Clinical trials • Glioma - Center Foundation
Undergoing treatment within clinical trials should be considered carefully since, in fact, it is tantamount to the patient’s agreement to take part in a medical experiment. At the same time, with a disease like glioblastoma, for which there is still no protocol such as might guarantee a cure, it might be the unique chance of success. What are, then, the advantages and disadvantages of participation in clinical tests?
Advantages
availability of a free of charge drug which is potentially effective, since it entered the phase of being tested on people
Disadvantages
risk of being assigned to “placebo group” and thus not receiving the drug
necessity to abandon all other ways of treatment in order to guarantee reliable test results
possibility of various side effects that are not always well researched when the therapy begins
uncertainty as to the actual effect of the therapy
Although disadvantages outnumber advantages, it does not mean that the possibility to participate in clinical trials should be rejected.
Therefore, what particular issues should be considered?
01
phase of clinical tests: the higher it is, the better. Each phase has a different research purpose. For instance, in Phase III it is not only dose toxicity that is tested, since determining the optimum dose is the priority of earlier phases. In Phase III the research focuses upon efficacy or therapeutic effects. With respect to Phases II and III patients should try to contact (e.g. via internet forums) patients who had already been given the drug in question in an earlier phase of testing and gather maximum information
02
placebo group: there are many clinical trials which do not use placebo groups. Information on this issue is always to be found in the description of the study
03
type of drugs tested: it is advisable to profit from past experience: for instance, if the objective of the trial is to test the efficacy of yet another combination of intravenous chemotherapeutics, and if in previous trials great numbers of combinations brought no scientific turn, then there is a high probability that the new one would not prove profitable either.
04
drug availability outside the program as the so-called “compassionate use”: if the drug is available outside a given clinical trial, an alternative solution might be to use the drug individually, following the schema offered in the trial description. This eliminates the risk of being assigned to the “placebo group” and enables the patient to continue treatment. But possible interaction of drugs taken should be discussed with the doctor in charge.
05
necessary and exclusion criteria: these are always to be found in the study description, often making a long list, which is strictly adhered to by medical centers.
06
when the drug is not available outside clinical trials, participation in tests is the only possibility of getting access to it.
How to find a proper study?
Ample information can be found at :
www.clinicaltrials.gov
Go to the homepage and enter relevant data in the search engine. In the fields “Condition” or “Disease” the name of disease should be entered, e.g. glioma, glioblastoma, DIPG. This is enough to obtain a complete list of tests. If one is only interested in the trial of a particular drug or procedure (e.g. immunotherapy), one should complete the “other terms” field. On the first screen, one can limit the search to the home country, when no abroad trip is considered.
When the list of tests is displayed, one can further narrow the field, using the menu given on the left side of the screen. First of all, one should indicate the age and the test status. If the information on test results is needed, the status reads “Completed”. In the case of possible participation in the trials, open programs should be searched, preferably those in the “Recruiting” phase.
When the complete list is displayed, one can look into the description of a particular trial and check whether recruiting conditions are fulfilled. In the case of positive verification, one should contact the person(s) in charge of the trial; in general, the relevant information is provided in the description.
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