Students in Focus
From regulator to researcher: helping shape the future of clinical trials
Only one medical student would get the chance to be allowed into the operating theatre – but first, the group of students was asked to calculate the exact angle at which a probe would need to enter the patient’s brain.
Anastasia Makshakova got it right. That day, she got to observe a cryosurgery procedure for a patient living with severe Parkinson’s disease and later, saw the patient without the tremors that had previously permeated every aspect of their day-to-day life.
It was a moment that sparked a lifelong fascination with medical technology and the systems that help bring it safely to patients.
For Anastasia, now a Â鶹´å of Canberra PhD candidate, improving healthcare has never been about following a single career path. Instead, it has been about understanding the system from every possible angle.
Over two decades, that curiosity has taken her through the fields of medicine, pathology, clinical trials, healthcare regulation – and now, research.
It has also earned her a seat at the table, helping to shape the standards that underpin the safety and quality of medical devices.
Recently appointed to Standards Australia’s Technical Committee HE-030 Biological and Clinical Evaluation of Medical Devices, Anastasia will contribute to the development and adaptation of standards that guide clinical investigations involving medical devices in Australia. This includes work related to the internationally recognised ISO 14155 standard, which sets international best practice for medical device clinical trials.
For her, the appointment is an opportunity to improve healthcare beyond the clinic.
“When we get standards right, we set our industry up for success. Standards establish expectations, define acceptable levels of risk and help ensure medical devices are safe and effective,” Anastasia says.
Her interest in the systems underpinning healthcare began early.
As a medical student, Anastasia was struck not only by what medical technologies could achieve, but by the precision, knowledge and safeguards required to use them effectively.
“Seeing that patient [with Parkinson’s disease] after the surgery, with no tremors, really cemented my fascination with medical technologies,” she says.
“But it also made me curious about everything happening behind the scenes – how these technologies are developed, tested, regulated, and eventually reach patients.”
That curiosity continued after she moved to Australia from Russia, where she deliberately built experience across different parts of the healthcare system.
Anastasia worked in pathology laboratories, pharmaceutical manufacturing and clinical research, giving her insight into the many people, processes and decisions involved in bringing health products and technologies to patients.
Eventually, that experience led her to the Therapeutic Goods Administration (TGA), where she joined Australia’s developing Good Clinical Practice inspection program.
Anastasia progressed from Associate Good Clinical Practice Inspector to Lead Inspector in just a few years, contributing to several milestones, including Australia’s first regulatory inspection of a medical device clinical trial.
“I loved being an inspector because of the real-world impact of the role and the opportunity to collaborate with global experts,” she says.
“But the more I worked in regulation, the more questions I had about how we could make the system even better.”
Those questions eventually led her back to university.
To pursue research into Australia’s regulation of clinical trials, Anastasia made the difficult decision to leave the TGA, because of an unavoidable conflict of interest between her role and her proposed research.
“It was a very difficult decision to resign, but I felt this research was too important not to be done,” she says.
Now undertaking a cross-disciplinary PhD through UC’s Faculty of Business, Government and Law (BGL) and Faculty of Health, Anastasia is exploring how Australia’s clinical trial regulations can become more efficient, while continuing to protect patients.
Her research is still evolving, but its purpose is clear.
“I’m looking for ways to make regulation of clinical trials both more efficient and more effective,” she says.
The interdisciplinary nature of her PhD has become one of its greatest strengths.
Anastasia initially approached the topic from public health and regulatory science perspectives, but soon realised meaningful regulatory reform required expertise beyond health alone.
“I realised I couldn’t actually improve clinical trial regulation without understanding regulation itself more deeply,” she says.
“My supervisors across Health and BGL have helped me bring those different perspectives together. It’s a great example of the opportunities that exist at UC.”
Her professional experience and research continue to inform one another.
Alongside her PhD research, Anastasia works in the clinical trials sector at Canberra Health Services (CHS) and serves on a Â鶹´å of Canberra Human Research Ethics Committee.
“My professional experience helped me identify the questions I wanted to answer,” she says.
“Research has helped me ask better questions, see new connections and focus on what really matters. It’s all connected.”
As a member of Standards Australia’s Technical Committee HE-030, she will have the opportunity to share her technical expertise, contribute to decisions about medical device standards and help consider where international standards may need to be adapted for the Australian context.
“Being able to contribute while I’m still doing my PhD is incredibly exciting,” she says.
“I don’t have to wait until I graduate to have real-world impact. I can also learn from the other experts around the table, and that will strengthen my research.”
Medical device regulation is becoming increasingly complex.
The sector now includes not only physical products and implantable technologies, but also software-based devices, data-sharing systems and technologies, which means that privacy and cybersecurity risks must be taken into account.
For Anastasia, that complexity is part of what makes the field so important.
“What excites me about medical device clinical trials is the amount of innovation that is happening and how closely many of these technologies respond to individual patient needs,” she says.
“I want to be part of enabling more innovation, with the appropriate safeguards in place.”
Looking ahead, Anastasia hopes her work will contribute to a regulatory system that protects patients while supporting safe, effective innovation.
“My hope is to help create regulatory requirements that are straightforward, future-proofed and that remove unnecessary barriers,” she says.
“I also want to better understand the challenges industry faces, to inform my research.”
After a career built on asking questions and seeking new perspectives, Anastasia has one piece of advice for professionals considering returning to study.
“Keep learning,” she says.
“We live in a time when learning has never been more accessible. Every course I’ve taken has opened another door, and eventually that journey led me to a PhD.
“I’d encourage people to keep asking questions, keep building their knowledge and sharing what they learn. The world needs it.”
Words by Jonathan Le Bourhis. Photos: provided.