Lab Research - Clinical Trials

It’s when a team of scientists and doctors tries a new medical treatment, drug, device, or method on a group of people to test how well it works. The purpose of a clinical trial is to find a new and improved way to treat, prevent, or diagnose different types of illness. In many cases the trial might be for something that is not yet available to the general population of people with an illness. Special allowances are made so doctors can learn more about how well a new approach works. They test the results against the best available current treatments with the goal of finding something better. This could be especially useful if you have a serious illness and have run out of effective standard treatments. Scientists first test these new treatments with laboratory experiments. Next, they try them on laboratory animals. Only when they deem them safe and useful enough in these early stages does a clinical trial start on people -- first in small groups and then in larger ones. Clinical trials help doctors discover the answers to these questions: Is the treatment safe and effective? How well does the treatment work? Is the treatment potentially better than the treatments we have now? What are the side effects and risks of the treatment?

There are several stages, or “phases,” of a clinical trial. Each new phase builds on information from previous stages. You might qualify for a certain phase of a trial because of the state of your health or the seriousness of your particular illness. People who take part usually do it in phase III or IV of the trial.

Drug Discovery Phase – This phase takes place in the laboratory, where scientists use various experiments to discover new drugs which may be effective at targeting a specific disease or ailment. This research usually takes between 3 to 5 years as the drug needs to be identified before it can be tested. Preclinical Phase – This phase also takes place in the laboratory, however at this point the treatment has been developed and the researchers are now testing it on either human cells or animal models. Preclinical research usually takes about 1 to 2 years and aims to ensure the treatment is both useful and safe. Phase I Clinical Trial – This is where the researchers begin to test on humans to understand how the treatment effects them directly. Up to 10 human participants can be tested on at this point and this can take around 1 year. Phase II Clinical Trial – If the treatment passes phase I clinical trials, it can progress to phase II. This involves testing the treatment on 20 to 50 participants for around 2 years. The aim of this phase is to evaluate the safety of the treatment and how effective it is for human use. Phase III Clinical Trial – In order to confirm the benefit and safety of the treatment, it must progress to phase III clinical trials. This phase takes 1 to 4 years to complete, and the treatment is tested on 100-200 participants at this point. If the treatment passes this phase it is usually deemed to be safe and beneficial for human use. If the trial is successful, the regulatory authority (such as the HPRA) grant the researchers a license to market the product. Phase IV Clinical Trial – At this point the treatment has been released to the public and is being used by 200+ people, however it is still being monitored by the researchers. They use data from real-life usage to evaluate the long-term effects of the treatment.

You could receive a new treatment before it is widely available to the public. You provide researchers with information that helps them come up with better treatments. Your treatment costs might decrease because the agency that sponsors the study typically pays for tests and doctor visits related to the trial. It’s a good idea to discuss these costs with your medical team before you start.