Clinical Trials Day spotlight: The role of clinical research

This Clinical Trials Day we chat with Sonya McColl – Head of Research here at GenesisCare.

Sonya brings over 30 years of expertise in healthcare, clinical research, and executive leadership. From her early career as a Registered Nurse in both Australia and the UK, she transitioned to clinical research in 2002, founding her own research consultancy in 2010.

Now Head of Research at GenesisCare, Sonya has played a pivotal role in establishing national research networks in both cardiology and oncology, and leads a research team of over 55 staff, across 50 sites and 150 projects.  

Setting up my own research consultancy back in 2010. I worked with a start-up called Ellume in Brisbane where we designed and rolled out their very first trials using a point-of-care digital diagnostic device to diagnose influenza. This company went on to be the first rapid COVID-19 self-test to be granted Emergency Use Authorisation by the FDA without a prescription.

I just sort of fell into it like most people seem to do. I was working as a coronary care nurse in Brisbane and noticed that the cardiologists were involved in clinical trials. I was very interested, so starting working with them part-time which ultimately led to me leaving nursing and working full-time in clinical trials and then setting up and managing the Wesley Research Institute Clinical Trials Centre.

GenesisCare undertake two main types of research projects:

• Interventional: Where we look at new treatments and medications
• Observational: Where we look at health outcomes over time

We also do some projects that are more focused on reviewing and analysing retrospective data and publishing the results of those findings. 

We are currently involved in over 150 clinical trials and research projects across our sites in Australia in the areas of radiation oncology, medical oncology, haematology, theranostics and precision medicine.

Patients are key to our trials, and numbers matter as trials have eligibility criteria that not all those that apply will meet.

Patients can become aware of a clinical trial through their healthcare professional, via the internet, social media and various consumer and trial groups, such as Breast Cancer Trials or Rare Cancers Australia, and government bodies such as the ANZCTR. GenesisCare provides information on clinical trials and a listing of trials where we are actively looking for patients to join.

You can determine if you are eligible for a clinical trial by checking the trial's inclusion and exclusion criteria (e.g. your age, diagnosis, current medications etc).  Your health professional will help guide you through this process.

There are many benefits of participating in a clinical trial, including:

• access to research treatments before they are widely available
• playing an active role in your health care

And then there’s the greater good - you are helping others by contributing to medical research.

Clinical trials are essential for evaluating the effectiveness and safety of medicines, devices, services and interventions to help prevent, identify or treat illness and disease. It is through the research done on clinical trials that people gain access to better treatments. If more people take part in clinical trials, it may reduce the time it takes to make new interventions widely available. In some cases, your own health or that of others with the same disease or condition might improve.

There are no costs to taking part in a clinical trial.  

GenesisCare supports access for patients from all parts of Australia. Those in regional/rural communities and indigenous peoples have equal opportunity and access to our clinical trials. We have a number of research sites in regional areas and are also adopting remote research practices to assist in broader access. Sponsors of clinical trials also offer reimbursement to cover the cost of travel and accommodation for trial participants for their appointments.

Medical advances are accelerating the battle against cancer through clinical trials. One exciting advancement is the personalised medicine space and biomarkers (an objective measure that captures what is happening in a cell or an organism at a given moment). Improved biomarkers can enhance the accuracy of cancer diagnosis and treatment through enabling oncologists to tailor treatments based on the unique molecular profile of each patient's tumour. Future oncology treatments will be specifically tailored to individuals and their biomarkers, and this is exciting! The aim is to increase efficacy of treatment and reduce side effects.

Throughout my nursing and research career, I believe the area where I’ve made the most significant impact is in oncology research. Clinical trials are often the final option for patients with cancer, and being able to offer this opportunity and bring some hope to their lives is truly rewarding.