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There have been plenty of conversations about vaccinations and how quickly they have been developed in response to Covid-19. Perhaps it has got you thinking about the processes for clinical trials, how safe trials are, and what regulations are followed in New Zealand?
You’ll be pleased to know that NZ provides a world-class system for regulating clinical trials and our practices are in line with the gold standard set out by the European Medical Association for best clinical practice.
So, how does a clinical trial get approved in New Zealand?
Before a clinical trial can start in NZ, it must go through the Ministry of Health, which ultimately means an approval from the Director-General of Health (currently Dr Ashley Bloomfield). The Ministry of Health will make sure both the medicine and the way the trial is to be run, meets all the requirements of the Medicines Act.
Prior to the Director-General of Health approving a study, a number of other processes must happen:
1. The science and research are checked thoroughly
Medsafe are NZ’s Medicines and Medical Devices regulatory authority - whether it’s a new antibiotic or a novel hearing aid being tested, Medsafe are responsible for checking and approving the science behind the medicine.
So, before you can take a medicine in a trial, the evidence for that medicine (or device) will have been thoroughly reviewed by the team at Medsafe. They need to be happy that all the data stacks up (e.g the medicine is safe enough, it works well enough and is of a high quality) and the medicine is appropriate for the trial that has been proposed.
The processes for how the medicines are manufactured, stored and distributed are all included too.
Once the review is completed, Medsafe provide the information to the Health Research Council of NZ. They consider the application and make a recommendation to the Director-General of Health.
2. People participating will be well informed and protected
In addition to checking the science behind the new medicine, any clinical trial must also receive Ethics approval. You might be wondering what sort of ethical considerations take place?
For example, the ethics committee check that;
- the trial has been designed well enough so that when it is completed the data can tell us whether the new medicine works or not.
- the information provided to those taking part is easy to understand and covers everything the patients (and in some cases their carers) need to know.
- there is a consent process in place. Anyone participating must be fully informed before they give their consent to start a trial.
For the most part it is the Health and Disabilities Ethics Committee (HDEC) who review the ethical aspects of a trial.
Once both MedSafe approval and Ethics approval have been given, the Director-General of Health is able to approve for the trial to take place in New Zealand.
Good Clinical Practice Standards
Once a trial starts, the site of the trial will be responsible for ensuring Good Clinical Practice Standards are followed. These put the participant at the centre of all considerations. One of the fundamentals of good practice is that the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
All clinical trials in New Zealand are expected to be conducted in accordance with internationally accepted Good Clinical Practice standards. New Zealand has adopted the European Medicines Act guideline for good clinical practice. You can find more information on these standards here.
“I was given the utmost care by everybody at Optimal”
While we follow all the regulations set out for clinical trials, we also have our own very high standards. All staff complete training on Good Clinical Practice before working on a study and we go above and beyond to make sure every trial participant has the best possible experience with us.
We are proud to have received so many positive comments from our patients about their experience on our trials. Click here to read a patient's story.
If you are interested in taking part in a clinical trial, check out our Open Trials or complete a form with your details and we’ll alert you when we have new research opportunities.