What are the risks?
Despite, that trials are designed and executed with the utmost care, risks are involved:
- lack of efficacy, therefore you do not benefit from participating in the clinical study.
- depending on the kind of clinical study you are participating in, the trial can be time consuming, can include more than one treatment or assessment, it may require you to stay in a hospital or in a research institute for more than one day.
- there is a possibility that you encounter unpleasant or even serious side effects.
When a medicine is not yet registered and you would like to participate in an early phase of research regarding that medicine, there is a possibility that prior to your participation, only a few volunteers have been treated with that medicine. Of course the outcome and results of research with laboratory animals will then have already been reviewed by the investigator and a medical ethics committee, and the risks deemed acceptable.
Regulations regarding clinical trials are quite strict. In very rare cases problems have arisen, as unexpected events occurred. The instances where issues did occur, have provided many lessons to prevent reoccurrences in the future. Phase I clinics ensure the risks are kept to a minimum by following several safety protocols, especially with regards to the first doses.
A well-known example with a very unsuccessful course, was the Phase I study in London in March 2006. It must be said, that these kinds of unsuccessful events are extremely rare. Since the start of modern clinical research, only a couple of these kinds of events are known. The events in London triggered consequences for Phase I studies all over the world to enhance the safety of Phase I studies.
How is my safety ensured?
The ethical and legal regulations, which apply to medical science, also apply to clinical research. Each initiated medical trial must be reviewed and approved by the regulatory authority and an independent Medical Ethics Committee. The medical ethics committee operates independently from the initiating industry, contract research organizations (which guide the research), the examining physician, the research institute and from Link2Trials.
The risks of the trial, the burden you may encounter during the trial and if applicable the financial compensation you may receive for your participation, are all carefully reviewed by the regulatory authority and the medical ethics committee. The trial can only start after written approvals have been received.