Should I participate in a clinical trial?

When you need treatment for cancer, you may want to think about joining a clinical trial.

Like all treatment options, clinical trials have possible benefits and risks. During the trial, investigators aim at keeping this risk as low as possible.

POSSIBLE BENEFITS / RISKS

Direct advantage when the new drug turns out to be better than the standard treatment, but the new drug can also turn out to be only better for a certain subgroup of patients.

In some cases, you will have access to a new treatment that is not available to people outside the trial although the benefit of this treatment is already well demonstrated

The new drug could be associated with worse outcome compared to the standard treatment.

Adverse events that are unknown at the start of the trial can emerge when you are participating in the trial.

SCIENTIFIC REVIEW

It is important to point out that clinical trials are only started if there is a realistic chance that the new drug is effective and/or better than the standard of care. In general many experts have worked together while preparing the clinical trial. An ethical committee totally independent from the investigators has also decided that the realization of this trial correspond to ethical standards. An independent data monitoring center evaluates also during most trials that the continuation of the trial is safe. Stopping rules in case of insufficient activity or high incidence of severe toxicities are also defined.

WHAT IS "INFORMED CONSENT"?

When you are participating in a clinical trial, you must give explicit permission for the participation in the trial including receiving the treatment and reporting the outcome. This permission is given through an “informed consent”. Based on the discussion with your doctor, the information on the potential advantages and risks for adverse events, and your personal disease burden, you will have to outweigh the possible advantages and disadvantages of participating in a clinical trial. Ultimately, the decision to participate in a clinical trial remains a choice of the patient.