A clinical trial can be designed in a number of ways. In randomised controlled clinical trials, large numbers of people are recruited to participate in the study. The people who have been recruited are divided by random allocation into two or more groups, so that the groups are similar in terms of age, sex, illness, and other factors that could have an impact on the study results. Each group is given a placebo (a tablet which is not active medicine) or a standard treatment for the disease.
You may have read that many clinical trials are ‘double blind’ trials. This means that during the course of the trial none of the participants, clinical trial staff/study staff know who is taking what, until the end of the trial, and so no one can affect the outcome of the trial in any way. The participants are given study medicine or the placebo/standard treatment, to take in the same way as their family doctor would request. At the end of the trial, the results from the people taking the study medicine are recorded and then compared with the results of the people taking the placebo/standard treatment, using statistical measures. This way researchers can get an accurate picture of what people can expect if they begin taking the medicine.
There is a method called “unblinding” which shows the researchers what trial medication the participant is taking should they need to know because of a side effect.
There is always some risk associated with taking any medicine and there will be an additional risk in taking any new medicines.
If a side effect does occur during a clinical trial and it is decided that it is due to the study medicine, you may choose to withdraw from the study or the doctor may withdraw you from the study. Sometimes the trial is stopped.
For healthy volunteer studies you will be reimbursed for your time and inconvenience at the end of the study. Full payment is conditional on completing the study and complying with the restrictions.
If you are receiving a benefit or allowance from a government agency, there may be implications for this if you participate in the study. You may wish to discuss this with your case manager prior to taking part. The payment advice you receive will state that you were paid from the admission visit until the final follow-up visit. ACS staff are not qualified to provide advice on tax issues.
If you are withdrawn from the study for medical reasons, having received trial medication, you will receive payment in full. If you withdraw for any other reason you may not be entitled to full payment but you will receive a portion of the payment, depending on how much of the study you have completed.
Once you have been accepted onto a study you will be offered taxis to get to and from your visits. There is no parking available at ACS. Metered parking is available on Grafton Road and the Auckland City Hospital carpark is nearby so we can also help with parking and mileage if that works better for you. If you live outside Auckland, we will advise you on your travel payment entitlement.