The global pharmaceutical landscape is transforming, driven largely by technological advancements, evolving patient needs, and the imperative for inclusive healthcare.
One critical area with immense potential for growth and impact is the inclusion of Sub-Saharan Africa (SSA) in global clinical trials.
By expanding the pharmaceutical value chain to Africa, the continent can address critical healthcare disparities, stimulate economic development, and accelerate the development of innovative treatments.
However, Africa, a continent with immense potential, faces significant challenges in the healthcare sector. One of the most pressing issues is the scarcity of skilled clinical research professionals and robust infrastructure, which called for the inclusion of the global South in clinical trials.
With a vast population and diverse disease burden, experts say the continent offers a valuable resource for drug development. However, it is believed that the key to opening up the market lies in expertise in managing the supply chain and overcoming the varying regulations across the region.
Accordingly, they said further that regional Contract Research Organisations (CROs) and global pharmaceutical companies must address these challenges to unlock the continent’s potential.
“With these benefits in mind, making the continent more attractive for clinical research requires a broad and integrated effort,” Adebukunola Telufusi, Executive Director, Xcene Research and 2024 Impact Africa Summit (IAS) host committee chairlady said, during the 5th edition of Africa’s largest pharmaceutical research, development and clinical trials summit held in Lagos.
The IAS Pharma (IAS) 2024 was organised by Xcene Research, an African Contract Research Organization committed to providing clinical trials access to a more diverse population in Sub-Saharan Africa.
The Impact Africa Summit, a 3-day dialogue and cooperation on deepening clinical trials themed, ‘Expanding the pharmaceutical value chain through inclusion of Sub-Saharan Africa in global clinical trials,’ drive conversations centred on enhancing human resource, adequate infrastructure, operating costs, strengthening links between local and international Pharma organisations, and implementing proper regulations.
According to Telufusi, IAS Pharma 2024 provided a platform for a broad range of experts to highlight critical steps needed in revamping regional harmonization systems and optimizing access to high-quality and effective medical products.
Read also: Nigeria plans to establish 435 clinical trial centres by 2028
“Let us leave this summit inspired and committed to building a more equitable and inclusive future for clinical research on the African continent. Together, we can unlock the immense potential that lies within our diversity,” she urged the participants.
She also emphasised the need for collaboration between the regulatory agencies, CROs and Pharma organisations. Telufusi disclosed that Africa’s untapped potential for clinical trials presents a significant collaborative opportunity for the pharmaceutical industry.
“This collaborative environment has enabled Clinical Research Organizations and healthcare practitioners to navigate these challenging times with clarity and purpose, guiding Africa toward a paradigm shift that harnesses the power of science, research, and innovation,” Telufusi said.
She said that the annual Impact Africa Summit is a catalyst for change that drives transformation in areas of clinical trials, especially within Africa, and the need to include the global South in clinical trials.
According to Telufusi, the annual summit has consistently championed the need for streamlined and harmonized regulatory frameworks across sub-Sahara Africa to facilitate clinical trial conduct.
“The Impact Africa Summit stands as a pivotal event championing clinical trials over recent years and seeks to unlock the true potential of clinical trials in Sub-Saharan Africa. Africa is experiencing a paradigm shift towards harnessing the power of science and research. We firmly believe that by bolstering local partnerships and advocating for active participation and collaboration, we can cultivate an environment that propels medical research forward, ultimately enhancing healthcare outcomes for communities across Africa.”
According to Telufusi, the annual summit emphasised the importance of ethical principles and patient rights in clinical research, ensuring that participants are treated with respect and dignity. She disclosed further that IAS has empowered local researchers and healthcare professionals to conduct high-quality clinical trials by organizing training programs and workshops.
“Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children,” Chika Onwuamah, deputy director and head, Microbiology Department, Nigerian Institute of Medical Research, Lagos, Nigeria, said.
