Thursday, 11 August, 2022
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The critical role of clinical research

Worldwide, research helps find the root cause of the health challenges or diseases in our society, identifies ways to improve behaviours of the affected community, and finds solutions to our health issues.

Clinical research – aimed at evaluating a medical, surgical or behavioural intervention – helps resolve complex challenges in our societies. It is the primary way for researchers to establish whether or not a new treatment is safe and effective.

Writing for Health-E News, Ncengani Mthethwa says research has a much more significant impact when researchers and communities partner to ensure it benefits society with interventions most needed to improve the lives of South Africans.

We need research that treats community participants respectfully, where confidentiality is maintained, informed consent is thoroughly conducted, and their participation is acknowledged during the clinical trial.

COVID-19 illustrated the critical nature of research as information gathered enabled evidence-based interventions. More than 35m COVID-19 vaccines have been administered in the country, and more than 11bn vaccines administered worldwide.

The Sisonke Vaccine study provided evidence that vaccinated people are less likely to die or get severely ill.
Researchers like Professor Glenda Gray and Professor Ameena Goga, who led the Sisonke research, reported that they saw positive outcomes regarding vaccine side effects, hospitalisation, and death rates in 2021.

Another example of the impact of research is the use of the Dapivirine vaginal ring, which the South African Health Products Regulatory Authority (SAHPRA) approved in March 2022, and which helps prevent HIV infection among women 18 years and older.

The ring is a non-nucleoside reverse transcriptase inhibitor that blocks HIV’s ability to multiply inside the body. The results of the research led to its final approval.

How research confirmed ‘ breast is best’

Research at Mtubatuba focused on pregnant women who were encouraged to exclusively breastfeed their babies immediately after delivery until their babies turned six-months-old.

Women were recruited into the study during pregnancy and counselled on infant feeding options regardless of their HIV status. Breastfeeding counsellors would stay in close contact to ensure the women couldn’t mix feed. Nurses and study clinicians also worked closely with the women during pregnancy and right up until the babies turned two-years-old.

HIV-positive women were given Nevirapine, which they swallowed immediately they went into labour. This prevented mother-to-child HIV transmission. This study found that HIV infection was minimal if babies were breastfed exclusively, and the administering of the Nevirapine lowered the risk of mother-to-child transmission. Today, the World Health Organisation (WHO) recommends that breastmilk is the best.

Research does not take place in a vacuum

Some may argue that researchers use people to profit from the outcome. Some even argue research can be harmful to the lives of study participants. Research does not, however, take place in a vacuum. The studies follow clear protocols with ethical guidelines.

Health authorities play a crucial role in ensuring that research is appropriately conducted and has long-term benefits to the communities it serves.

Yes, research requires funding, but the aim is not simply to raise funds. Funding is needed to pay staff, secure resources such as vehicles, property, and administration, and ultimately produce the knowledge that can assist with better health outcomes.

Communities where the research takes place play a critical role in ensuring this can happen by participating in clinical trials. Increased participation in research gives study groups and scientists accurate data that can be used to answer research questions and help plan the best interventions and treatments for communities.

Ncengani Mthethwa is the Community Manager for the South African Medical Research Council (SAMRC).


HHealth-E News article – Critical role of clinical research (Open access)


See more from MedicalBrief archives:


Encouraging safety results from Sisonke trial of J&J vaccine in SA


SAHPRA approves ‘game-changer’ vaginal ring but DoH still undecided


Breastfeeding duration linked to cognition – Oxford study




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