Several different groups conduct clinical trials, and they are all important. Clinical trials may be commercially sponsored by pharmaceutical companies, or they may be clinician-initiated and publicly funded.
There are many organisations and collaborators that make a clinical trial come to fruition.
Let’s start with some definitions:
What is a site?
A “site” is any place a clinical trial is conducted. Some ‘site’ examples include hospitals, medical research institutes, general practice or specialist clinics and universities.
What is a clinical researcher?
A clinical researcher is a professional who works directly with patients or uses patient data to carry out research on health and disease and develop new treatments. Clinical researchers may also research how healthcare practices affect health and disease.
Clinical researchers can be part of medical institutions, research networks, universities, hospitals, or companies.
What is a CRO?
A Contract Research Organisation (CRO) (sometimes referred to as a clinical research organisation) is a company that provides clinical trial management services to pharmaceutical companies, biotech and medical device companies. The CRO company may help find sites to run studies; design protocols; monitor studies and manage and submit clinical trial data to regulatory bodies for approval. They are essentially the ‘middleman’ between the sponsor and the sites conducting the trials.
CROs may also take on the role of sponsor for overseas pharmaceutical companies to meet the requirement for having an Australian entity. According to Clinical Trials Arena, back in 2010 around one in 10 clinical trials in Australia were conducted by CROs. That number is now one in four.
How clinical trial research happens
Clinical trials are conducted collaboratively by a team of people from each of the aforementioned groups. These teams combine to create a thorough clinical trial execution process, incorporating universal good clinical practice trial guidelines, to ensure safe, ethical and effective trial processes.
There are a number of different reasons why any given institution might conduct clinical trials, and they have varying benefits.
Funding is essential and can come from a variety of sources but pharmaceutical companies provide the bulk of funding for clinical trials worldwide.
One of the main benefits of pharmaceutical-led clinical trials is that their funding power allows them to conduct large-scale studies, and often a large number of studies at any given point in time. As such, they are generally able to find new treatments and answers to research questions more rapidly than other clinical trials.
Some studies are clinician initiated and designed to answer research questions that can support improved clinical decision making and improved practice and outcomes for patients. These studies often rely on publicly funded grants.
Where clinical trial research happens
As described earlier, hospitals, universities and private practices are all sites where clinical trials may be conducted. These can be pharma-sponsored studies or investigator-initiated trials. Clinical trials are a collaborative process run by teams which include doctors, nurses, pharmacists and other health care professionals. The trials are led by a “Principal Investigator” who is usually a clinician or an authority on the condition being researched. This is common across clinical trials.
Phase One clinical trial facilities
Another type of site for running clinical trials are Phase One facilities. They mostly run first in human studies, that often require healthy volunteers. Australia has a lot of different Phase One clinical trial facilities that have helped establish Australia “as a top location for conducting early-phase clinical trials”, according to Clinical Trials Arena. Some of these companies include Nucleus Network, CMAX Clinical Research and Linear Clinical Research. These facilities can also provide local sponsorship for overseas entities and pre-clinical services such as project planning, ethics applications and assistance with TGA clinical trial process etc.
What are Investigator-initiated trials?
Australian Clinical Trials Alliance (ACTA) is the peak body for investigator-initiated clinical trials, which are also known as clinician-led trials. As they explain: “Until ACTA, there was no single, coordinated mechanism to connect clinical researchers with governments, healthcare policymakers and consumers on issues that impact the conduct of investigator-led clinical trials across the Australian health system.” As such, they are crucial for the success of clinical trials across Australia.
Investigator-initiated trials are generally conducted with the aim of comparing existing treatments, and sometimes developing new guidelines for best clinical practice.
Despite the pandemic slowing down or stopping clinical trials completely in some parts of the world, Australia was able to prosper in this area due to our relatively low COVID case numbers. In fact, in 2021 there were actually 27% more interventional drug clinical trials conducted than in 2019.
White Coats Foundation
Want to know more about clinical trials? Check out our What are Clinical Trials blog, or our full list of Clinical trial blogs. At White Coats Foundation, we provide access to credible resources and information to help guide people’s journey in understanding clinical trials and consumer and community involvement in research.
You can also take a look at the list of Australian clinical trial sites
Please note: White Coats blogs are informational only and do not constitute advice. Please contact your relevant healthcare professional for advice on clinical trials for you.