Sarah Adam
Associate Director, Regulatory Affairs, IFPMA
Encouraging clinical research in low-income settings is essential to tap into opportunities that can make a difference in patients’ lives.
Creating a sustainable clinical research ecosystem requires open and close collaboration. The pharmaceutical industry is a crucial contributor to this ecosystem in designing, initiating and running global clinical trials according to the highest regulatory and ethical standards. It has been working closely with academics, national regulatory authorities, patient communities and funders to support and strengthen the capacity to conduct clinical research in resource-limited settings.
Key pillars of clinical research
From industry experiences on the ground, and in line with the WHA resolution on Clinical Trials, several key pillars are needed to enable this ecosystem:
Adhering to international regulatory and ethical standards to ensure the safety and wellbeing of participants and patients’ timely access to medicinal products.
Fostering population diversity and inclusiveness in clinical trials in line with the guiding principles for design and conduct of multi-regional clinical trials and taking into consideration ethnic differences in global clinical trials as described in the international standards ICH E17 and ICH E5 respectively.
Investing in the necessary infrastructure for site governance of trials through more sustainable infrastructure, upskilling and innovation for the benefit of pandemic preparedness and boosting R&D capacity in resource-limited settings.
Enhancing clinical research capacity through international public-private partnerships and, more importantly, through local community involvement and ownership for building and retaining a solid local network of experts.
Improving the clinical research environment
in resource-limited settings is
a multi-stakeholder endeavour.
Initiatives enabling clinical trial functions
In Africa, the industry and other partners are collaborating to build clinical trial capacity in ethics and regulatory oversight through initiatives such as the Clinical Trial Community African Network, which collects regulatory and ethics information for African clinical trialists and the WHO African Vaccine Regulatory Forum (AVAREF).
Strategies for clinical research growth
Improving the clinical research environment in resource-limited settings is a multi-stakeholder endeavour. Central to this effort are trust-building, the sharing of best practices and the use of reliance mechanisms for clinical trials. Together, these collaborative strategies pave the way for a more innovative and sustained approach to advancing clinical research in underserved regions.
