New Consensus Paper Published in Nature Medicine
Asia Society
April 19, 2022
East-West collaboration argues that post-pandemic, telemedicine and remote monitoring can deliver better cancer treatment and care to underserved populations
The Bloomberg New Economy International Cancer Coalition (the “Coalition”) today called for a permanent paradigm change in the way cancer patients are diagnosed, treated and cared for across the globe.
In a commentary piece published today in Nature Medicine, the Coalition demonstrates that the COVID-19 pandemic upended the infrastructure and delivery of oncology clinical trials worldwide and that technologies such as
- telemedicine,
- improved diagnostic capabilities, and
- remote monitoring have
huge potential and should be better harnessed to become more broadly used for clinical trials in the future.
In an effort to allow potentially lifesaving experimental therapies for patients to continue during the pandemic, government regulators, medical centers, and clinical trial sponsors implemented unprecedented flexibilities in clinical trial conduct.
The U.S. Food and Drug Administration (FDA), along with regulatory agencies from China, Russia, the European Union, Brazil, Australia and Nigeria, separately issued guidance that was adopted by their respective regions which provided new opportunities to optimize the patient experience, and, illuminated how digital technology and collaboration may improve access, alleviate patient burden, and increase the diversity of participants, including those in remote and disadvantaged communities.
“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 U.S. Food and Drug Administration’s (FDA) 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 was formed explicitly to explore ways to drive better access and international collaboration to clinical trials, while also encouraging regulatory harmonization that would accelerate the development of novel cancer treatments, screening, and prevention.
The Coalition is comprised of leaders from academic medical centers, government regulatory agencies, the pharmaceutical and biotechnology industry, contract research organizations, patient advocacy groups and policy think tanks.
It 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).
In the commentary piece, the Coalition recommends three areas of focus to move forward a new model of cancer care.
- 1.Patient identification and enrollment: leveraging hub and spoke networks
- 2.Treatment and monitoring: enhancing remote and hybrid models
- 3.Regulatory harmonization: lowering barriers to patient-centric care across the globe
1.Patient identification and enrollment: leveraging hub and spoke networks
The Coalition highlights some of the barriers facing patient enrollment including:
- 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, of which the physician might have minimal knowledge.
The Coalition argues that information technology tools should be part of the solution to overcoming many of these barriers.
It envisions building towards an interactive international database 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.
It envisions building towards an interactive international database … 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 network where academic or large community cancer centers serve as a hub for distributed clinical research sites in the wider community.
A hub-and-spoke network is widely implemented in the management of acute stroke and myocardial infarction and could be further facilitated in accrual efforts through technological innovations such as remote consent.
“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 MSK, and lead author on the new Nature Medicine piece.
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 in the wider community.
A hub-and-spoke network is widely implemented in the management of acute stroke and myocardial infarction …
“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.”
It has been demonstrated that when eligible patients are offered a trial, they consent more than 50% of the time.
2.Treatment and monitoring: enhancing remote and hybrid models
Given the often arduous on-study visits required by oncology clinical trials, sometimes involving procedures such as imaging and biopsies, on-protocol treatment is inconvenient, costly and time-consuming, creating a barrier for patients who lack the time and means necessary to participate.
This is especially true for patients who live at a distance from the large medical centers that conduct most such protocols.
In the U.S., nearly half of patients with 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 geographic disparities are seen globally.
The COVID-19 pandemic has led research teams to re-examine the need for in-person visits and 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.
With effective coordination, clinical trials could be broadened to engage local physicians’ practices, pharmacies, or patients’ homes for mobile phlebotomy where data could be transmitted online.
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.
With effective coordination, 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.”
3.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 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.
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 nine days of review.
- The European Union Clinical Trials Regulation came into effect on January 31, 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.”
