New Report | Advancing Global Health Equity: Enhancing Clinical Trials Access and Cooperation to Save Millions of Lives from Cancer | Asia Society

New Report | Advancing Global Health Equity: Enhancing Clinical Trials Access and Cooperation to Save Millions of Lives from Cancer

NEW YORK; November 1, 2023 – If China were to join the U.S.-led cancer research project Cancer Moonshot and its core initiative Project Orbis, the time needed to roll out new cancer treatments globally would significantly shorten, potentially turning a 10-15-year process into a 2-3 year process, and the number of new cancer cases represented amongst its members would rise from 21.64% to 46.88%, a new report from the Asia Society Policy Institute’s Center for China Analysis (CCA) argues.

“Advancing Global Health Equity: Enhancing Clinical Trials Access and Cooperation to Save Millions of Lives from Cancer” explores the regulatory landscape and pathways for enhancing international cooperation in the fight against cancer, honing in on the benefits and challenges of China joining Project Orbis as a case study. It is the first report by the CCA’s Cure4Cancer Task Force, co-authored by a group of 17 top physicians and researchers involved in Center’s broader Cure4Cancer initiative.

Many of the 10 million lives lost each year to cancer could be saved through enhanced international cooperation. Global regulatory harmonization for clinical trials and cancer therapy approvals could significantly shorten the time needed to roll out new cancer treatments globally, potentially turning a 10-15-year process into a 2-3-year process, as well as reducing world-wide cancer-related deaths by an estimated 10-20%, or 1 to 2 million lives per year, according to prior research from the Cure4Cancer Coalition.

Project Orbis is an attempt to set up the international regulatory infrastructure needed to help achieve this. It establishes a unified system for simultaneous submission, review, regulatory action, and approvals of clinically significant new cancer treatments across its member countries, which currently include Canada, Australia, Switzerland, Singapore, Brazil, the U.K. and Israel.

Together, participating countries currently account for only 21.64% of new cancer cases worldwide in 2020 – hardly representative of the vast global cancer population, leaving shortcomings in the timeliness, diversity, and equity of the programs it supports for approval.

The quantity of data available to global researchers in China, with the world’s highest cancer patient population, is simple unavailable anywhere else. If China were to join Project Orbis, the number of new cancer cases represented amongst its members would rise from 21.64% to 46.88%.

Other benefits from China joining Project Orbis would include:

  • Standard setting: Given China’s patient population and market size, the global community is better served by including Chinese regulatory agencies, cancer researchers and doctors in the international standard-setting process.
  • Urgency: China (4.8 million new cases and 3.2 million deaths annually) and the U.S. (1.9 million new cases and 600,000 deaths annually) are the world’s No. 1 and No. 2 cancer hotspots.
  • Reducing costs for all: Project Orbis is proven to minimize lag times between FDA approval of innovative drugs and approval in other member countries. More data and lower regulatory hurdles translate directly into faster clinical trials and could lower R&D costs, in turn making approved treatments more affordable.
  • Reciprocity: U.S. and international biopharmaceutical companies would benefit from a reduction in lag time for drug approvals in China and faster entry into the China market. Communication between academic centers would increase.
  • Global multilateral leadership: China’s participation could pave the way for other countries to join, creating a snowball effect of further advancing the harmonization of international regulations and speeding up clinical trials.
  • Innovation and impact on the industry: Other countries could benefit from Chinese R&D through co-development. China's involvement in Project Orbis can also enhance the return on clinical trials and investment opportunities through diverse approval frameworks and faster timelines, if achieved.
  • Stabilize U.S.-China relationship and promote world peace: Opportunities for genuine U.S.-China cooperation today are rare, but both countries have a strong national interest in reducing cancer’s death toll.

The report also comprehensively addresses potential obstacles and opposition to China’s joining Project Orbis point by point, discussing concerns related to: biosecurity and human genetics, intellectual property protections, data quality and manipulation, LCA and process slowdown, and strategic competition and geopolitics.

