South Africa is the home of clinical trials on the continent, due to several factors; however, challenges persist around these research studies that are designed to answer a specific question about a new drug, device or procedure.
This is according to Fia Samuels, Head: Medical Malpractice at iTOO Special Risks, who explains that two main factors distinguish South Africa from other countries in Africa. The first is that the country’s population is the sixth largest on the continent, at over 60 million, which provides a large and diverse patient population.
“Secondly, the majority of subjects enrolled in clinical trials have not received any previous treatment for their disease, either because it was not available to them, or they cannot afford it. These factors greatly facilitate subject recruitment and help meet diversity requirements,” says Samuels.
Additionally, she says, the lower costs of clinical research and lower risk of litigation make South Africa an attractive destination for foreign companies outsourcing clinical trials.
The challenge
“It is important to remember that South Africa is a diverse nation made up of many diverse ethnic groups, cultures and religions, with 11 official languages. Informed consent and other patient-related materials must therefore be translated into the native language of the patient,” notes Samuels.
Along with the language barrier, the issue of ethical informed consent practices in South Africa is also controversial. Contributing factors include limited education, poverty, inadequate protection of human rights, discrimination based on health status and restricted access to preventive care and treatment options.
Despite these challenges, Samuels points out that South Africa’s relatively well-developed infrastructure and compliance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH-GCP) and South Africa’s robust Guidelines being The Guidelines for Good Practice in Conduct of Clinical Trials in Human Participants in South Africa (3rd Edition) are two factors that have contributed to the country’s growth in clinical research relative to other African countries.
When planning a clinical trial, numerous structural designs of the study are considered. The selection of a design depends on specific research questions, disease and therapy characteristics, control group, and funding. The different types of clinical trials conducted are:
Single-arm prospective study – everyone enrolled in the trial will be treated the same way, namely all participants receive the same experimental treatment or intervention. This design is employed when the objective of the trial is to obtain preliminary evidence of the efficacy of the treatment and to collect additional data.
Randomised control trial (RCT) – compares a group given the therapy (treatment group) with a similar group of people who are not given the therapy (placebo group – placebo meaning fake treatment). The results for both groups are then compared to see if one group does better than the other.
Blind trial – a randomised controlled trial where the treatment and placebo groups don’t know whether they are given the therapy or not. This is to test if patients only improve a little because they believe they are being treated – a phenomenon called the “placebo effect”.
Double-blind trial – when treatment and placebo groups, as well as the doctors or nurses who give out the trial medicine, do not know which patients are getting treatment and the placebo. This is to ensure that there is no unconscious bias on the part of the clinicians when they are conducting the trial or reporting trial results.
“The double-blind randomised controlled trial is the gold standard in clinical trials because it is seen as the most scientific and objective way to determine safety and efficacy,” says Samuels.
Regulation
In terms of regulations, Samuels states all clinical trials in South Africa must be approved by the South African Health Products Regulatory Authority (SAHPRA) and it is mandatory to have insurance coverage for these studies.
“According to the current Good Clinical Practice (GDP) guidelines, all sponsors/applicants and investigators of clinical trials must have adequate comprehensive insurance to cover any liability claim during the conduct of a clinical trial,” she explains.
“GCP guidelines provide broad guidance regarding injuries (including death) for which insurance would be required. Insurance is required for the conduct of interventional clinical trials involving human participants. Hence, evidence of comprehensive, no-fault insurance for serious injury/harm and/or death must be provided by the sponsor and/or applicant of a clinical trial.”
As a result, iTOO Special Risks has introduced comprehensive coverage for clinical trials. iTOO’s Clinical Trials Liability Insurance is a specialised insurance product designed to protect organisations conducting clinical trials from the unique risks and liabilities associated with these activities. It provides coverage for participant injury, illness or death during the trial, ensuring financial and reputational security.
“Our cover is tailored to meet the specific needs of a clinical trial including enhancements of cover and key extensions of the cover. From offering up to R 50 million in capacity to developing competitive deductible structures, iTOO tailors cover of each clinical trial according to its unique needs,” concludes Samuels.
As featured on FANews.
