approved several oncology products based on foreign data after joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017, including the 9-valent HPV vaccine against cervical cancer after only 9 days of review
- The European Union Clinical Trials Regulation came into effect on 31 January 2022 in an effort to harmonize submissions in a single application instead of applying to each European Union member
“Cancer’s toll knows no borders, and when it comes to fighting it, neither can we,” said Michael R. Bloomberg, founder of Bloomberg LP and Bloomberg Philanthropies. “We’re making important strides in prevention and treatment, and the more partners we can bring together from around the world, the more lives we can save.”
