(Note: This post will appear in the Sept.-Oct. issue of Forbes China. Click here for more information about the 2020 Forbes China Healthcare Summit)
By Bob T. Li, MD and Sir Murray F. Brennan, MD
The COVID-19 pandemic has created the biggest public health crisis in a century, surpassing 20 million cases and 730,000 deaths worldwide by early August of 2020.1 Against this pandemic backdrop, there is a greater war against an enemy of humanity that is more relentless and lethal.
Cancer affects more than 18 million new individual lives and kills approximately 9.6 million people worldwide every year.2-3 Despite scientific advances in prevention and treatment leading to substantial improvements in survival since the U.S. National Cancer Act in 1971, the war on cancer is far from over. Most people have at least one family member or loved one afflicted by cancer and have witnessed the devastating impact on the lives of their family members, friends, and colleagues. Better methods of prevention and treatment are urgently needed.
International collaboration offers hope of winning the war on cancer. By sharing and combining knowledge, collaboration accelerates clinical trials and regulatory approvals of new prevention and treatment strategies. Clinical trials are the key to
translating scientific discovery to clinical practice, which saves lives. Traditionally this process takes 10 to 15-years, beginning with early phase trials, which determine safety and efficacy, followed by late phase trials, which define the benefit compared to current available treatments, and then finally onto often lengthy approval processes by governments and regulatory agencies.
The two biggest obstacles to conducting clinical trials are time and finding the right patients. Tumor mutations or molecular alterations that might be targeted by precision medicines may be extremely rare, often comprising as little as 1% of a specific cancer type. The time it takes to develop a cancer drug to market is critical for pharmaceutical companies, as every innovative drug typically faces patent protection expiry after 20 years. Drug development clinical trials are expensive, costing tens of millions of dollars, and most experimental drugs fail to reach the market.
International collaboration in clinical trials of precision medicines involving the U.S., China, Europe and elsewhere has helped accelerate this process by increasing the scale of patient accrual not possible in a single country. For example, international trials of osimertinib for lung cancer conducted in Asia, Europe and North America resulted in U.S. Food and Drug Administration (FDA) approval in less than 3 years – a record speed.4-5
The U.S. FDA recently launched Project Orbis, an initiative of international collaboration between government regulators for concurrent submission and review of new oncology products, potentially accelerating and optimizing clinical trials and cancer treatments in multiple countries.6 The first joint review under Project Orbis was conducted between the U.S. FDA, Australian Therapeutics Goods Administration, and Health Canada, allowing simultaneous regulatory decisions in three countries. The U.S. FDA has also initiated dialogue with government regulators of Europe, Switzerland, Japan, and China to discuss similar collaborations.
Clinical trials differ from basic laboratory research in that the investigational products are already patented with publicly available information. The trials are conducted in a highly transparent manner with designs and endpoints freely available on public registries such as clinicaltrials.gov. Funding is disclosed, whether it comes from the pharmaceutical and biotechnology industry, philanthropic foundations or government grants. The investigations are conducted under International Council of Harmonization Good Clinical Practice standards and ensure protection of patient privacy. Clinical trial conduct and data are subject to frequent audits and monitoring by contract research organizations and government regulators to ensure quality. Unlike preclinical research and development, clinical trials do not frequently trigger intellectual property concerns. Intellectual property protection is strengthened by the highly regulated and transparent clinical trial process.
With synergy across academia, industry, philanthropy and government regulators around the world, an unprecedented opportunity has emerged to accelerate the development of new prevention and treatment strategies that can cure or control cancers, perhaps within a generation.
Academic cancer centers play a leading role in initiating and ethically performing clinical trials to bring the latest scientific discoveries to patients. Memorial Sloan Kettering Cancer Center (MSK) based in New York City, is the world’s oldest and largest private cancer center which has been striving in its mission to conquer cancer for more than 135 years. As cancer physicians who came from the antipodes, and who have personally lost loved ones from cancer, we feel privileged to be serving the mission of this great American institution in bringing the world together to help win the war on cancer.
Note： Bob T. Li, MD is an Australian medical oncologist and drug development physician-scientist at Memorial Sloan Kettering Cancer Center (MSK). He is MSK’s Physician Ambassador to China and Asia-Pacific. Sir Murray F. Brennan, MD is an American and New Zealand surgical oncologist, scientist and Senior Vice President of International Programs at MSK, New York, USA.
1. Johns Hopkins University Coronavirus Resource Center. Available: https://coronavirus.jhu.edu/map.html
2. Siegel RL et al. Cancer statistics, 2019. CA Cancer J Clin. 2019
3. Bray F et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018
4. Mok T et al. N Engl J Med. 2017; 376:629-640
5. U.S. Food and Drug Administration. Osimertinib (Tagrisso). Available: https://www.fda.gov/drugs/resources-information-approved-drugs/osimertinib-tagrisso
6. U.S. Food and Drug Administration. Project Orbis. Available: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis