Thinking about Joining a Clinical Trial? Here’s What You Need to Know

Clinical trials are crucial in advancing medical knowledge and improving healthcare outcomes.  

Monash Health has three clinical trial centres where more than 700 clinical trials are conducted each year. This lays the foundation for medical breakthroughs that change people’s lives in Australia and around the world and will for generations to come. This wouldn’t be possible without our patients, who are our true partners in research. 

So, for individuals considering participation in a clinical trial, it’s essential to understand the process, what’s involved, and the benefits. Having all the information to make an informed decision is crucial to contributing to medical progress while safeguarding personal wellbeing.  

Here’s a comprehensive guide to help you navigate the world of clinical trials. 

Understanding Clinical Trials 

  1. What is a Clinical Trial?

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These trials are conducted to gather valuable data to support new and improved medical practices. 

Director of Research Operations Deborah Dell says that before a clinical trial commences, researchers must demonstrate to a Human Research Ethics Committee that there is scientific rigour behind how the trial will be safe and effective and how they intend to conduct the trial safely and ethically.  

  1. Phases of Clinical Trials:

Clinical trials typically progress through four phases. Phase I assesses safety, Phase II examines efficacy and dose-response relationship, Phase III evaluates effectiveness and balance of benefits and side effects, and Phase IV monitors the treatment’s long-term effects after it’s on the market. 

Benefits of Participating 

  1. Access to Cutting-Edge Treatment

Clinical trials offer participants access to experimental treatments that might not be available through standard care. This can be especially beneficial for individuals with chronic or rare medical conditions. 

“The term clinical trials can invoke a sense of anxiety, but in reality, trials are an effective way to access new treatments in a controlled manner. 

“They can really empower patients to be partners in their own care because joining a trial means going into a partnership between participants and the research team, who are often renowned clinical experts who are across the most recent advances in treatment options,” Dell says.  

Research Manager at the Monash Cardiovascular Research Centre Mary-Anne Austin adds that participants in clinical trials potentially have better outcomes because of the additional monitoring and access to specialist cardiology support. 

“Participants in clinical trials also frequently benefit from the additional health education ensuring a greater understanding of their medical conditions by the end of the study,” she says.  

  1. Contributing to Medical Advancements

Participating in a clinical trial makes you a vital partner in medical research, contributing to developing new and improved treatments. Your involvement may help others facing similar health challenges in the future. 

76-year-old Noel participated in two clinical trials aiming to reduce his lipoprotein (a). He says his experience exceeded his expectations. 

“Things are very organised and smoothly run, with the staff paying great attention to detail. 

“I knew my health would be monitored closely and I wanted to help contribute to future generations, including the health of my own kids,” he says. 

Considerations Before Joining 

  1. Informed Consent:

Before enrolling in a clinical trial, you will be presented with an informed consent form. Take the time to read it thoroughly and ask questions. Understand the purpose of the trial, potential risks, and what is expected from you as a participant. 

Medical Lead of Monash Children’s Clinical Trial Centre, Dr David Metz, adds that clinical trials in children are required to meet higher ethical and regulatory standards than in adults. 

“Because children are a vulnerable group, unable to give fully informed consent themselves, clinical studies of new medicines often only commence once the agent already has proven benefit in adults.  

“There is a higher a priori likelihood that the new medicine will be effective, though studies are still necessary to determine the optimal dose and assess for safety and potential for unique adverse effects,” he says. 

  1. Potential Risks:

While clinical trials prioritise participant safety, there are inherent risks associated with any medical intervention. It is an integral part of the process to be made aware of potential side effects or unknown risks and have the opportunity to discuss them with the research team. 

Dr Metz explains that the robust regulatory framework around safety and effectiveness testing of new medical therapies arose in the 1960s following therapeutic tragedies predominantly affecting children, most notably the thalidomide tragedy. 

However, he adds that children were excluded from this regulatory framework for much of the next four decades, partly due to societal concern that they be used in ‘experimental’ studies and partly due to the perception of there not being a viable market for children’s therapeutics from some industry players.  

“It was only through enormous advocacy efforts from the paediatric community, along with the formation of robust ethical, regulatory and scientific frameworks to minimise risk and burden to children taking part in clinical research, that paediatric drug development became standard at the turn of the century. 

“The evolution of paediatric medicine over the past 50 years has led to the understanding that children are not best protected from research, but rather protected through research, with the mandated additional safeguards to paediatric clinical trials ensuring risk and burden are minimised, and autonomy and vulnerable status respected,” he says. 

  1. Time Commitment:

Participating in a clinical trial often requires time commitment. Participants are advised to consider their schedule and whether they can commit to the required visits, treatments, and follow-up assessments. 

Choosing the Right Trial 

  1. Research the Trial:

Learn about the specific clinical trial you are considering. Understand its purpose, design, and potential benefits and risks. Consult with your healthcare provider to determine if the trial aligns with your medical history and treatment goals. 

  1. Ask Questions:

Ask the research team questions. Inquire about the trial’s duration, potential side effects, and how your data will be used. Ensure you are comfortable and are getting the transparency and communication you need. 

Conclusion 

Joining a clinical trial is a significant decision that requires careful consideration. While it presents an opportunity to access innovative treatments and contribute to medical progress, weighing the potential risks and benefits is also part of a participant’s decision process. Participants are advised to consult with their healthcare provider, thoroughly understand the trial’s details, and make an informed decision that aligns with their health goals. Participation can be of significant personal benefit but could also play a pivotal role in shaping the future of healthcare. 

Mrs M.A.* is one of our current clinical trial participants for treating severe hypertriglyceridemia. In this condition, one has too many triglycerides (fats) in the blood, raising the risk of atherosclerosis (arterial hardening) and related heart disease. 

She has some advice for those thinking about joining a clinical trial. 

Don’t hesitate; the trial may benefit you and others in the future.  Trials are needed to get new medications approved for general use – I tell everyone I know that,” she says. 

Mrs M.A. had suffered side effects from previously prescribed medications such as statins. The 65-year-old participated in the trial for the possibility of receiving medication to help herself and others in the future.  

If you’re interested in participating in a clinical trial, you can visit the Australian Clinical Trials web site here. 

 

Stay up to date with stories and the latest from the world of research; subscribe to the Monash Health quarterly newsletter, Research Matters here. 

* Patient name changed for privacy reasons. 

Approved by: Angus Henderson, General Manager, Research Strategy 



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