UKZN’s First Clinical Trials Unit Launched

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The College of Health Sciences (CHS) is proud to announce the establishment of UKZN’s first Clinical Trials Unit (CTU), based at the Nelson R. Mandela School of Medicine.

Aspiring to research excellence, the CTU will support researchers in conducting impactful clinical trials on new therapeutic agents targeting infectious and non-communicable diseases relevant to the South African population.

Led by research scientist Professor Daya Moodley, this landmark unit is a game-changer for health research in KwaZulu-Natal. It features two standout innovations that include an A-graded on-site pharmacy and a dedicated Pharmacokinetic Clinical Ward. These state-of-the-art facilities enable scientifically rigorous, ethically sound clinical trials, empowering researchers to test new therapeutic agents that tackle both infectious and non-communicable diseases affecting South Africans.

At the launch of the CTU, Professor Busisiwe Ncama - Deputy Vice-Chancellor and Head of the CHS - said: “The CTU is more than a facility for us. It’s a hub where curiosity, cutting-edge science and collaboration will converge to push the boundaries of medical research in order to address the health challenges of our region and establish UKZN as a global leader in clinical trials and healthcare innovation. Congratulations to the incredible team who made this possible: Professors Daya Moodley, Ncoza Dlova, Anil Chuturgoon, Nhlanhla Msomi, Fanie Botha, and the Abdool-Karims for their expert guidance - with special thanks to the Technology Innovation Agency (TIA) for the funding support.”

Chuturgoon, UKZN’s Acting Deputy Vice-Chancellor of Research, emphasised that the CTU will play a key role in advancing the University’s research agenda and improving health outcomes locally and globally. He described the CTU as a specialised hub for conducting high-quality clinical trials, fostering innovation in treatment and diagnostics. The unit will enhance research capacity, ensuring studies meet top scientific and ethical standards, while offering expertise in areas like epidemiology, biostatistics, and regulatory compliance. Importantly, it will also serve as a training ground for future medical scientists and clinicians. 

Moodley explained the critical role clinical trials play in the drug development process. She outlined the full pathway - from discovering a disease-related molecule to identifying compounds, conducting preclinical studies, and progressing through the clinical trial phases:

•    Phase 1: Tests safety and identifies the best dosage

•    Phase 2: Evaluates the drug on a small group with the condition

•    Phase 3: Compares the treatment to current options for effectiveness.

Successful Phase 3 trials lead to regulatory submissions (eg. to the Food and Drug Administration or European Medicines Agency) for approval. She highlighted that this process can take up to 20 years, citing the development of antiretrovirals (ARVs) as an example.

Moodley stressed the need for better treatments for both infectious and non-communicable diseases (NCDs). Referring to a 2018 Statistics South Africa (Stats SA) report, she noted that in KwaZulu-Natal, the leading causes of death included tuberculosis (especially MDR-TB and XDR-TB), heart disease, diabetes, stroke, hypertension, cancers, and respiratory illnesses.

She said: “The UKZN CTU was established not to compete with existing research institutions but to complement them by supporting physicians in finding improved treatments, particularly for NCDs. We are currently hosting five to six clinical trials covering respiratory, dermatological, dental, and obstetric conditions - including one repurposing a diabetes drug to prevent preeclampsia.”

Dr Phumlani Tetyana, Acting Head of Health at TIA, expressed pride in supporting the establishment of the CTU. He emphasised its vital role in developing and evaluating new therapies for NCDs, particularly those impacting marginalised communities. The CTU, he said, is key to building a strong health innovation ecosystem and translating research into real-world solutions. He commended Professor Moodley and her team and reaffirmed TIA’s commitment to ongoing collaboration in advancing healthcare innovation.

Professor Ncoza Dlova, former Dean of the School of Clinical Medicine and a founding member of the CTU, recalled how a visit to the Centre for the AIDS Programme of Research in South Africa (CAPRISA) Clinical Trials Unit sparked the idea of establishing a similar unit at UKZN. Calling it a proud and emotional milestone for herself, Professor Daya Moodley, and the entire College, she extended heartfelt thanks to the CHS leadership, sponsors, and everyone who supported the vision. She said, “This visionary unit is the result of five years of planning, dedication, and collaboration - a proud moment for CHS and UKZN as we push the frontiers of health research excellence.”

Professor Refiloe Masekela, Dean of the School of Medicine, warmly congratulated everyone involved in establishing the CTU, acknowledging the many meetings and challenges that at times made the process feel like “climbing a steep mountain”.

She said: “This unit is essential for developing much-needed solutions and innovations to address Africa’s current low capacity in NCD research.” She assured the team of the School’s full support and expressed hope that, over the next five years, they will make further strides toward realising the vision of establishing a Clinical Research Organisation to advance health research even further.

Professor Neil Koorbanally, UKZN’s Dean of Research, congratulated the team, describing this as a significant step forward. “I am confident that visitors to UKZN’s Medical School, upon seeing these clinical trials, will return and say, 'Have you seen this at UKZN?' This development will truly put us on the map. Congratulations once again. I am certain this will elevate both the Medical School and UKZN’s reputation.”

View the CTU here. 

Words: MaryAnn Francis

Photographs: Supplied