Sponsors: Plan Studies Well in South Africa or Communities will Intervene and Plan on your Behalf

Sponsors Plan Studies Well in South Africa or Communities will Intervene and Plan on your Behalf

Does a clinical trials sponsor or their CRO need to provide study staff and subjects Personal Protective Equipment (PPE)? Do “civil society” groups have rights to govern a clinical trial? Vexing questions are surfacing in what is becoming a charged COVID-19 vaccine clinical trial in South Africa. On one side is the study sponsor, a South African contract research organization (CRO) called TASK Applied Science, and on the other side is a growing list of increasingly perturbed community-based groups, labor unions and local and international “advocacy” groups. With tensions mounting, the civic society advocacy groups are calling for a temporary suspension of this study to review not only participant safety—including investigators, coordinator and others involved—as well as a review of the perceived lack of transparency and community engagement as is required in South Africa. This study gets more costly by the day.

The Clinical Trial

As the SARS-CoV-2-driven COVID-19 pandemic spreads and takes more lives (over 435,000 as of this writing), health authorities around the world push for a vaccine that can stop the pathogen. Strategies to prevent illness and death of health workers a...

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