clinical  trials 

Clinical Trials

Clinical trials are the cornerstone of cancer care – drugs and procedures currently used to treat cancer have to be proven to be safe and effective.

This is why volunteers for clinical trials are closely screened and monitored by their physicians, so treatments can be refined to be the most effective and safest possible. As a brain tumor patient, navigating the process of qualifying for clinical trials can seem mysterious and confusing. It is important to understand the elements that comprise clinical trials.

There are treatment trials – to evaluate whether a new drug, surgery or radiation therapy (or a combination) has a higher success rate than current treatment options. Next are quality-of-life trials – which focus on improving quality of life issues and treatment-related symptoms. And there are prevention, screening and diagnostic trials – which focus on ways to reduce the chances of getting cancer.

Randomized controlled clinical trial

A computer determines the treatment each study participant receives. This ensures that there is no bias in the selection of treatment and that every participant has the same chance of being selected for either the experimental treatment arm (the treatment under investigation) or the standard treatment arm (the usual treatment given for a disease, to which the experimental treatment is being compared). At the end of the trial, the treatment assignments are revealed and researchers can identify whether the experimental treatment was more effective than the standard treatment, and also can compare the side effects of each treatment.

Double-blind clinical trial

In a double-blind trial, neither you nor your oncologist will know whether you are receiving the experimental or standard treatment.  At the end of the trial, the study is “unblinded” and it is revealed which treatment was received by each participant.

Placebo

A placebo is a substance that is given in place of the experimental treatment, but in fact has no active ingredients.   Neither patients nor the oncologist will know which treatment a participant is receiving. Of course if a patient truly needs active treatment, a placebo alone would not be given. It might be given in addition to a standard treatment, to see if the combination of the experimental treatment with the standard treatment is more effective than the standard treatment alone.

The potential risks are weighed against potential benefits. This is why a lot of patients are skeptical of signing up for these trials. But participation is always voluntary and the patient can always withdraw if they feel it best for them. Furthermore, the decision to volunteer or withdraw has absolutely no effect on the patient’s routine medical care.

Risks
Many patients recognize the potential benefits of a clinical trial but are frightened of the risks that may be involved. Patients sign an agreement stating that they know of the potential risks, but withdrawal from the trial is within their right at any point in time – whether it is because they are experiencing too many side effects or are just not happy with the treatment results.