What is a clinical trial?

Clinical trials on our service are conducted on patients to find new treatments or improve existing treatments. All clinical trials are strictly regulated and are reviewed and approved by the government and an independent ethics committee before they can start.

New products go through three major phases of a clinical trial before they can reach the market:

- Phase I: the safety and efficacy of a new drug is tested on a small group of patients. There is an intense follow-up of these patients to monitor the absorption, distribution and degradation of the drug in the body and to verify whether there are any immediate side effects. Different doses of the same drug may be tested in this phase to ascertain the optimal dose. Because the safety of the new drug is closely monitored during this phase and sometimes the right dosage is also being sought, patients cannot simply participate. The company provides places (‘slots’) that can be taken by candidate patients. If all available slots are occupied, new candidates must wait until previously started patients have been treated and followed up for a certain period of time before new slots become available. When and how many slots become available is very difficult to predict as it depends on the reactions seen in already participating patients, in hospitals worldwide.

- Phase II: the drug will be administered to a slightly larger group of patients (20 to 100). In this phase, side effects and the dosing schedule will be further investigated, as well as a first look at whether the results are in line with the expectations.

- Phase III: in a large group of patients (>100), it will be seen whether the drug produces the expected results and whether there are any rare side effects. In some cases, the treatment will be compared with a standard treatment or, if no good alternative is available, a placebo (fake product). This is done to get an objective result on the drug's efficacy. So in a phase III study, it is not always certain that you will receive the drug which is studied.

- Phase IV: after completing the previous phases, the company can apply to market the product. Once the medicine is approved and freely available, further studies are sometimes carried out to see what the long-term results are and if any very rare side effects appear.