“Cancer’s toll knows no borders, and when it comes to fighting it, neither can we,”
The following Coalition members authored the paper:
- Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, New York, USA
- Princess Margaret Cancer Center, University of Toronto, Toronto, Ontario, Canada
- Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
- Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
- Massachusetts General Hospital Cancer Center, Boston, MA, USA
- Society for Translational Oncology, USA
- Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA
- Cancer Support Community, USA
- Foundation Medicine, MA, USA
- Novartis, Switzerland
- PPD, Inc, USA
- Resolution Bioscience, Agilent Technologies, USA
- McKinsey Cancer Center, McKinsey & Company
- Bloomberg New Economy Forum, New York, NY, USA
- Asia Society, New York, NY, USA
- Daiichi Sankyo, Japan
- Innovent Biologics, China
- The Janssen Pharmaceutical Companies of Johnson & Johnson, USA
- BeiGene, China
- Zai Lab, China
- Amgen, USA
- Genentech, USA
- Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA
- Jiangsu Hengrui Medicine, China
- Bayer AG, Germany
- Shanghai TuoXin Health Promotion Center, China
- CEO Roundtable on Cancer, USA
- Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Chinese Thoracic Oncology Group, Guangzhou, China
About The Bloomberg New Economy International Cancer Coalition
Co-chaired by Kevin Rudd, President and CEO of the Asia Society and former Prime Minister of Australia and Stefan Oelrich, Member of the Board of Management of Bayer AG and President Pharmaceuticals,
The International Cancer Coalition is composed of CEOs and senior representatives from the leading global pharmaceutical, biotech and diagnostic companies, senior representatives from regulatory bodies, and researchers and academics from major cancer centers and universities worldwide.
REFERENCE PUBLICATION
Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition
Nature Medicine
Bob T. Li, Bobby Daly, Mary Gospodarowicz, Monica M. Bertagnolli, Otis W. Brawley, Bruce A. Chabner, Lola Fashoyin-Aje, R. Angelo de Claro, Elizabeth Franklin, Jennifer Mills, Jeff Legos, Karen Kaucic, Mark Li, Lydia The, Tina Hou, Ting-Hui Wu, Bjorn Albrecht, Yi Shao, Justin Finnegan, Jing Qian, Javad Shahidi, Eduard Gasal, Craig Tendler, Geoffrey Kim, James Yan, Phuong Khanh Morrow, Charles S. Fuchs, Lianshan Zhang, Robert LaCaze, Stefan Oelrich, Martin J. Murphy, Richard Pazdur, Kevin Rudd & Yi-Long Wu
The Bloomberg New Economy International Cancer 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.
The COVID-19 pandemic upended the infrastructure and delivery of oncology clinical trials worldwide.
In an effort to allow potentially lifesaving experimental therapies for patients to continue during the pandemic, government regulators, medical centers and clinical trial sponsors implemented unprecedented flexibilities in the conduct of clinical trials1. The US Food and Drug Administration (FDA), along with regulatory agencies from China, Russia, the European Union, Brazil, Australia and Nigeria, separately issued guidance that was adopted in their respective regions (Table 1).
These measures provided new opportunities to optimize the patient experience and illuminated how digital technology and collaboration may improve access, alleviate patient burden and increase the diversity of participants, including those in remote and disadvantaged communities.
To convert these improvements into a permanent paradigm change after the pandemic, a coordinated, global multi-stakeholder effort is required. In the spring of 2021, Bloomberg New Economy, Bloomberg LP’s media and event platform tasked with advancing solutions to shared global challenges, launched the Bloomberg New Economy International Cancer Coalition. This initiative emerged from discussions on East–West collaboration between global leaders and experts at the 2019 Bloomberg New Economy Forum in Beijing. The Coalition gathered leaders from academic medical centers, government regulatory agencies, the pharmaceutical and biotechnology industry, contract research organizations, patient advocacy groups and policy think tanks to identify barriers and solutions that their respective institutions may cohesively act upon for worldwide impact (Table 2).
The members of the Coalition have been convening regularly since July 2021 to explore ways to achieve better access to clinical trials and regulatory harmonization that will accelerate the development of novel cancer treatments, screening and prevention.
The priorities of the Coalition were determined by means of an electronic voting system during the convening. The top three proposed actions that received the highest vote counts in each of three categories — patient identification and enrolment, treatment and monitoring, regulatory harmonization — were carried forward as recommendations.
Patient-centric trials are defined as investigations that prioritize the needs of the patient at all stages, including design, activation, enrollment, data collection, completion and outcome reporting.
In patient-centric trials, hypotheses that are important to patients can be formulated, study designs that minimize burden to patients can be employed, …
… and measures that ensure that trial conduct and data generation are regulatory compliant and support potential improvement to the standard of care can be implemented.
