THE onset of Covid-19, and global push for an effective vaccine, brought into focus the importance of the process of approving vaccines.
Certainly, the speed with which the vaccines have been developed has put the clinical trial process into the spotlight, so it’s worth taking a closer look at how these life-saving medications are tested.
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What is a clinical trial?
Basically, a clinical trial is a controlled test performed on a medical substance or intervention, determining whether it’s safe and effective. Under-testing of any drug, as well as not testing the long-term use of drugs, can have disastrous medical implications.
What’s the history of the clinical trial?
Clinical trials have their origins in the 17th century when British navy doctor, James Lind developed a theory that scurvy was caused by a lack of citrus fruit.
Scurvy was one of the biggest killers of the British navy, so a cure was drastically needed.
During the first clinical trial, Lind gave one group cider, one group sulphuric acid, one group, vinegar, one group sea water, one group spicy paste and barley water, and one group oranges and lemons. The results were almost immediate and overwhelming with the group ingesting citrus, and the importance of vitamins in health became quite evident.
How are clinical trials conducted?
Clinical trials are conducted in three phases, with varying patient numbers and dosages to get an accurate indication of the drug’s effectiveness.
•Phase 1: A small group of patients is given the drug to find the highest dose of the new treatment that can be given safely without causing severe side-effects.
•Phase 2: Once Phase 1 has been deemed safe, the second phase begins with the drug administered to a larger group of patients – typically up to a few hundred. This phase determines the optimal dose or doses of a drug to maximise possible benefits, while minimising risks.
•Phase 3: For bigger diseases – like Covid-19 – thousands of participants form part of the trial. Participants will either get the actual drug or a placebo, forming part of the control group.
This provides detailed safety data as a basis for the drug. Clinical trials are all strictly controlled by relevant government agencies such as the Department of Health in South Africa or the Federal Drug Agency [ FDA] in the USA.
How long do clinical trials last?
The importance of safety in drug use means clinical trials for drugs usually last around 10 to 15 years before a drug will be deemed safe to use. This is a major reason the Covid-19 vaccines have garnered so much speculation – that and the misinformed anti-vaxxer dissemination – as the vaccines took less than a year to get to market. However, it’s important to note that this was made possible because:
– Researchers were not starting from scratch when they learned about SARS-CoV-2, the virus that causes Covid-19. There are hundreds of coronaviruses with established research already available.
– Worldwide collaboration and knowledge-sharing overcame hurdles that often exist in vaccine development.
– The provision of funding meant there were no financial constraints that tend to decrease the pace of development.
Importance of a vaccine clinical trial
Vaccine clinical trials are critical to the success of any vaccine, with regulatory authorities approving the vaccine before it is available to the public. This requires the rigorous clinical trial phases with data continued to be collected years after use.
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