What are Clinical Trials

Purpose

Clinical trials are studies designed to establish the safety and efficacy of new medical treatments, with the goal to improve the quality of life for people suffering from diseases, and in many cases, save lives. When conducted and completed effectively, clinical trials ideally result in new drugs, diagnostic tools and clinical procedures being developed for current and future patients. Additionally, clinical trials have the added benefit of revealing more information about the given diseases being studied. The studies conducted often lead researchers to questions they had not considered yet.

Clinical Trial volunteers

In order to be possible, clinical trials require volunteers. However, these volunteers also need to meet specific eligibility criteria to be able to part-take in the trials. The eligibility criteria for each given trial is highly dependent on the individual study, and the parameters researchers decide they need to conduct their research vary. Things like gender, age, or health status can all be contributing factors to whether a volunteer is eligible, and in many cases the volunteer will need to actually have the given disease or condition to be eligible.

The good news though, for people who are determined to be part of a trial, is there are many different clinical trials, and some of these require healthy volunteers. There are many reasons why you might want to participate in a clinical trial as a healthy volunteer. Plenty of  people have seen family members benefit from previous clinical trials, and might be motivated to give back as a result. Or you might simply be determined to participate in the process of medical research for altruistic reasons.

You can search for trials at ANZCTR, and you can  register to receive clinical trials alerts through the Australian Clinical Trials Government website.  You can also find other clinical trial resources to access current clinical trials on our website.

Many people who participate in clinical trials do so because they are already afflicted with certain diseases. In these cases, often a helpful benefit of being part of the trial is that the given treatment might help improve the patient’s condition. Additionally, being part of a trial often comes with added benefits, like care and treatment costs being waived.

However, it is of utmost importance that every volunteer be made aware of all known possibilities before signing on to a clinical trial. The nature of a trial is to investigate the uncertain, and as such, there is no guarantee the results will affect the participant positively. It should also be remembered that clinical trials require a lot of commitment. There may be weeks, months or even years worth of treatments, which requires dedication. In addition, participants have to provide informed consent before taking part in a trial, which means they have to be thoroughly briefed, or ‘informed’, before being able to participate. An informed consent document will be provided that explains the purpose of the trial, the details of all procedures to be undertaken, and the risks and potential benefits.

Additionally, in Australia all clinical trials need to be reviewed and approved by an ethics committee and registered with the Therapeutic Goods Administration before patients can participate.

How do Clinical Trials work?

Clinical trials are conducted with variable conditions. For example some require that participants are not given the treatment, and others are. In these cases, it is often required that whichever group participants are placed in is randomised, so as to avoid the possibility of biased selections. This is common practice for late-stage clinical trials. In these trials, one group will receive the standard treatments or placebos (which are inactive substances, with no therapeutic value) however, belief in the treatment may lead to a measurable and positive health response. Those receiving placebo are known as the ‘control group’. The group receiving the trial treatment are known as the ‘treatment group’.

Not all clinical trials are aiming to simply find new treatments for existing diseases. They can often help add extra interventions to existing treatments. For example, research will combine new interventions with existing ones and observe the results. In a similar structure to the ‘treatment group’ and ‘control group’ scenario, half of the study’s participants will receive the standard and new treatment, and the other half will also receive the standard treatment as well as a placebo. The placebo is designed to look the same as the new treatment, but does not contain the new ingredient.

Whilst participants are able to leave a clinical trial whenever they like, it is highly recommended that they do so in consultation with a medical professional who is familiar with the trial. There are many different possibilities when treatments are suddenly stopped, and having the best information when leaving is essential.

Benefits of Clinical Trials

Finally, we should consider some of the incredible benefits of clinical trials. Many medical procedures have been made possible by clinical trials, whether they be surgical, or related to medical treatments. Clinical trials have also been essential to developing many different vaccines that have limited the worldwide spread of deadly diseases.

Remember, all treatments we have today, even the standard antibiotics and painkillers, had to be trialed before being approved for generalised use. The more clinical trials that are conducted successfully, the healthier our planet will be.

Get involved in Clinical Trials

If you are interested in being part of a clinical trial or would like to learn more about them, you should take a look at our Participant Stories. Additionally, being a participant in a clinical trial is not the only way patients and consumers can contribute to medical research. There are other ways to be involved which might include contributing to asking the right research question or influencing the protocol design of a study. To learn more about consumer involvement in research click here or download our reflections paper.