Given the overwhelming benefits of having China join Project Orbis, the report authors recommend that policymakers work towards the signing of a limited confidentiality agreement (LCA) between the U.S. and China, a key milestone that would facilitate China’s entry. Beyond this specific case, the report also presents alternative strategies, cases, and feasible methods to foster robust and inclusive international cooperation in the fight against cancer – the common enemy of humanity. 

Greg Simon, Former President of the Biden Cancer Initiative and Distinguished Fellow for Global Public Health, Center for China Analysis, Asia Society Policy Institute; said: “This is an exceptionally well-written and well-reasoned report. It follows a logical arc in answering the most expected questions and presents layered arguments for the various branches of questions.  Obviously, I support the arguments in the paper but even a skeptic would have to admit these are compelling arguments. It is impressively easy to follow on a topic where most readers will not know as much as the author.  And most importantly, it presents the case for making saving lives the key operational goal in U.S-China relations in medical research without using a bludgeon to do so.”  

Co-author Bob T. Li, MD, PhD, MPH, medical oncologist at Memorial Sloan Kettering Cancer Center and Physician Ambassador to China and Asia-Pacific., said: "It is unacceptable and unsustainable that fewer than 5% of patients with cancer can access a clinical trial globally. International collaboration advances global health equity by expanding access to clinical trial participation, which shortens the oncology research and development timeline, reduces cost, and ultimately helps to accelerate the cure for cancer. This is a multi-stakeholder international movement that cannot be limited to any single institution or country, and everyone has a role to play in increasing public awareness, promoting cooperation and advancing patient-centric clinical trials."

Co-author Jing Qian, Co-Founder and Managing Director of the Asia Society Policy Institute’s Center for China Analysis, said: “Cancer, an indiscriminate foe, knows no borders, claiming 10 million lives annually. Both the U.S. and China, experiencing the devastating toll of this disease, emerge as natural allies in this battle. While the U.S. excels in biotech and regulatory frameworks, China’s unparalleled patient data and infrastructure make for an ideal collaboration. Together, streamlining global regulations and enhancing clinical trial enrollments can save 1-2 million lives every year. Just as the U.S. and the Soviet Union once united against smallpox during the Cold War’s height, the U.S. and China can work together in a similar spirit. And we have a historic opportunity in front of us, when the two leaders to meet in San Francisco in the middle of this November, to join forces against cancer. This isn’t just a win for both nations; it’s a win for humanity. In the face of adversity, this report helps us to write a story of hope, unity, and a shared future.”

Download the full report here, and learn more by visiting https://cure4cancerglobal.org/.

To speak with Jing Qian or any of our other experts at Asia Society Policy Institute please reach out to [email protected]. To speak with Dr. Bob Li at Memorial Sloan Kettering Cancer Center, please reach out to [email protected].

Cure4Cancer Initiative

Cure4Cancer (C4C) is an international movement that brings together patients, clinicians, scientists, policymakers, regulators, industry leaders, philanthropists, the media, and other closely related stakeholders in the global fight against cancer. The international movement is sustained through multi-stakeholder collaboration and cross-pollination among its global partners; thus, it cannot be limited to any single institution or country.

Its mission is to accelerate the development of cancer cures and prevention through increased public awareness, cooperation, and regulatory harmonization on patient-centric international clinical trials.

The Asia Society Policy Institute is the movement’s policy research and operational arm. Other partners include Memorial Sloan Kettering Cancer Center (MSK), Bloomberg New Economy International Cancer Coalition.

This is the first Cure4Cancer report of a series that will study global health equity in other countries and regions including Australia and New Zealand, Southeast Asia, South Asia, the Middle East, Africa, and Latin America – as no country or region is spared the burden of cancer. This first report will provide readers with a background on international cancer trials and show how the first case study on China, the country with the greatest cancer burden and highest number of cancer deaths, may help advance global health equity and accelerate the “cure for cancer” through regulatory harmonization initiatives such as Project Orbis.

The Asia Society Policy Institute’s Center for China Analysis

Presenting consistently independent and objective analysis with policy impact, the Asia Society Policy Institute’s Center for China Analysis prioritizes Chinese language source material, emphasizes third-country analyses of China’s international engagement, and actively engages with counterpart institutions around the world as it aims to become one of the world’s leading centers for the study of China and its global role.