Home 2 Forums Covid -19 Potential and challenges of doing randomised clinical trials

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    Sunil Kumar
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    Many low-income and middle-income countries will regrettably have only a small proportion of their population vaccinated against SARS-CoV-2 during 2021–22.19
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    Placing trials in resource-poor settings could be a reasonable or likely to be the only feasible way forward for the clinical development of many COVID-19 vaccine candidates, which would help to fulfill the legitimate aspiration to having trials run in their territories in low-income and middle-income countries.22
    Inequity will be an ethical challenge as many low-income and middle-income countries are left behind in the access to vaccines, which will clearly contradict what is stated in the Sustainable Development Goals.23
    The wider issue of affordability and availability of vaccines in many low-income and middle-income countries is an important ethical issue, but outside the scope of this Personal View.
    When doing trials of COVID-19 vaccine candidates in countries with limited affordability and availability of COVID-19 vaccines, sponsors from high-income countries should seek to allay any concern of ethics dumping24
    or exploitation of the host trial participants and communities. To ensure the equitable, non-exploitative, and respectful conduct of trials in countries with limited affordability and availability of COVID-19 vaccines, sponsors must fulfil the following three principles:25
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    (1) the research should be responsive to local health needs (ie, should be done in communities with a high burden of COVID-19; (2) both research participants and host communities should benefit from the research; and (3) the COVID-19 vaccine candidates to be tested in countries with limited affordability and availability of COVID-19 vaccines should be those that could eventually be deployed—at an affordable price—in the countries where the trials were done. For instance, vaccine candidates needing ultra-low temperature conditions (−70°C) should not be tested in countries with limited affordability and availability of COVID-19 vaccines without the infrastructure that ensures safe and regular long-term storage and distribution of vaccines under real-life conditions.

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    https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00263-2/fulltext

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