Technologies such as telemedicine and remote monitoring that were necessitated during COVID-19 pandemic lockdowns may become more broadly used for clinical trials in the future.
Technologies such as telemedicine and remote monitoring that were necessitated during COVID-19 pandemic lockdowns may become more broadly used for clinical trials in the future.
There is now an opportunity to leverage cross-border regulatory efforts to harmonize the standards for conducting patient-centric trials …
… by focusing on the barriers patients typically face when seeking a clinical trial and presenting actionable solutions to overcoming these barriers over a 5-year horizon. Fig. 1
There is now an opportunity to leverage cross-border regulatory efforts to harmonize the standards for conducting patient-centric trials …
Fig. 1: Patient-centric cancer clinical trials improve access, diversity and accelerate breakthroughs.
Patient-centric care may be achieved
- by reducing barriers to trial participation,
- by leveraging technologies such as telemedicine, remote monitoring and liquid biopsy, and
- by international collaboration including regulatory harmonization.
1.Patient identification and enrollment: leveraging hub and spoke networks
Barriers
For decades, recommendations from the National Comprehensive Cancer Network in the United States and other national and international oncology societies have stated that
… the best management of any patient with cancer is a clinical trial, …
… yet in the United States, for example, only 2–8% of such patients are enrolled in trials2,3.
One key barrier is the lack of integration of patient care and clinical research, particularly in underserved communities.
Patient enrollment into trials requires clinicians’ familiarity with both open protocols and the minutia of their eligibility requirements4.
This is increasingly challenging for practitioners because trials have grown in complexity, with a greater number of screening procedures and more stringent eligibility criteria, much of it biomarker specific, in which molecularly targeted therapies of rare tumor mutations are sought.
A survey of 2,000 healthcare providers revealed that approximately 70% are interested in referring patients to clinical trials; however, they lack sufficient information, as well as the time to identify, evaluate and confidently discuss clinical trial options with their patients5.
… the best management of any patient with cancer is a clinical trial, …… yet in the United States, for example, only 2–8% of such patients are enrolled in trials2,3.
Inequitable access to biomarker testing and next-generation sequencing (NGS) adds another layer of challenges for trial access even when clinicians are aware of trials.
- Patients lack understanding of clinical trials, and
- not all patients are systematically asked to participate, resulting in a lack of diversity in clinical trial participants.
- In addition, overly restrictive inclusion/exclusion criteria further limit trial participation and the generalizability of trial data to real-world populations.
Once a patient is identified and expresses interest, trial availability in the local area remains a major barrier as many trials are limited to academic medical centers.
In the United States, 74% of patients with cancer receive treatment in the community, and a recent study found that no trials were offered in 36% of physician-owned practices4,6.
In China, although clinical trial sites are rapidly increasing (to over 1,000 in 2020 versus only 300 in 2015), most sites still lack experience, as less than 30% conducted more than 20 trials between 2019 and 20207.
For many patients to participate in a trial, their local oncologist must advise and refer them to trials conducted at other institutions, of which the physician might have minimal knowledge.
In addition, accomplishing this referral is costly to the practitioner given the administrative support needed to coordinate the transfer of care to another facility and the associated loss of revenue.
Proposed strategy
Innovations in information technology should be part of the solutions to overcoming many of these barriers.
Specifically, with clinical information entered appropriately into an electronic health record during routine care, the central registration and trial management software can systematically identify patients and match them to particular trials based on the molecular features of their tumors and other eligibility criteria4.
Efforts should also be put toward increasing awareness of biomarker testing through physician and patient education, as well as decreasing barriers to access through infrastructure improvement and the adoption of new technology.
The global adoption of liquid biopsy technologies in plasma circulating tumor DNA analysis, which may be performed in local pharmacies or at patients’ homes through mobile phlebotomy, can broaden access to molecular profiling and may soon be used to identify potentially lifesaving matched therapies8.
The Coalition envisions building toward an interactive international database into which patients with cancer may elect to enter at diagnosis and to which data may be added over time, including digital pathology reports and molecular profiles.
Maintaining data provenance across multiple care sites could be achieved if each patient receives a global ID. Privacy under these conditions could be maintained by allowing the patient, if they wish, to hold the key to decrypting of their data and identification.
