A clinical drug trial involves research on humans to see if a drug is effective and to learn about its safety profile. Participation is voluntary and, as this is research, the results cannot be guaranteed.
Yes. Each clinical trial has objectives that may differ from those of another trial, even though they are looking at the clinical response to the same drug.
The development phases involved in research using humans can be classified into four phases.
Participation in a clinical trial is voluntary. Usually, participants contact us through announcements on the website or are people who have previously expressed their interest in taking part. To participate in a clinical trial, the applicant must provide written consent, in addition to meeting all the selection criteria defined in the trial protocol.
In order to do this, nursing and medical members of the research team inform and evaluate the applicant in a consultation, in which they explain what the study involves, answer any questions, and determine whether or not the applicant is eligible to participate in the trial. If the applicant agrees, they sign the informed consent form and are included in the trial.
It is very important that you inform your doctor of any illnesses you have or any treatment you are receiving, as failure to do so may pose a greater risk than is desirable. It is also important to follow the researcher's instructions so that the conclusions drawn from the use of the medicines are realistic.
If you receive healthcare from medical practitioners who are not involved in the trial, it is important that you let them know that you are participating in a clinical trial and, if necessary, provide the necessary information for them to adapt your care to this situation.
Participants can leave a clinical trial whenever they wish or when the researcher decides. Under no circumstances should this affect your medical care.
Participants must receive medical care for any problems that may occur while they are participating in the study. The developer must take out insurance under the conditions set out in the clinical trial regulations.
For a clinical trial to be authorised, it must be adequately justified and explained in terms of the current situation, and be well designed, but participation in a clinical trial does not guarantee results.
Research attempts to answer the question of whether a drug is useful for treating a specific disease with acceptable tolerance. For this reason, there is the possibility, but no certainty, of a beneficial outcome. On the other hand, there could be adverse effects that are not yet known.
As a general rule, healthy people who take part in Phase I trials receive a small compensation for their participation, since the studies are not intended to demonstrate the efficacy of a drug. Everyone who takes part in a trial, in any of the phases, must receive the medication being studied free of charge; this will be provided by the study developer.
Any tests carried out solely for research purposes should not be charged to the participants. Any other tests, not related to the trial, must be paid for.
All clinical trials carried out in Spain are regulated by legal standards, similar to those applied to the rest of the European Community. This guarantees that any clinical trials that are started have been previously evaluated by a Research Ethics Committee for medicines and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS), who ensure that the trial complies with the corresponding ethical, legal and methodological requirements.
Person responsible:
Ana Aldea(ELIMINAR)
Doctor Aiguader, 88
08003 Barcelona
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