Safety risks

What are the risks?

Although trials are designed and executed with the utmost care, participating does carry some risks:

- the treatment is not effective, i.e. you do not benefit from participating in the clinical study.

- depending on the kind of clinical study, participating in it can be time-consuming, may involve receiving more than one treatment or assessment and may require you to stay in a hospital or in a research institute for more than one day.

- the treatment may have unpleasant or even serious side effects.

If a medicine is not yet registered and you would like to participate in an early phase of research for that medicine, keep in mind that only a few volunteers may have been treated with that medicine previously. Of course the outcome and results of research using laboratory animals will have already been reviewed by the investigator and a medical ethics committee, and the risks will have been deemed acceptable.

Regulations applying to clinical trials are quite strict. Problems have arisen in rare cases in which unforeseen events occurred. Many lessons have been learned from such instances which will help prevent recurrences in future. Phase I clinics ensure the risks are kept to a minimum by following several safety protocols, especially regarding the initial doses.

A phase I study performed in March 2006 in London is a well-known example of a trial with unintended results. It should be noted that such incidents are extremely rare. Since the start of modern clinical research, only a few such incidents have been reported. The events in London led to worldwide efforts to increase the safety of phase I studies.

How is my safety protected?

The ethical and legal regulations applying to medical science also apply to clinical research. All medical trials initiated must be reviewed and approved by the regulatory authority and an independent medical ethics committee. The medical ethics committee operates independently of the initiating industry, contract research organisations (which supervise the research), the examining doctor, the research institute and Link2Trials.

The risks of the trial, the burden you experience as a participant and, any financial compensation you may receive, are all carefully reviewed by the regulatory authority and the medical ethics committee. The trial can only start after receipt of the required written approval.

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