A trial sponsor could then screen consolidated databases, using matching software, and notify patients and their oncologists if an appropriate protocol is available9,10.
Secure public data-sharing strategies already exist11, and private technology companies are rapidly entering the clinical trials matching space, but the Coalition encourages a global, public-private partnered or collaborative effort to ensure that all patients have the opportunity to register.
As much as possible, the goal is to bring the trial to the patient, maintaining established clinician-patient relationships of trust.
Once patients are matched to trials, enrollment could be managed by a hub-and-spoke network in which academic or large community cancer centers serve as a hub for distributed clinical research sites in the wider community.
A hub-and-spoke network is widely implemented in the management of acute stroke and myocardial infarction and could be further facilitated in trial participant accrual efforts through technological innovations such as remote consent12.
A hub-and-spoke network is widely implemented in the management of acute stroke and myocardial infarction and could be further facilitated in trial participant accrual efforts through technological innovations such as remote consent12.
The network would need to extend services into communities with the greatest unmet needs and strengthen clinical trial education of in-network healthcare professions to foster the integration of patient care and clinical research.
Promoting the concept of patient-centric care, this network model would ensure that trials are 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 time3.
The Alpha-T trial serves as an example of such a decentralized clinical trial in which the trial sites are patients’ homes ( NCT04644315).
Trial eligibility criteria should be more inclusive of real-world populations, especially in regard to laboratory cutoffs, as this approach has been shown to more than double the eligible patient population without compromising safety13.
We must do better in improving patients’ access to potentially lifesaving clinical trials.
We must do better in improving patients’ access to potentially lifesaving clinical trials.
2.Treatment and monitoring: enhancing remote and hybrid models
Barriers
Given the often arduous on-study visits required by oncology clinical trials, sometimes involving procedures such as imaging and biopsies, on-protocol treatment is inconvenient, costly and time-consuming, creating a barrier for patients who lack the time and means necessary to participate.
This is especially true for patients who live at a distance from the large medical centers that conduct most such protocols.
In the United States, nearly half of patients with metastatic breast, prostate, colorectal and non-small-cell lung cancers need to drive more than 60 minutes each way to access a clinical trial site14.
Such geographic disparities exist globally: a systematic review of clinical trials of cancer drugs in China found that the majority of clinical trial units are in eastern coastal China (41%), with only 3% in southwest inland China15.
There is room to improve trial accessibility by minimizing geographic disparities and travel burden, as many in-person visits required by traditional protocols do not produce data leading to clinical interventions but rather are used for regulatory purposes to establish safety.
There is room to improve trial accessibility by minimizing geographic disparities and travel burden, as many in-person visits required by traditional protocols do not produce data leading to clinical interventions but rather are used for regulatory purposes to establish safety.
A study at MD Anderson Cancer Center in Texas showed that 8,518 electrocardiograms in 525 patients in phase I trials provided no clinically significant information16.
Although there may be value in monitoring the cardiac effects of novel drugs, remote technologies with wireless sensors may deliver accurate real-world data from patients’ homes.
Although there may be value in monitoring the cardiac effects of novel drugs, remote technologies with wireless sensors may deliver accurate real-world data from patients’ homes.
Proposed strategy
The COVID-19 pandemic has led research teams to re-examine the need for in-person visits and 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.
These measures were adopted in the international phase I/II CodeBreaK100 trial of sotorasib, which was conducted largely in midst of the pandemic and delivered FDA approval of the first KRAS inhibitor17,18.
In addition, ongoing novel studies in oncology, such as the ON TRAX trial ( NCT04381494), are collecting data from mobile devices such as pulse oximeters in the home to identify toxicities such as pneumonitis, with the hope of early detection and intervention to improve outcomes.
In addition, ongoing novel studies in oncology, such as the ON TRAX trial ( NCT04381494), are collecting data from mobile devices such as pulse oximeters in the home to identify toxicities such as pneumonitis, with the hope of early detection and intervention to improve outcomes.
With effective coordination, clinical trials could be broadened to utilize local physicians’ practices, pharmacies or patients’ homes for mobile phlebotomy, with data transmitted online.
For example, in Brazil a protocol provided for at-home testing to check patients for cancers with epidermal growth factor receptor (EGFR) mutations.
For example, in Brazil a protocol provided for at-home testing to check patients for cancers with epidermal growth factor receptor (EGFR) mutations.
