What is tRANSLATIONAL RESEARCH?

TRI’s mission is to improve the translation of innovative research into clinical practice.  To achieve this, TRI provides world-class research facilities; links to clinicians and clinical trial facilities and expertise; links to industry, government and other funding bodies; and an education and training program aimed at producing a skilled workforce for the translational pathway. 

There are challenges to support the efficient progression of developing evidence along the translational pathway. These include the need to link translational research developments back to their origin (discovery science) to ensure continuous medical innovation from discovery in laboratories to preclinical studies. This requires ongoing financial investment through traditional funding sources such as National Health and Medical Research Council (NHMRC), Medical Research Future Fund (MRFF) and the Australian Research Council (ARC).

Another challenge is to support clinician scientists to ensure medical innovations are clinically relevant. For this to occur, there needs to be clinical connectedness between the discovery scientists so that the key questions in the clinic today are being addressed in the basic science laboratories.  This often termed bench to bedside and back to the bench (or B2B2B). 

The important final challenge is to ensure that clinical trial platforms are readily available to support translational research nationally.

Read more about translational research projects at TRI

THE TRANSLATIONAL PATHWAY

 

Approaches to translation

There are a number of approaches to progression along the translational pathway. One approach begins in the clinic where a new diagnostic or therapy is applied to patients receiving health care, which ultimately leads to evidence to support implementation to the broader patient population. 

Another approach is where a discovery leads to early-stage translation (T1), often in an academic research setting.  There are a number of options for progressing from this stage including licensing the development to an existing company or setting up a start-up company and seeking funding.  The start-up company then takes on the role, usually in collaboration with researchers, of progressing the new diagnostic or therapy to the next stage of the translational pathway (T2 and beyond). 

In Australia, we excel in research discoveries and early-stage translation. However, there is a growing realisation of the immediate need to develop the MedTech manufacturing capability nationally. 

Importantly when new diagnostic and therapeutic discoveries are ready for the clinic, careful implementation and evaluation of such new therapies in the clinic are required.  This is an important and evolving area of medical science called Implementation Science which includes the economic and health economic evaluation of new diagnostics and therapies in clinical care.  

TRI’s partners have significant expertise in implementation science and health economics to support evaluation of new evidence into practice.  The harnessing of clinical, pharmaceutical, hospitalisation and other health related data is vital in the consideration of new therapies.  TRI’s partners also have significant knowledge of digital science to support such evaluation.

Clinical trial Phases

Before any new treatment can be prescribed by a doctor it must go through several stages of development to make sure it works, and most importantly that it is safe.

Pre-clinical studies: Prior to giving any new treatment to a human, they are extensively tested in laboratory trials to ensure that they are not harmful. When a drug is thought to be safe, where possible it is trialled in “healthy” people who do not have the disease it is intended to treat, to ensure that it does not have any unexpected side effects.

Phase 2 clinical trials: When a drug is found to be safe, it will be trialled in small numbers of people with the disease it is intended to treat. In general, these studies run for a short period of time and their main purpose is to test that the drug is safe, and work out what dose of the drug should be given. Phase 2 trials may also give an indication of whether the drug is effective but generally they do not run for long enough or include enough patients to determine this. 

These trials often involve a group of people who are taking a placebo “dummy” medication, which is a drug that looks and tastes identical to the actual drug but does not have any of the effects of the “real” drug. This is determined randomly (like tossing a coin).  Neither you, nor the doctor, nor the study team will know which treatment has been assigned to you.  This is done to establish the effectiveness and safety of the real drug.  However, in an emergency, your doctor can find out this information.

Phase 3 clinical trials: Once a drug has been found to be safe and the best dose to be used has been decided, a Phase 3 study will be performed. These studies often involve a larger number of patients and run for a longer period of time. Again, these trials include a group of people taking a placebo. These trials are intended to test whether the drug actually works, and whether it has any side effects from more long-term use.

Manufacturing for clinical trials

“Supporting the MedTech industry through emerging start-up and SME companies to develop their translational pathways locally is now seen as critically important for the future of both translational research development and advanced manufacturing in Australia.”                                                                                                                                                                                                              Scott Bell, TRI CEO.

TRI was visionary when, in 2013, it dedicated 1200m2 of space in the building to support start-up biotech companies. 

As at October 2020, TRI has six start-up companies ranging in size from five to more than 50 employees, with the commercial space being over-subscribed.  These start-up companies utilise sophisticated and specialised core facilities, including good manufacturing practice (GMP) cleanrooms, for manufacturing of medicines or devices for early phase clinical trials.  The companies have access to translational researchers and clinical trial facilities within a tertiary and academic health precinct.

To read more about TM@TRI visit www.tri.edu.au/translationalmanufacturing.

> read more about Translational research Projects at TRI