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Multinational clinical trials in oncology and post-trial benefits for host countries: where do we stand?
Max S Mano1, Daniela D Rosa, Lissandra Dal Lago
1Institut Jules Bordet, Unité d'Oncologie Médicale, Rue Héger-Bordet 01, 1000 Brussels, Belgium. max.mano@gmail.com
Abstract:
International collaboration has undoubtedly played a key role in the extraordinary progress we have witnessed in some areas of oncology in recent years. It has allowed us, for instance, to design trials large enough to depict very small benefits, as well as high-quality trials in less incident types of cancer. For different reasons, developing countries have also shown growing interest in this international effort and have been participating in many international trials. However, the ever-growing costs of novel anti-cancer treatments and technologies have created unprecedented difficulties for health economies in developing countries. Although the issue of individual benefit for patients must also be taken into account, the actual benefit for their society may be minimal. This paper discusses the ethics of including patients from non-developed countries in clinical trials evaluating the role of treatments that are unlikely to be made available to them after the trial because of prohibitive costs. Upfront arrangements ensuring post-trial access to interventions that have been proven successful might be the best alternative to exclusion from the research.
Insights
International clinical trials offer benefits but pose ethical challenges for developing nations. Ensuring post-trial access to successful cancer treatments is crucial for equitable research participation.
Area of Science:
- Oncology
- Global Health Ethics
- Clinical Trial Research
Background:
- International collaboration has accelerated oncology research, enabling large-scale and high-quality clinical trials.
- Developing countries increasingly participate in global research efforts.
- Rising costs of novel cancer treatments create significant economic barriers for developing nations.
Purpose of the Study:
- To discuss the ethical considerations of including patients from developing countries in clinical trials for expensive cancer treatments.
- To explore the ethical implications when treatments proven effective in trials are unlikely to be accessible post-trial due to cost.
Main Methods:
- Ethical analysis of patient inclusion in international oncology clinical trials.
- Discussion of economic disparities and post-trial access to cancer therapies.
Main Results:
- While international collaboration yields scientific advancements, it presents ethical dilemmas regarding patient access to costly treatments in developing countries.
- The societal benefit for developing nations may be limited if proven treatments remain unaffordable.
Conclusions:
- Excluding patients from developing countries due to cost concerns is ethically problematic.
- Establishing upfront agreements for post-trial access to successful interventions is a potential solution to ensure equitable participation and benefit.
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