In addition, to enable a truly patient-centric trial, patients should not be passive research subjects but rather active partners, with their perspectives and needs integrated to help review protocols, design and implement trials, and disseminate findings19.
More than 80% of the research consortia in the Rare Disease Clinical Research Network reported patient groups reviewing protocols and providing input on study design20.
There is potential to leverage a similar model to drive patient-centric oncology trials.
In China, a similar effort has taken place recently.
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation 2021 draft guideline emphasizes the importance of incorporating patients’ voice at early stages of clinical development through interviews and surveys.
In addition, the draft guideline highlights that patient burden should be reduced to the greatest extent possible during the trial without compromising safety or data quality; telemedicine, wearable medical equipment, and remote research drug shipment should be considered.
In addition, the draft guideline highlights that patient burden should be reduced to the greatest extent possible during the trial without compromising safety or data quality; telemedicine, wearable medical equipment, and remote research drug shipment should be considered.
It will be critical to enroll a diverse patient population, including racial ethnic minorities, older adults and those from rural areas, and to enroll patients regardless of socioeconomic status, …
… to address disparities in trial participation and ensure that the on-protocol procedures and visits advance research objectives without creating unnecessary burdens for patients.
After evaluating more than 90 trial protocols through the lens of patient burden, one analysis concluded that up to 70% of patient data could be collected remotely through virtual visits and noninvasive data collection.
Artificial intelligence models that utilize remote monitoring and clinical data could also be adopted to identify at-risk periods when patients need closer monitoring21,22.
… up to 70% of patient data could be collected remotely through virtual visits and noninvasive data collection.
Artificial intelligence models that utilize remote monitoring and clinical data could also be adopted to identify at-risk periods when patients need closer monitoring
In addition, it will be important to conduct truly multi-regional trials that reflect the population across regions while also ensuring that the study results are applicable to the patients expected to use the drugs once approved23.
The Coalition thus concludes that there are currently multiple opportunities to broaden trial access by scrutinizing and amending protocols to ensure that appropriate care is delivered when, where and by the means most convenient to the patient.
In addition, it will be important to conduct truly multi-regional trials that reflect the population across regions while also ensuring that the study results are applicable to the patients expected to use the drugs once approved23.
The Coalition thus concludes that there are currently multiple opportunities to broaden trial access by scrutinizing and amending protocols to ensure that appropriate care is delivered when, where and by the means most convenient to the patient.
3.Regulatory harmonization: lowering barriers to patient-centric care globally
Barriers
Lack of harmonization among international regulatory policies presents the most consequential barrier in worldwide efforts to develop novel strategies for cancer treatment and prevention24.
Differences in requirements for regulatory approval may prevent effective international cooperation and dramatically slow development.
Separate submissions to different agencies create duplication of work and increase the cost of developing novel drugs.
There is also currently no international diagnostics standard for cancer molecular profiling, which will be crucial to enable patient-centric global trials matching.
Regulatory restrictions on international sharing of cancer genetics data may also prevent translational science discoveries and impede early-phase development of novel drugs.
Finally, legal and regulatory policy to guide telemedicine and remote monitoring are lacking both domestically within the United States and internationally, and it is currently unknown whether the changes in guidance and reimbursement for telemedicine will continue if the current public health emergency subsides.
Lack of harmonization among international regulatory policies presents the most consequential barrier in worldwide efforts to develop novel strategies for cancer treatment and prevention2
Proposed strategy
The US FDA has initiated Project Orbis, an international collaboration among government regulatory agencies for the simultaneous submission and review of new oncology products, currently consisting of the United States, Canada, Australia, Singapore, Switzerland, Brazil, the United Kingdom and Israel.
In the first year, Project Orbis received 60 oncology marketing applications in 16 unique projects and resulted in 38 approvals25.
Patients in participant countries benefit from early access to ground-breaking therapies such as osimertinib and sotorasib, which were both developed from first-in-human dosing to FDA approval in record periods of less than 3 years17,18,26,27.
In addition, 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 review28.
More recently, 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 requiring applications to each European Union member state individually.
These examples demonstrate how international collaboration and regulatory harmonization could deliver sheer scale of data and population to accelerate the development of cancer cures and prevention, and thus bring innovative medicines to more patients faster.
