• Friday, March 29, 2024
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54gene’s new clinical research program to ensure health studies are relevant to Africa

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54gene launched a clinical program on Wednesday that aims to ensure health studies on major diseases like the COVID-19 are relevant to the African continent.

The Clinical Program Services (CPS) division is expected to provide end-to-end clinical development services, intelligence, logistics, and infrastructure to enable the successful conduct of clinical trials in Africa.

The launch is coming at the same time as the appointment of 54gene as the Nigerian country partner for the International Registry of healthcare Workers Exposed to COVID-19 (UNITY Global). Launched by Certara in August 2020, the UNITY Global initiative plans to enable prevention policies to be informed by real-world data collected from 10,000 healthcare workers in low- and middle-income countries.

As a member of the UNITY Global, 54gene will provide clinical trial management oversight and support for all aspects of the study conducted in Nigeria. 54gene’s new research division is led by Kemi Williams, VP, Clinical and Regulatory Affairs, who brings years of driving clinical excellence, delivering regulatory competency, and ensuring operational efficiency to the company.

Jessica Rich, Chief Commercial Officer, 54gene sees the inclusion of Africans in clinical programs as critical to the production of medicines and health products that are more efficacious and safe for people of the continent.

“It is vital that we continue to collaborate with African researchers and institutions to generate data that meets the scientific rigor found in worldwide studies and to increase African inclusion in global studies,” Rich said. “It is essential that more research takes place on the continent and we are ready to be part of that change.”

She also sees the UNITY Global Study as an opportunity for some of the best clinical teams across sub-Saharan Africa to come together and ensure outcomes of any COVID-19 studies are relevant to Africans. For her, the insights from the UNITY Global Study could potentially unlock breakthrough clinical discoveries that can improve health outcomes for millions of people globally.

Countries the study will be targeting include Pakistan; Nigeria; South Africa; Kenya; Uganda; Senegal; Zambia; and Zimbabwe. The objective is to examine the link between the use of preventive treatments and the occurrence of SARS-CoV-2 infection in healthcare workers providing care to patients with COVID-19.

“Healthcare workers have a high incidence of severe COVID-19 as they are repeatedly exposed to individuals infected with SARS-CoV-2,” Roman Casciano, general manager of Certara’s evidence and access group said. “With limited evidence on the effectiveness of the preventative measures and treatments currently being used, collaborating with key partners such as 54gene is inevitable for expanding the current body of research.”

The registry will collect information on a weekly basis from enrollees across a 12-week period. Data collection includes medications being taken by healthcare workers, their level of exposure to COVID-19 patients, their health status, and other factors such as the use of personal protective equipment (PPE), which would likely mitigate their risk of SARS-CoV-2 infection. In addition, the registry will record SARS-CoV-2 antibody test results. The study is funded by a grant from the COVID-10 Therapeutics Accelerator.