Global Harmonization of Cancer Trials

Successful harmonization means enhanced life-changing therapies for cancer patients. Our collaborative efforts will result in “a drug approved anywhere being available everywhere.”

The Challenge

Experts in oncology agree that harmonizing approval processes and clinical trials globally will benefit patients and save lives. The current state of cancer care highlights several major challenges:

  • Many individuals lack access to clinical trials and the benefits that accrue from them
  • Disharmony slows the development and regulatory approval of cancer treatments
  • Global infrastructure and collaboration must improve

Although it is generally accepted that harmonization is important, a targeted and focused effort to achieve this goal is lacking. To address these challenges, we seek to unite stakeholders and advance the advantages of globally harmonized clinical trials.

Strategic Imperatives

Standards and Best Practices

Define and communicate standards and best practices to streamline cancer trials and maximize equitable participation

Advocacy and Awareness

Create a global forum to drive international collaboration, advocacy and awareness

Education and Support

Provide education, support and advanced solutions for the oncologist community

Call to Action

The pandemic taught us about the power of collaboration and that we can successfully fight huge medical challenges at speed.

Now it’s urgent that we do the same for cancer. We need to use these lessons learned to accelerate equitable access to cancer clinical trials.
quote harmony

Mission & Vision

The existing disparities in clinical trial accessibility deny many cancer patients potential life-sparing benefits. This disharmony impedes the development and regulatory approval of cancer treatments on a global scale. Although the International Council for Harmonisation (ICH) has provided guidelines and encouraged criteria, their implementation remains unfulfilled. In response, HARMONY is fostering a global collaborative.

With ten million cancer patient deaths annually, it is clearly time to accelerate the goal of building this global network of medical allies to expedite and coordinate global cancer clinical trials and identify areas of congruence among principal regulatory agencies around the world. Harmonizing will enhance life-changing therapies for cancer patients with success defined as “A drug approved anywhere will be available everywhere.

Meet Our Board Members

HARMONY, a keystone initiative of the Society for Translational Oncology (STO), is guided by a Mission Advisory Board to enhance and support the development of strategies for improved cancer treatment and prevention.

Symposium: Dakar, Senegal, November 3, 2023

Cancer, A Looming Public Health Crisis in Africa:  

A Call to Accelerate Equitable Access to Medicines

A panel of experts discussed key strategies for accelerating the availability of cancer medicines in Africa through a collective and collaborative approach. They addressed the importance of well-designed and meticulously executed clinical trials, along with harmonization and data sharing. Beyond medicine development, the Symposium emphasized the significance of education, training, and the integration of new learnings into the practice of healthcare providers.

Faculty

  • Prof. Rose Anorlu, MBChB, FMCOG, FRCOG, FWACS, MPH, Immediate Past President, AORTIC
  • Satish Gopal, MD, MPH, Director, Center for Global Health, US National Cancer Institute
  • Sujha Subramanian, PhD, President, Implenomics
  • Martin J. Murphy, DMedSc, PhD, FASCO, Chairman, Society for Translational Oncology/HARMONY

Key Takeaways

  • Nine out of the 10 countries with the highest poverty rates globally are in sub-Saharan Africa.
  • Cancer Clinical trials in low- and middle-income countries (LMICs) including Africa are unjustifiably few and those conducted in high-income countries (HICs) may not generalize well to Africa.
  • Cancer clinical trials in Africa must be appropriately contextualized if they are to save lives and inform cancer world wide.
  • Harmonizing clinical trials in Africa offers the opportunity to assess strategies that can accelerate access to cancer care services alongside clinical studies.
  • The increase in the incidence of cancer and mortality from it in the world by 2040 will be highest in sub-Saharan Africa.
  • Cancer treatment in Africa is lacking due to very few clinical trials in the region.
  • An integrated approach to develop both the clinical evidence and implementation strategies related to acceptability, feasibility and affordability is essential to increase reach of cancer care and advance equity.
  • There is a need for affordable and effective cancer treatments that includes the enrollment of Africans living in Africa in appropriate clinical trials.
  • Engaging policy makers, implementers and providers early in the planning process will ensure timely implementation of effective cancer interventions.
STO gratefully acknowledges the vital partnership and support of:

STO welcomes additional financial support; please contact us for more information.

Organizations of Interest