Clinical trials 101 information

Clinical trials are carefully planned by a team of researchers which usually include healthcare professionals and doctors. These plans, and the trial itself, also have to be approved before it can begin.

The medical regulators and approval process for a clinical trial is different in each country. They make a decision by weighing the risks and benefits of all factors of any proposed trial. Approval of the trial doesn't mean the treatment is safe, only that the trial is safe and reasonable to proceed.

After approval of the trial, the treatment or intervention is tested on a small number of people in the early phases. If that phase is successful then it undergoes further phases of testing which includes a larger and more diverse group of people. At each point, the volunteers of the trial are carefully monitored throughout the process for any side effects and the effectiveness of the treatment or intervention.

After completion of the trial, the data will be put together and presented to the medical regulator in that country to seek approval for the treatment to be able to be used. In the US, this is the Food and Drug Administration (FDA) who will give approval.

All approved vaccines, including the COVID-19 vaccine, have gone through all these stages of the clinical trials, meaning that it has been thoroughly tested and is safe for use.

There are paid and volunteer roles available for people wanting to be part of clinical trials. We would recommend discussing this with your doctor prior to commencing a clinical trial, so they are aware and can double-check there are no health reasons why you shouldn’t take part in it.