How Do Clinical Trials Work?
- Posted by Lele M
- On 18/12/2017
It takes many years of research and testing before medications come onto the market. Evidence is required to show it is safe, and that it works as well as, or better, than current standard treatments. The process of acquiring this evidence is very tightly regulated and involves performing clinical trials. Sometimes, even if a drug has been approved for use by international regulatory bodies, it may still need to be clinically trialled here in Australasia.
Running a clinical trial in New Zealand
To perform clinical drug trials in New Zealand, the study must first be approved by the Health and Disability Ethics Committees (HDEC), of which there are several around New Zealand. Each committee is comprised of medical and scientific professionals, as well as lay people with expertise in other relevant areas (such as law or consumer/community perspectives). Studies investigating unregistered medications must also be submitted to SCOTT (Standing Committee on Therapeutic Trials) for approval. Regulatory approval for a new study may take, on average, between 1 and 3 months.
Even after a study has been approved, clinical research sites may still have to send updated information about the trial to HDEC for approval. For example, there may have been a change in wording in the information sheets given to patients, or there may be a small change in how the trial is being run. These changes are made by the study sponsor, who have designed the study.
The study sponsor, typically a research facility or pharmaceutical company, will usually have several sites in New Zealand (as well as many more around the world) running a trial for their treatment, and they have designed the trial very specifically. It’s not always easy to qualify for a trial! Some may be relatively easy to enrol in, whereas others have a long list of eligibility criteria. P3 is very experienced at finding the right study for people wanting to help us with our research.
Is it safe?
At P3, we only undertake trials with medications that have already been researched at the initial Phase 1 stage. There are four phases of clinical research:
is the first time in humans. These trials are designed to establish the safety of the treatment and the approximate dosing range. These trials are performed in healthy volunteers and patients are extensively monitored following treatment. They typically involve 20-60 people and are typically conducted within a hospital environment.
trials are for people with the disease that the study medication is designed to treat. Phase 2 studies typically involve 50-200 patients and may involve many assessments to look at any effects the treatment has on the body, and how the treatment is absorbed, metabolised and eliminated from the body. Usually a range of doses are tried to look at differences in effect and any side-effects. These studies help researchers find the best dose and dosing interval that has the desired effect.
trials usually involve very large numbers of patients (hundreds or thousands) to identify side-effects that werent seen in the Phase 2 studies and to find out more about the proposed dose and dosing interval. These studies may be performed at out-patient clinics and can take several months (or years) to complete. P3 Research gets its name from this phase!
trials are generally conducted after the product has reached the market. These may involve hundreds or thousands of patients and see how the product is received by the general public. These studies may help identify rare side-effects that weren’t previously documented. These studies may be performed by GPs or other healthcare providers.
How much time is involved for the study participant?
Most studies involve visits to the unit of one to two hours each time; sometimes it’s shorter, And sometimes it’s longer. Every study is different. Depending on the study, visits may be every day, week, month or sometimes longer. The study may last for three months, or a year, or it may last for several years.
Do patients get paid for taking part?
Every participant is reimbursed for reasonable traveling and incidental expenses. If the trial requires a lot of commitment and time, the study remuneration will often reflect this. Every trial is different in this respect. One question some people do ask is if they have to pay us to be in a trial. The answer to that, is no, you don’t pay us!
Why would someone consider being involved in a clinical trial?
There are several reasons why people volunteer to participate. Many people are interested in their condition and learning more about it. They like that they are contributing to medical science and possibly improving their own health while helping to improve the health of future generations. You may obtain access to new and hopefully better medications at no cost. Everyone on a trial receives free, regular check-ups (blood tests, breathing tests, ECG, physical examinations) as required in their trial. Volunteers receive advice on diet, exercise and managing their medication. And, of course, your condition may improve.
About P3 Research
We have three dedicated sites in the North Island: Wellington, Havelock North (Hawke’s Bay) and Tauranga. We employ dedicated, specially trained and experienced doctors, nurses and other staff to care for and supervise volunteers taking part in clinical trials. We have 17 years’ experience in clinical research and have an excellent reputation nationally and internationally.
Compiled by Suzy W.
P3 Research, Wellington Unit, April 201