International Collaboration and International Regulatory Harmonization Can Combat Cancer: The Common Enemy of Humanity
Clinical trials are subject to cumbersome regulatory oversight, very expensive, and can take years to develop and execute. The journey from discovery to prescription takes approximately 10 to 15 years. If we stick to this status quo, we will not see the cure for cancer in our lifetime or even our grandchildren’s lifetime. There is a better way to serve patients and their families who are suffering today and accelerate the path to new life-saving therapies.
The lack of harmonization among international regulators presents the most significant barrier in worldwide efforts to develop novel strategies for cancer treatment and prevention. The United States has made significant progress in setting up an international regulatory infrastructure with Project Orbis, an initiative of the Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). The goal is to take that framework and further internationalize it, to have clinical trials in all participating nations follow the same criteria, which would allow a company seeking approval of an anti-cancer drug to submit one set of applications to regulators in those countries at the same time, permit those regulators to review such applications concurrently, and facilitate a dialogue among them on how to improve global clinical trials. This could save years in duplicative regulatory reviews and accelerate patients’ access to innovative cancer treatments and prevention.
International standardization and concurrent approvals could help 10% of all cancer patients reduce their risk of death by 10% to 20% annually, representing 1 to 2 million lives a year.
China and the United States account for 40% of the world’s 10 million annual cancer deaths. However, no country is spared and the global cancer burden is expected to increase.
To fight this common enemy, greater international collaboration on cancer clinical trials is required, particularly between the United States and China. Working together, we could accelerate the development and delivery of more effective treatments and prevention to patients, saving millions of lives around the world.
The United States Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) initiation of Project Orbis in May 2019 was a welcome step, but more can be done.
To find out more, watch the video below
“To accelerate the eradication of cancer globally, we need multi-stakeholder, multi-regional collaboration — that brings together academia, industry, government, patient advocacy, and policy think tanks from different regions for collective actions — to promote both patient-centric clinical trials and international regulatory harmonization. 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 U.S. and China, bringing some stabilizing and positive force for the bilateral relationship and beyond.”
The Honorable Dr. Kevin RuddPresident and CEO, Asia Society; President, Asia Society Policy Institute; Founder, Center for China Analysis
To start building an international system, we recommend that countries around the world take the following steps:
- Strengthen regulatory bodies
- Preliminarily define requirements for ethnicity-specific trials
- Standardize manufacturing inspections
- Reform insurance coverage for life-prolonging treatments.