Is it safe to participate in a clinical trial?


Amelia suffers from eczema and has done for most of her life. She has two children with eczema and wishes for their lives to be less impacted by the condition. For this reason she has chosen to participate in a clinical trial, in the hope that it will provide better treatment options in the future for her children.

Tama has been diagnosed with Pancreatic Cancer. He has been told patients who participate in clinical trials have better outcomes. With few current treatment options, Tama is keen to have access to the latest developments to treat his cancer.

Like Tama and Amelia, there are many New Zealanders interested in participating in clinical trials. The reasons are varied, but the first question is almost always “Is it safe?”.

Dr Barney Montgomery, Managing Director of Optimal Clinical Trials says “There is always some risk involved when taking medicine or using a medical device – even the likes of Panadol has potential side effects. However, there are multiple processes to ensure safety is always the top priority.”

Significant Research and Development

Before a new treatment can be tested by people, it goes through years of research in laboratories. Studies must provide in-depth data to prove the treatment’s safety and efficacy profile. The study must pass an ethics committee review before it can proceed to the next phase.

Approval is required by the Director-General of Health

In New Zealand, before a clinical trial can commence, it is reviewed by Medsafe, the Health Research Council and an Ethics committee before approval is given by the Director-General of Health. This ensures a robust review of the clinical trial before it is approved to go ahead in New Zealand.

Informed consent

Each person who chooses to participate in a clinical trial signs an informed consent before they start. This means the person is fully informed about the trial and can make a decision to participate based on all the information. Time is taken to fully explain the trial including what the treatment regime will look like, how long it will take, how they will be monitored, any additional testing that might be done and any potential side effect.

Before signing their informed consent, a participant can ask any questions and can choose not to participate at any point.

Clinical trials have specific eligibility criteria

Trials are carefully designed to specify which patients can and cannot participate. Participants are carefully screened before the study and might be excluded due to their age, other medicines they are taking or due to a pre-existing condition.

Participants are carefully monitored

Careful monitoring happens for all participants on a trial. The medical team carefully watch and measure progress, and participants are encouraged to report any new or worsening side effects. This allows the healthcare team to manage any side effects or make adjustments to the treatment The data is also an important part of the information collected by the trial.

Dr Liz Smaill, General Manager at Optimal Clinical Trials says “We know that positive change happens in the medical field because of the people who choose to participate. We have the greatest respect for those who consider it. When someone joins Optimal as a volunteer, they become part of our research family and we look after them as such.”

If you are interested in participating in a clinical trial now or in the future, we’d love to hear from you. Our friendly team will be more than happy to talk to you about on-going trials or answer any questions you have.

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