These examples demonstrate how international collaboration and regulatory harmonization could deliver sheer scale of data and population to accelerate the development of cancer cures and prevention, and thus bring innovative medicines to more patients faster.
A new paradigm post pandemic
After defining the priorities of patient-centric trials, the Coalition is promoting “intentional implementation” across clinical trial stakeholders and government agencies.
To date, Coalition members have agreed upon actions by their respective institutions:
- pharmaceutical industry and academic medical centers commit to adopting technologies in clinical trial protocols to improve patient access and diversity, removing barriers to trial participation;
- diagnostic companies commit to developing digital solutions to match trials to diverse patient communities, especially in underserved areas, to accelerate trial enrollment;
- regulatory authorities commit to expanding their existing cross-regional efforts on regulatory harmonization to avoid redundancy and filing delays;
- patient advocacy groups and nonprofit organizations commit to empowering patients through education and helping them contribute unique insights to trial designs that are equitable and patient-centric.
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 own unique perspectives and in their own unique environments.
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.
The Bloomberg New Economy International Cancer Coalition, as a part of the wider Bloomberg New Economy initiative, is supported by its Knowledge Partner McKinsey & Company, by select corporate sponsors (Bayer, Dangote, ExxonMobil, HSBC, Hyundai, Mastercard, Tata and Vanke, at the time of writing) and by Bloomberg Media, a business unit of Bloomberg L.P. B.T.L. and B.D. are supported by the Comprehensive Cancer Center Core Grant (P30 CA008748) at Memorial Sloan Kettering Cancer Center from the US National Institutes of Health.
Authors and Affiliations
Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, New York, NY, USA
Bob T. Li & Bobby Daly
Princess Margaret Cancer Center, , University of Toronto, Toronto, Ontario, Canada
Mary Gospodarowicz
Dana-Farber Brigham Cancer Center, Harvard Medical School, Boston, MA, USA
Monica M. Bertagnolli
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
Otis W. Brawley
Massachusetts General Hospital Cancer Center, Boston, MA, USA
Bruce A. Chabner
Society for Translational Oncology, Durham, NC, USA
Bruce A. Chabner & Martin J. Murphy
Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA
Lola Fashoyin-Aje, R. Angelo de Claro & Richard Pazdur
Cancer Support Community, Washington, DC, USA
Elizabeth Franklin
Foundation Medicine, Inc., Cambridge, MA, USA
Jennifer Mills
Novartis, Basel, Switzerland
Jeff Legos
PPD, Inc., Wilmington, NC, USA
Karen Kaucic
Resolution Bioscience, Agilent Technologies, Kirkland, WA, USA
Mark Li
McKinsey Cancer Center, McKinsey & Company https://www.mckinsey.com/
Lydia The, Tina Hou, Ting-Hui Wu, Bjorn Albrecht & Yi Shao
Bloomberg New Economy, Bloomberg L.P., New York, NY, USA
Justin Finnegan
Asia Society Policy Institute, Asia Society, New York, NY, USA
Jing Qian & Kevin Rudd
Daiichi Sankyo, Tokyo, Japan
Javad Shahidi
Innovent Biologics, Suzhou, China
Eduard Gasal
Janssen, Johnson and Johnson, New Brunswick, NJ, USA
Craig Tendler
BeiGene USA, BeiGene, Beijing, China
Geoffrey Kim
Zai Lab, Shanghai, China
James Yan
Amgen, Inc, Thousand Oaks, CA, USA
Phuong Khanh Morrow
Genentech, South San Francisco, CA, USA
Charles S. Fuchs
Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA
Charles S. Fuchs
Jiangsu Hengrui Pharmaceuticals, Shanghai, China
Lianshan Zhang
Bayer AG, Leverkusen, Germany
Robert LaCaze & Stefan Oelrich
Shanghai TuoXin Health Promotion Center, Shanghai, China
Martin J. Murphy
CEO Roundtable on Cancer, Morrisville, NC, USA
Martin J. Murphy
Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Chinese Thoracic Oncology Group, Guangzhou, China
Yi-Long Wu
Contributions
B.T.L., B.D. and T.-H.W. wrote the initial draft; all authors provided comments and reviewed the final manuscript.
Originally published at https://www.nature.com on April 19, 2022.
