Clinical trials are pulling in up to R2-billion a year into South Africa, yet researchers fear the industry may be compromised by the slowness of regulatory authorities to approve, or reject, potential trials.
The issue was thrown into relief by an incident in the United Kingdom, when six clinical trial subjects ended up in intensive care after being injected with a part mouse, part human monoclonal antibody.
All medicines tested on humans in South Africa must be registered by the Medicines Control Council (MCC), which also has a duty to check that its rules are being followed. But the MCC only has a handful of monitors, leaving the monitoring role to industry regulatory bodies. And researchers are concerned that its lack of human resources is slowing down the clinical trials registration process, encouraging companies to look elsewhere.
South African regulators have to balance competing in a competitive international market with ensuring that trial participants are not exploited.
Apart from the financial benefits, clinical trials increase investment in laboratories and technology and develop the skills of health workers and scientists. They also give sick people the option of treatment with drugs that are unobtainable because they are still experimental, have not been registered for use in South Africa, or are too expensive.
However, it is not unknown for multinational drugs companies to test unproven drugs on vulnerable subjects in the developing world.
Before a clinical trial is conducted in South Africa it must pass through an ethics committee, which assesses the design of the study and the trade-off between risks and benefits to trial participants.
National guidelines on human drug trials are also being drawn up in conjunction with the Department of Health, with plans for a national Registrar of Research and a website that will publicly track all clinical trials. This website will also provide patients with information and alert them to trials for which they may be suitable.
Researchers also have to apply for registration with the MCC.
Among the beneficiaries of trials in South Africa is the Wits Health Consortium, which is part of Wits University. Consortium chief operating officer Maureen Joffe said her organisation earned about R230-million a year from clinical trials, which helped support non-commercial medical research.
Joffe estimated that there were more than 250 applications for phase one to four commercial studies each year in South Africa, with major areas of research being cardiology, oncology, psychiatry and neurological disorders and HIV/Aids. Most trials are phase three or four efficacy and safety studies, which can involve hundreds of subjects, often as part of a multinational programme. The recommended rate for patients is R150 a visit.
South Africa sees few phase one trials, when drugs are tested on humans for the first time.
Part of the attraction of South Africa for clinical trials is the reputation of its scientists and a respected regulatory framework that complies with international gold standards.
Perhaps the biggest concern is ensuring that protocols are adhered to. In varying degrees clinical trials are self-regulating, particularly when they involve many researchers who should be subject to ongoing monitoring.
The situation can be more problematic when a researcher is conducting a trial alone, especially if he or she is working on innovative research where there is a greater risk of unethical behaviour. This is where monitoring by ethics committees has to come in — or evaluation by the monitoring inspectors of the MCC.
Individual researchers doing private sector clinical trials face a potential perverse incentive, as they are often paid per patient enrolled and seen. This gives a direct financial incentive to enrol patients as fast as possible and to keep them there — even if this means cutting corners, such as not fully educating patients.
To counter this, pharmaceutical companies have so much riding on later stage clinical trials that they do their own monitoring. Often they send in unannounced audit hit squads to interview patients.