The Future of Clinical Trials in South Africa
16 October 2024 Kirsten Kirkwood, Senior Professional Indemnity and Clinical Trial Underwriter at SHA Risk Specialists
South Africa is a significant hub for clinical trials in Africa, particularly in the sphere of infectious diseases. A large portion of clinical trials in South Africa is dedicated to researching and developing treatments for HIV, tuberculosis, and malaria given local statistics of these infectious diseases.
While South Africa's clinical trial market may not be as large as other regions in the world, it has seen noticeable growth in recent years. Numerous pharmaceutical companies, clinical research organisations (CROs), and academic institutions have established operations in the country. The main governing body for Clinical Trials outside of the legislative frameworks that exist is the South African Health Products Regulatory Authority (SAHPRA), responsible for overseeing the safety, quality, and efficacy of all medicines, medical devices, and related products in South Africa.
The Clinical Trial Process The traditional clinical trial process is a lengthy and complex endeavor, typically involving the following stages:
1. Drug Discovery: Identifying a potential drug candidate through research and development.2. Preclinical Testing: Testing the drug on animals to assess safety and efficacy. 3. Clinical Trials: Testing the drug on humans in multiple phases:
• Phase I: The focus is to assess safety, tolerability, and pharmacokinetics (how the body absorbs, distributes, metabolises, and excretes the substance).• Phase II: The focus is on efficacy, safety, and dosage determination.• Phase III: The focus is to confirm efficacy and safety on a larger scale of research subjects.• Phase IV: The focus is to collect additional data on long-term safety and efficacy.
4. Regulatory Approval: Submitting data to regulatory authorities for drug approval.5. Post-Market Surveillance: Monitoring drug performance and safety after release to market.
Looking Ahead Given the rapid advancements in technology, it is imperative to explore tools that could fundamentally transform the way clinical trials are conducted, potentially accelerating traditional timelines.
Artificial Intelligence (AI) is rapidly transforming various industries, and healthcare is no exception. By leveraging AI's capabilities, researchers can potentially streamline the trial process, accelerate drug development, and enhance patient outcomes.
AI can assist with identifying suitable patients more efficiently through advanced data analysis, generating valuable insights from complex datasets and identifying patterns and trends more efficiently. Using AI is also likely to result in a reduction in trial costs and timelines through efficient resource allocation. AI can also impact regulatory compliance by automating the data management and reporting processes.
One of the biggest challenges that currently exists with AI is algorithm bias, which occurs when an AI system makes systematically unfair decisions due to biases present in the data it was trained on. This would impact the integrity of the data it provides.
Clinical Trial Insurance SAHPRA requires each clinical trial to carry its own liability insurance to protect the participants of the trial against bodily injury, death, or property damage caused by the clinical trial.
There are 2 forms of liability cover for clinical trials namely No-Fault Liability and Legal Liability.
1. No-Fault Liability occurs where participants are provided with compensation for injuries and/or damages sustained during the trial without the onus of proving that there was negligence on the part of the trial sponsor/facilitator or investigators. 2. Legal Liability occurs when a person or entity is legally responsible for causing harm or damage as a result of their actions/services. This type of policy requires a third-party to initiate legal action against the insured to prove that their negligence caused the harm and/or damage.
SHA a division of Santam Limited is a long-standing clinical trial insurance provider offering a product on a no-fault basis. No-fault clinical trial insurance is mandatory in South Africa, as this strengthens the ethical and safety requirements within the nation's clinical research environment and offers crucial protection for trial participants.
A list of all clinical trials currently being undertaken can be found on the South African National Clinical Trials Register (SANCTR) website which is open to the public.
