Clinical Trials in Inflammatory Bowel Disease – What South African Patients Need to Know
South Africa is a popular country for performing clinical trials as the cost of conducting the trials is cheaper than in other parts of the world and there are many patients who do not have access to treatments which may be available in other countries.
The cost of identifying an effective IBD drug and beginning the process of research and development resulting in a safe and effective drug being available to patients may take as long as 20 years and cost many millions of dollars.
Once a drug has shown promise as an effective IBD treatment and is safe enough to be used in patients then clinical trials are started whereby hundreds of patients from around the world get to use the drug in a very controlled program with close monitoring to determine how effective the drug is, and if there are any side-effects associated with its use.
All the current biological drugs available in South Africa infliximab (Revellex), adalimumab (Humira), ustekinumab (Stelara) and the soon to launched vedolizumab (Entyvio) were initially used in clinical trials and thousands of patients now benefit from the knowledge gained from these trials.
South African patients are often denied treatment with the most effective drugs, particularly biological drugs, because these are either not available in the public sector or medical aids will not pay for these expensive medications. In fact the vast majority of IBD patients in South Africa have no access to biological treatment.
Clinical trials provide an opportunity for some South African IBD patients to gain access to the latest biological drugs free of charge. In addition many components of IBD care such as colonoscopy, blood tests and consultations are also included as part of the trial program. In return the trial organisers will insist that you monitor your IBD very closely with a diary, attend visits regularly and comply with other trial instructions.