News & Events

20 May 2019

Accepting Uncertainty in Clinical Trial Research:
An Interview with Prof Andrew Davidson on International Clinical Trials Day

 

Scottish surgeon James Lind is often credited, in an apocryphal story perhaps, with having conducted the world’s first clinical trial. In 1747, aboard English gunship the HMS Salisbury, Dr Lind treated a small group of sailors so weak they could barely stand. Working on a medical hunch, he controlled some variables and within days the few he purposefully treated with oranges and lemons were back on their feet, while the rest only got worse.

We’ve come a long way from the menace of scurvy on decks of the HMS Salisbury, but the spirit of clinical trialling remains the same. And today, on International Clinical Trials Day, we ask: where to from here?

 


 

The world of clinical trial research is entering a new greyer era, according to Prof Andrew Davidson, MACH Clinical Trials Subcommittee Chair. But that’s not a bad thing. Indeed, it’s possibly one of the biggest advances of the decade.

Prof Andrew Davidson is a world leader in clinical trials. As the Medical Director of the Melbourne Children’s Trials Centre at the Royal Children’s Hospital and Murdoch Children’s Research Institute, you can often find him at the helm of landmark trialling.

Also acting as Senior Staff Anaesthetist and Professor in the Department of Paediatrics at the University of Melbourne, Prof Davidson usually runs trials with children as the subjects – an added hurdle in an already complex field. Despite the potential benefits to both patients and medical science, recruiting patients for clinical trials is notoriously difficult, even for someone of Prof Davidson’s reputation. Much of the general public doesn’t understand what clinical trials are all about, and often equate them with pharma companies testing new pills in order to make a buck. In fact, while drug-based clinical trials are an important component of the CT world, vastly more clinical trials worldwide are funded by universities and government bodies, as opposed to industry[1]. Clinical trial information is also public and transparent by nature, and trials touch all areas of health, from genomics to motor neuron diseases, devices and behavioural therapies, and beyond. Most novel interventions for conditions such as cancer, heart disease, and asthma are a direct result of clinical trial research, according to the Australian Clinical Trials office of the Australian Government[2]. The benefits to the health of a population cannot be understated.

From 2007 to 2018, Prof Davidson conducted a landmark study strongly supporting the theory that general anaesthesia in infants is unlikely to cause neurodevelopmental or behavioural problems in children as they grow. The study, which was the first of its kind, provides the strongest evidence yet that short-term exposure to general anaesthesia is safe in infants. Results of the study were recently published in the Lancet, and its potential impact worldwide is immeasurable.

"Nearly half the general anaesthetics given to infants are used for less than one hour, therefore our findings should reassure health professionals and the millions of parents whose young children undergo surgical or diagnostic procedures with anaesthetic drugs worldwide every year," Prof Davidson told the Lancet[3].

The MACH’s efforts to support such game-changing clinical trials are growing. The centre currently employs a Clinical Trials Manager, who works with Prof Davidson and the Clinical Trials Subcommittee to drive innovative research and collaboration across its members. Connecting researchers and clinicians makes the process of trialling more streamlined and speeds up the process of getting clinically important findings from trials into practice, to the benefit of patients. There are several new advances which are changing the trial landscape in Melbourne, according to Prof Davidson. Firstly an increasing number of hospitals, both in Melbourne and beyond, are using digital records.

“It makes it easier for us to embed trials in clinical practice, easier to compare treatments for effectiveness, and makes it cheaper because we can use existing data,” he said.

The hospitals and research institutes under the MACH umbrella also have access to a wealth of expertise in biostatistics. As trial science progress and clinical trials become more and more complex, building capacity among those who can do advanced data modelling is becoming increasingly important, Prof Davidson noted.

“Smart trials that use advanced modelling can compare multiple interventions in multiple populations so, as trials progress and patterns emerge, you can drop things that don’t seem like they’re going to work and concentrate on things that do,” he said.

But perhaps the most exciting thing to come in the world of clinical trial research isn’t hard and fast results, but the opposite – increasing uncertainty – and a move away from the black and white thinking of the past into a world where grey areas are the expected, and accepted, norm of clinical trial results.

In the past, those who interpret clinical trial data have tended to make firm statements about results – X is better than Y, or A is the same as B, for example. While the clinical data underpinning these results are certainly correct, the interpretation has been too black and white, according to Prof Davidson. A recent paper in Nature called for all clinical researchers to fundamentally change the way they report data. It was endorsed by over 800 world leaders in clinical research and biostatistics. 

“The thing we’re coming to understand is that there is a degree of uncertainty in any clinical research owing to the fact that you’re dealing with complex people and diseases,” he said. “By applying a more tempered lens, you can stack building blocks of evidence to find out what’s likely to work,” and intentionally expand upon that knowledge through multiple trials, he said.

While Prof Davidson admits that in the future headlines about medical breakthroughs won’t be as exciting, it’s an easy trade-off if it means more meaningful statements about treatment and, ultimately, healthier Australians.

[1] Source: Australian New Zealand Clinical Trials Registry website: www.anzctr.org.au. Statistics showing number of registered trials by type of funding source, active 1 Jan 2017 to 30 April 2019: University (1,102), Government body (924), Commercial sector/Industry (821), Hospital (803)…(14 May 2019)

[2] Source: Australian Government, National Health and Medical Research Council, Department of Industry, Innovation and Science website: https://www.australianclinicaltrials.gov.au/what-clinical-trial (14 May 2019)

[3] Source: Eurekalert Public Release: https://www.eurekalert.org/pub_releases/2019-02/tl-pss021319.php (14 Feb 2019)

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