Home / How are Participants Protected during Clinical Trials?
Clinical research and clinical trials are an incredibly important part of a lengthy process to bring new drugs and medical procedures to market. In earlier articles we have described the process drug companies must follow to bring a new drug to market and we have also talked about the regulatory bodies that control ethical issues and monitor safety.
So, how is the safety of patients in clinical trials in NZ monitored and evaluated? What methods are used and what information do they require? What happens around getting people’s consent and providing people with information? And what happens if things don’t go according to plan?
A participant’s safety is the number one priority in any clinical study. There are safety protocols and checks all the way through the trial process.
Before any clinical trial can start it must firstly be approved by HDEC (the Health and Disability Ethics Committee) and Medsafe (the New Zealand Medicines and Medical Devices Safety Authority).
Once this approval has been received, NZCR can begin to recruit participants for the clinical trial. Depending on the investigational drug being tested, there are often special criteria the research team are looking for such as age, gender, medical history, BMI and other factors.
Potential participants are contacted and undergo a more thorough assessment of their suitability for a trial. Each potential participant is provided with a study-specific information sheet, which sets out why the medical trial is being done, what their participation would involve, what the benefits/risks might be, and what happens when the trial is over.
A qualified doctor discusses the information sheet with the participant in more detail and answers any questions they may have. If the participant decides to take part, they will then need to sign the consent form before they undergo the screening process to determine if they may be eligible or not. It is important to note that a participant can withdraw from a study at any time for any reason.
Once the clinical trial is underway, the safety data is reviewed by the NZCR team on an ongoing basis throughout the duration of the study to ensure participant safety.
This includes the results of:
Each clinical study has a specific set of stopping criteria in place as a precaution. These criteria are trial-specific and outline the conditions under which the clinical trial (and recruitment) must be stopped or paused so that further investigation can happen. This is closely monitored by clinical staff throughout the study.
If any changes need to be made to the study, for example, adjusting the dose of the study drug, this change must be reviewed and approved by the HDECs and MedSafe before it can be implemented. Once approved, this change would be discussed with the participants in detail and the participant would need to provide their consent again to continue with the study.
After leaving the trial facility, participants normally have regular follow-up appointments with the medical trial staff to check their health and collect data. These follow-up visits vary depending on the requirements of the study trial they participated in.
There are significant checks and balances undertaken before, during and after every clinical trial. Clear and open communication with trial participants is paramount with the need for participants to feel safe at all times and have any concerns addressed. As mentioned, a participant can withdraw from a study at any time for any reason.
New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.