How Can Lower-Income Countries Maintain Representation in Clinical Trials? – CancerNetwork

Report on Global Equity in Cellular Therapy Clinical Trials

Executive Summary

A significant global disparity exists in the location and representation of cancer-related clinical trials, with a majority concentrated in the United States. This imbalance poses a critical challenge to achieving several Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being), SDG 10 (Reduced Inequalities), and SDG 17 (Partnerships for the Goals). Addressing this requires a concerted effort involving regulatory pressure, infrastructure development in lower- and middle-income countries (LMICs), and the cultivation of trust between pharmaceutical companies and global health institutions. This report, based on insights from Dr. Syed Osman Ali Ahmed at the 2025 Immune Cell Effector Therapy (ICE-T) Congress, outlines the key issues and proposes a framework for creating a more equitable global clinical trial landscape.

Challenges to Sustainable Development in Global Health Research

Impediments to SDG 3: Good Health and Well-being

The current concentration of clinical trials presents a direct obstacle to ensuring healthy lives and promoting well-being for all at all ages. Key challenges include:

• Geographic Concentration: The overwhelming majority of advanced cancer trials occur in a few high-income nations, limiting access for patients in other regions.
• Lack of Genetic Diversity: Failure to include diverse populations neglects region-specific genetic factors, potentially limiting the efficacy and safety of new therapies for a global population.
• Inequitable Access to Innovation: Patients in LMICs are systematically excluded from accessing cutting-edge cellular therapeutics available through registrational trials.

A Framework for Achieving Equity in Clinical Trials

Regulatory Mandates to Advance SDG 10: Reduced Inequalities

Regulatory bodies have a crucial role in reducing health inequalities between and within countries. Strategic actions can compel industry to broaden the scope of their research:

1. Enforce Local Representation: Countries can mandate that a specific number of local patients be enrolled in registrational trials before a product can be marketed in that country, as is done in Saudi Arabia.
2. Apply International Pressure: Regulators in both Western nations and LMICs must exert pressure on pharmaceutical companies to ensure trial enrollment is globally representative.
3. Promote Inclusive Research: Mandates for greater ethnic and geographic representation in trials for advanced and expensive therapies are essential to ensure benefits are shared more equitably.

Infrastructure Development for SDG 9: Industry, Innovation, and Infrastructure

For LMICs to participate fully, they must build resilient infrastructure and foster an environment of innovation. This involves a targeted investment in creating a trustworthy clinical trial ecosystem.

• Organize the Clinical Trial Ecosystem: LMICs with large populations must invest in organizing their research frameworks to make them efficient and attractive to industry partners.
• Streamline Institutional Processes: By reducing administrative delays and shortening trial startup times, institutions can build a reputation for efficiency and reliability.
• Build Institutional Capacity: A small investment to streamline processes can lead to significant long-term gains, positioning an institution as a gateway for regional clinical research.

Fostering Collaboration for SDG 17: Partnerships for the Goals

Creating a truly global clinical trial network depends on building strong partnerships between the public and private sectors. Trust is the foundational element of this collaboration.

• Build Confidence and Trust: The primary barrier to industry expansion is often a lack of confidence in local ecosystems. Successful trials at a single trusted institution can build confidence in the entire country and region.
• Encourage Industry Risk-Taking: Industry partners must be encouraged to look beyond immediate financial interests and recognize the greater humanitarian benefit of making innovative trials accessible to more patients worldwide.
• Leverage Past Successes: The successful implementation of large-scale trials for conditions like hepatitis, sickle cell disease, and various infections in LMICs demonstrates that complex research can be conducted effectively when a trusted ecosystem is in place.

Analysis of Sustainable Development Goals in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being: The article’s central theme is improving global health outcomes for cancer patients by making advanced cellular therapies and clinical trials more accessible worldwide. This directly relates to ensuring healthy lives and promoting well-being for all.
• SDG 10: Reduced Inequalities: The article explicitly addresses the disparity in clinical trial representation between high-income countries like the US and lower- and middle-income countries. It calls for “greater ethnic representation” and a “more representative enrollment of patients” across the world, aiming to reduce health inequalities.
• SDG 17: Partnerships for the Goals: The article emphasizes the need for collaboration to solve the issue. It describes a multi-stakeholder approach involving pharmaceutical companies (industry), regulators in both Western and local countries, and healthcare institutions in lower- and middle-income nations. Building “confidence and trust” between these partners is presented as essential.
• SDG 9: Industry, Innovation, and Infrastructure: The discussion on the need for lower- and middle-income countries to “organize the clinical trial ecosystem” and develop institutions points to building resilient healthcare infrastructure and fostering innovation within these countries to support advanced scientific research.

2. What specific targets under those SDGs can be identified based on the article’s content?

1. Under SDG 3 (Good Health and Well-being):
   • Target 3.4: Reduce premature mortality from non-communicable diseases. The article focuses on cancer, a primary non-communicable disease. Expanding access to innovative trials for “advanced therapies” is a direct strategy to improve treatment and reduce mortality.
   • Target 3.b: Support research and development of medicines for non-communicable diseases that affect developing countries. The article is a call to action to include patients from lower- and middle-income countries in the “registrational trials” for new cancer therapies, directly supporting R&D in contexts relevant to these nations.
2. Under SDG 10 (Reduced Inequalities):
   • Target 10.2: Empower and promote the social inclusion of all, irrespective of origin or economic status. The call for “greater ethnic representation” and the inclusion of patients from the Middle East, Asia, and other regions in trials is a direct effort to promote inclusion in health research and access to care.
   • Target 10.3: Ensure equal opportunity and reduce inequalities of outcome. The article discusses using “regulatory pressure” and national stipulations—such as requiring local patient enrollment before a therapy can be marketed—as policy actions to ensure more equal opportunities for global populations to access cutting-edge treatments.
3. Under SDG 17 (Partnerships for the Goals):
   • Target 17.16: Enhance the global partnership for sustainable development. The article’s narrative is built around the need for partnerships between industry, regulators, and local institutions to “build confidence and trust” and share expertise to make trials accessible.
   • Target 17.17: Encourage and promote effective public-private partnerships. The collaboration described between private pharmaceutical companies (“industry”) and public bodies (regulators, national hospitals like King Faisal Specialist Hospital) is a clear example of the public-private partnerships needed to achieve these goals.
4. Under SDG 9 (Industry, Innovation, and Infrastructure):
   • Target 9.5: Enhance scientific research and upgrade technological capabilities. The article advocates for investment by lower- and middle-income countries to “organize the clinical trial ecosystem” and “streamline the processes,” which constitutes an upgrade of their scientific research infrastructure and capabilities.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

Yes, the article mentions or implies several measurable indicators:

• Number of local patients enrolled in registrational trials: The article explicitly states that many countries “stipulate that if you’re going to market a therapy [in these countries], you should have enrolled patients on those registrational trials.” This is a direct, quantifiable indicator of local representation.
• Geographic and ethnic diversity of trial participants: The call to “go across the world and get a more representative enrollment of patients” and the mention of an “increasing mandate to have greater ethnic representation” imply that the proportion of participants from various regions and ethnic backgrounds is a key metric.
• Number of industry-sponsored trials in lower- and middle-income countries: Progress can be measured by tracking how many trials “industry or partners” open in institutions within these countries once “confidence gets built.”
• Efficiency of trial initiation processes: The article mentions that a barrier was that “the timelines were too long.” A key indicator of an improved “trial ecosystem” is a reduction in the “time to enroll in an opening trial,” which was achieved by streamlining processes.

4. Summary Table of SDGs, Targets, and Indicators

Source: cancernetwork.com