About clinical trials

Clinical trials are medical research studies used to compare two or more treatments.
The trial participants are randomly divided into two or more groups - one or more groups receive the experimental drug, device or intervention and at least one group receives the comparator e.g. standard care or placebo.
Each trial participant is followed up so researchers can measure the results of each treatment.
Clinical trials provide the most compelling evidence about the safety and efficacy of an intervention and are thus a critical component of evidence-based medicine.
Our centre specialises in clinical trial innovation. Our team of experts will find the best clinical trial method for your needs whether this is a traditional parallel, crossover or sequential trial or an innovative trial method such as basket, adaptive, platform, umbrella, pragmatic, decentralised or cluster cross-over trials.
Clinical trials investigating unapproved medications or new indications for approved medications are split into four phases. Our Centre can provide expert advice or support for all four clinical trial phases.
Phase I
- first in human studies
- evaluates safety
- requires approximately 15 - 80 clinical trial participants
Phase II
- evaluates efficacy and safety
- requires approximately 100 - 300 clinical trial participant
Phase III
- evaluates efficacy, side effects, dosage responses and safety
- can be used to compare existing and new treatments
- requires approximately 1000 - 3000 clinical trial participants
Phase IV
- monitors safety of an approved medication once made available to the general population
- evaluates long-term benefits and side-effects and optimal use in the general public
Clinical trials can be funded in several ways including:
- Government grants e.g. NHMRC, MRFF
- Pharmaceutical companies
- Charities e.g. Cancer Council
- Universities and research institutions
- Philanthropic organisations
A protocol sets out the rules and plans for conducting a clinical trial. It ensures the trial is safe and effective. A study protocol is reviewed and approved by a Human Research Ethics Committee (HREC) before a clinical trial can commence.
The protocol should include:
- the aims of the trial
- planned research methods, tests and procedures
- recruitment procedures and participant eligibility requirements
- methods for assessment of participant events
- data analysis approaches.
A clinical trial team can include doctors, nurses, other healthcare professionals, social workers, biostatisticians, trial coordinators and monitors.
We help research groups build their clinical trial team.
All clinical trials must be approved by a Human Research Ethics Committee (HREC) before they begin recruiting participants. A HREC is an independent group consisting of health professionals, medical researchers, pastoral care workers, lay people and lawyers. They ensure research follows the NHMRC National Statement on Ethical Conduct in Human Research 2023, Good Clinical Practice guidelines and the ethical principles of the Declaration of Helsinki.
Our Centre can guide clinical trial teams through the mandatory ethics process.
Many clinical trials require a DSMB to monitor the trial and advise if any safety issues occur during the trial. The DSMB is an independent multidisciplinary group.
Our centre assists groups in establishing a DSMB for their clinical trials.
Once the trial period for a clinical trial is completed, the work begins on analysing all of the data to determine if the intervention is safe, effective and implementable. Our centre is able to support clinical trial teams to analyse and report on their clinical trial data. As an Academic Research Organisation, our Centre can assist in the drafting clinical trial manuscripts for publishing in scientific and medical literature, or reports as required for inclusion in a commercial application.
Please find more information for participants and consumers here.

Monash University Clinical Trials Centre (MUCTC)

Medicine, Nursing and Health Sciences

About clinical trials