All new medical treatments must go through the clinical trial process to ensure they are safe and effective. This process can take several years before a medication is approved for wider use. 

Clinical trials are research investigations done on people volunteering to better diagnose, prevent and treat diseases.  

Clinical trials look at how people respond to a treatment and helps to determine the treatment dosing, effectiveness and safety.

Clinical trials have guidelines setting out who can take part. These are known as 'eligibility criteria'. 

To make sure results reflect Australia’s diverse population, it is important that research involves people of all ages, genders and sexualities, as well as people from a wide range of social, economic, racial and cultural backgrounds.

There are many advantages to being involved in a clinical trial or other research study. Depending on the type of research, the benefits may include:

• knowing you have made a valuable contribution to helping others in the future
• joining programs or having medicines or other treatments that are not readily available outside of the study and may be better than the current standard treatment for that disease
• getting access to expensive drugs that your specialists recommend but that are not currently supported by the Pharmaceutical Benefits Scheme (PBS)
• seeing your treatment team, including specialists, more often
• taking an active role in your health care
• learning new ways to improve your lifestyle
• improving or maintaining your quality of life
• feeling that you have tried all treatment possibilities.

Taking part in research doesn’t always mean you will be better off than before or compared to other people in a similar situation. Some people may not respond in the way researchers hope and will not benefit from being involved in the research.

Your doctor and the clinical trials or research nurse will discuss the possible advantages and disadvantages for you before you join a research study.

Understandably, people want to know if there are any risks to taking part in research. Researchers must follow strict guidelines to make sure clinical trials are as safe as possible for everyone involved. This is called their 'duty of care'.

Before any research involving people can begin, it must be approved by a special group known as a human research ethics committee. As part of this process, researchers identify risks that might occur, such as possible side effects.

Before you agree to take part in research, you must be told about these risks, how you will be monitored for problems, and what will be done to help you if problems occur. To reduce potential risks, clinical trials are arranged in a series of steps known as phases.

Anyone taking part in a trial must be fully informed about the aim of the research, what is expected of them and any risks and potential inconveniences that may be experienced during and after the trial. 

Everyone taking part in a clinical trial must give ‘informed consent’. Informed consent is a decision, given voluntarily, to agree to a healthcare treatment, procedure or other intervention. It means that before you decided whether to take part or not, you:

• considered information about the clinical trial and alternative options available
• understood the benefits and risks of the clinical trial for the person who would be participating.

To help you decide whether or not to be part of a trial:

• members of the research team will explain the trial to you
• researchers will give you a participant information and consent form, that includes details about the research project such as its purpose, duration, required procedures, risks and potential benefits
• you will be provided the opportunity to ask any questions that are not clear to you or that you do not understand
• take your time and talk it over with family and friends or your own doctor.

You will then decide whether or not to sign the consent document. Signing the consent form means that you agree to take part in the trial and understand what that will involve.

The consent form is not a contract, and you may withdraw from the trial at any time. If you do withdraw from a clinical trial, it will not affect your routine health care or your relationships with the researchers or your doctor.

Researchers must let you know if there are any changes to the trial or to the protocol. If this happens, you may need to give your consent again before proceeding with the trial.

All clinical trials follow a carefully controlled protocol (plan) that describes what researchers will do in the study. 

As a clinical trial progresses, researchers may report the results of the trial at scientific meetings, to medical journals, and to various government agencies. When they do this, the names and personal details of trial participants are kept confidential and are not disclosed.

Clinical trials are conducted by a wide range of organisations. They include:

• Publicly funded research organisations such as universities and teaching hospitals;
• Private research organisations under a grant from the government’s National Health & Medical Research Council or from public donations;
• Pharmaceutical companies, either solely or jointly with other research institutions such as universities and hospitals.

Regardless of the type of organisation sponsoring the clinical trial, the clinical trial must be approved and monitored under the ethical and good clinical practice guidelines set down by the Australian government.

Clinical trial participants may be reimbursed for travel and parking costs. Healthy volunteers and early phase patient studies may be paid for their time.

Clinical trials in Australia are regulated by laws and Codes of Conduct that aim to protect the rights, safety and wellbeing of all trial participants as well as ensure the integrity of the research. 

All clinical trials in Australia must be approved by a Human Research Ethics Committee (HREC). 

Each trial conducted at Novatrials is reviewed by an independent, certified, HREC. 

A HREC reviews the  study to ensure the rights, safety and wellbeing of everyone involved in the trial (this includes the secure use of data).  

At Novatrials, our trials are run by a team of highly trained health professionals, with each trial led by a General Practitioner (GP) or other clinical specialist (Dr) and supported by a team of nurses, ambulatory specialists and scientists. This ensures you are well cared for every step of the way, at no cost.