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Any experiment planned that includes
patients, and is designed to ascertain the best treatment for future
patients, evaluating the medical intervention or surgical efficacy.
The experiments should be planned and conducted under pre-established
conditions to provide final answers to well definite questions.
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The clinical trials are important because currently they constitute
the most adequate form of investigation of new treatments to prevent,
to lighten or to cure illnesses.
Why could a patient be interested in participating in a clinical trial?
There
are several reasons for which he/she can be interested in participating
in a clinical trial: to contribute to an investigation that can help
others, but it is also possible, to improve the course of his illness,
to be better or to live longer in the cases of certain illnesses.
All the patients that participate in clinical trials are taken care
of in great detail by their doctor during the trial and a time later.
In
the case that it is proved that the treatment investigated is better
than the existing ones, the patients that participated in the clinical
trial would be the first to be benefited from it.
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Every trial can have risks or possible adverse effects related to
the treatment. The possible risks will be reported by their doctor
prior to their participation in the study.
You should value the benefits that the investigation can contribute
with, so much personal as for future patients, as well as the potential
and known risks that you may willing to run.
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The Reported Consent is a process that consists of the following
thing: your doctor will tell you in understandable and adequate words
information on the clinical trial in which he suggests that the patient
participates, with the risks and possible benefits, so that you decide
freely if whether you want to participate.
You will be delivered a
document that contains all this information that you should read very
carefully and ask your doctor all the doubts that you have. Later,
if you agree to take part in the trial, you can sign it. Signing the
Reported Consent does not mean that you are obliged to continue to
the end.
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If you are free to decide your participation in a trial, you have
the same liberty to abandon it when you deem it suitable, without having
to justify and without a repercussion in your medical attention.
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Every clinical trial has to be adjusted to the laws that protect
the rights of the patients. In Spain, “The Law of the Medicine” regulates
in what conditions clinical trials can be carried out giving the maximum
guarantees to the patients.
The medicine that is studied has to have been approved previously by
the Ministry of Health, which only authorizes it when all the requirements
of experimentation with animals and healthy volunteers have been completed.
Moreover, in each hospital there is a Clinical Investigation Ethics
Committee made up by doctors, nurses and other non sanitary professionals
as lawyers, social workers, etc. that revise in great detail the trial
suggested approving it or not.
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Every clinical trial should follow a protocol called action plan
in which everything that must be done is detailed.
There are trials that seek to know the safe dose of the medicine.
Other trials test the efficacy of a new treatment in groups of patients
to decide if it is worth while to continue investigating this treatment
in more extensive studies. Many trials are used in order to compare
two different treatments in two groups of patients.
If there already
is an adequate treatment, this will be compared with the new treatment.
In order that results turn out to be reliable, the patients are assigned
by chance to one of the groups of treatment (randomizing).
Sometimes,
neither the patient nor the doctor knows what treatment is the one
that he has been assigned to. |
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