Speaking on ‘Advancements in Biomarker Analysis to Support Clinical Trials in African Populations’, Onwuamah said that African populations have the greatest genomic diversity in the world. “This diversity presents both positive and negative implications for genomic research, personalized and precision medicine.”
According to Onwuamah, genomic diversity precludes summarizing risk across African ethnic groups. She disclosed that underrepresentation in studies, scarcity of reference genomes, inaccuracy of genetic testing and interpretations, and ancestry misclassification, are some of the challenges associated with exclusion in global clinical trials.
Biree Andemariam, American Red Cross Endowed Chair, University of Connecticut, USA, in a paper titled, ‘Transition in Sickle Cell Disease’ said successful transition from pediatric to adult health-care services is correlated with better outcomes due to better adherence, medication management, and self-care.
According to Andemariam, there are practice variations between countries/regions; however, transition must be conceptualized at the geographic level. The professor Medicine said further that globally, children with SCD are now expected to live longer on the back of improved early diagnosis, screening, and preventive treatment. “The availability of knowledgeable adult-oriented health-care providers has not kept pace with the growing population of adults with SCD.”
Yetunde Kuyinu, chairman, LASUTH health research ethics committee (HREC), said that effective communication is not only about conveying information, but ensuring that all stakeholders are informed, respected, and ethically engaged.
In a paper titled, ‘Developing effective communication strategies to address concerns and ensure informed participation of all stakeholders,’ Kuyinu said further that by prioritising ethical principles in communication, organisations can build trust, encourage participation, and mitigate potential conflicts. “Remember, Ethical communication is not a one-time action, but an ongoing commitment that fosters a culture of integrity and inclusivity.”
Oladipo Elijah Kolawole, founder, Helix Biogen Institute, said that leveraging data mining techniques presents a significant opportunity for bioanalytical laboratories in Africa to enhance their performance in clinical trials.
Speaking on ‘Leveraging Data Mining Techniques to Enhance Bioanalytical Laboratories’ Performance in Clinical Trials’, Kolawole said that by improving data management, ensuring regulatory compliance, and fostering collaboration, bioanalytical laboratories can contribute effectively to global health initiatives and improve patient outcomes.
According to him, bioanalytical laboratories play a crucial role in clinical trials by analysing biological samples to assess the safety and efficacy of new drugs. “In Africa, these laboratories face numerous challenges, including data management inefficiencies, regulatory compliance issues, and limited resources.”
He disclosed further that leveraging data mining techniques can significantly enhance laboratory performance, improve data integrity, and streamline processes. According to him, data mining can help identify trends and correlations that inform study designs and outcomes.
Faramola Ogunkoya, project lead, Xcene Research, disclosed that the annual summit is geared towards fostering conversations to bridge the gap in health equity and paving the way for evidence-based medicine and interventions.
“This conference transcends dialogue; it is a catalyst for tangible change in the realm of clinical trials, bringing us one stride closer to a healthier, more inclusive future for all,” she said, disclosing that IAS has consistently attracted a large and diverse audience.
According to Ogunkoya, Xcene Research, the driving force behind the annual IAS, is committed to transforming the clinical research landscape in Sub-Saharan Africa. She disclosed that the company offers a comprehensive range of services, including clinical trial management, data management, and regulatory affairs.
According to her, Xcene Research’s vision extends beyond clinical trials; hence the need to establish the Xcene Research Academy (XRA) to bridge the skills gap in clinical research. She said that the initiative aims to train and empower the next generation of African researchers, ensuring a sustainable pipeline of talent for the industry.
“By leveraging the power of collaboration, innovation, and advocacy, the Impact Africa Summit and Xcene Research are driving the future of healthcare in Africa. By embracing the opportunities presented by global clinical trials, Sub-Saharan Africa can contribute to the development of life-saving treatments, improve patient outcomes, and strengthen its position as a global healthcare hub,” Ogunkoya said.
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