Every year on May 20, we celebrate International Clinical Trials Day, an opportunity to promote clinical trials and highlight their important contribution to healthcare.
International Clinical Trials Day commemorates the first-ever randomised clinical trial. On May 20, 1774, James Lind, a ship’s physician in the British Royal Navy, conducted a clinical trial to see how citrus fruits impacted seamen with scurvy. Lind was able to illustrate the link between fruit and preventing scurvy by dividing 12 sailors into numerous groups and assessing the influence of different treatments on each group. Clinical trials have evolved greatly since then and are now an integral component of modern medicine.
What are clinical trials, how do they work, who may take part in them, and are they safe? Naomi Knoblauch, Programme Manager of HMRI’s Clinical Trials Unit, explains.
What exactly is a clinical trial?
Clinical trials are research initiatives in which volunteers evaluate new treatments, procedures, or diagnostics in an attempt to prevent, diagnose, or cure a range of diseases or medical conditions.
They might include assessing medical equipment, changes to health services, medications, immunisations, preventive care programmes, behavioural treatments, and other things.
Why are clinical trials required?
Clinical trials are required for the development of new medicines. We cannot measure the effectiveness of a diagnostic test or the safety of a drug without them.
What are the steps of a clinical study?
The vast majority of clinical trials for new medicines are conducted in phases. If an intervention seems promising in the early stages of a research when examined in a small number of participants, it moves on to future phases that involve more people.
- Phase I clinical trials are done to investigate the safety of a new biomedical intervention in a small population for the first time. This experiment normally has 20 to 80 participants.
- Phase II clinical trials are done to test an intervention in a larger population (typically several hundred people) to determine its efficacy, whether it performs as intended, and to further analyse its safety.
- Phase III trials test an intervention against other conventional or experimental treatments to evaluate whether an intervention is successful in large groups of trial participants (varying from hundreds to thousands). Phase III studies are also used to collect safety data and monitor adverse effects.
- Phase IV studies are conducted after the commercialization of an intervention. These research initiatives are designed to follow the effectiveness of the approved intervention in the general community and collect data on any negative consequences over long time periods.
Clinical study participants might be anybody
Because there are so many various sorts of research being undertaken, almost everyone may participate in one. Trials are open to people of all ages, from newborns to the elderly, and with all types and stages of a disease or condition.
Participants in studies have the option to withdraw at any time, and their participation is fully voluntary.
All clinical trials need participation, but the majority also include inclusion and exclusion criteria to ensure the trial’s relevance, dependability, and contribution to the study’s safety.
Is it safe to do medical experiments?
Clinical trials in Australia are subject to stringent regulations. Several rules and regulations are in place to protect persons who volunteer to participate.
What happens once a clinical trial is completed?
Following the completion of a clinical trial, researchers evaluate all data collected during the study.
After analysing the data, researchers may determine whether to forward the innovative intervention to the next stage of the clinical trial or, if required, request for approval for general use from the relevant regulatory agencies, such as the Therapeutic Goods Administration (TGA).
After demonstrating that a new intervention is safe and effective, it may be added to the standard course of treatment for a disease or condition.