“The patient as the protagonist at the center of clinical studies”: this is the theme presented by Elena Bissolotti, Data Manager of Humanitas Cancer Center, during her speech at Mamazone 2017, the seventh edition of “Paziente Diplomata”, a day dedicated to women with and without breast cancer, organized by Humanitas last 14 October.
Clinical studies are a fundamental tool for Research because they allow us to learn more about diseases and build an increasingly effective and specific toolkit to control and combat them.
Characteristics of clinical studies
Experimental clinical studies verify a certain new procedure, drug or therapy by comparing them with those currently in use. However they are conducted, studies must always be designed and carried out with the aim of protection of patient well being and his or her benefit.
In order to be scientifically reliable, however, the studies are controlled; the patients enrolled in fact are divided into different groups: experimental, receiving treatment, or control groups, in which patients are subjected to standard treatment. To ensure scientific rigour, studies are often randomized through assigning each subject to one group or the other independently of their will and the medical staff. The data thus obtained are truly objective, free from expectations and hopes and therefore the differences observed between the groups are attributable only to the treatment or procedure in analysis.
The Ethics Committee and the Italian Medicines Agency
To ensure that patients’ rights are respected, each medical research institute has an Ethics Committee made up of experts, members of the civil community and, hopefully, in the future, also members of patients’ associations. It is a regulatory body established by law to assess scientific relevance and rigour and ensure the protection of the rights, safety and well-being of patients enrolled in clinical trials, while ensuring that the potential benefits of new treatment outweigh the risks.
Another control tool at national level is the Italian Medicines Agency (AIFA), the body that evaluates and authorizes clinical trials of medicines and allows the registration in the European database (EudraCT), which includes all clinical studies and where the results of individual studies are published. AIFA inspects medical research centers, monitoring that the progress of clinical trials is scientifically correct and respectful of patients’ rights.
Clinical studies of yesterday and today
Scientific progress is generally a slow and gradual process, but sometimes there are some lucky exceptions. As the example reported by Dr. Bissolotti of a recent clinical study in which a chemotherapy drug, Trastuzumab, has proved so effective, even in pre-surgical therapies, to enter into current use innovating and thus immediately modifying clinical procedures in the international arena.
To this end, new pharmacological and non-pharmacological studies continue to be carried out, such as some currently open in the Breast Unit of Humanitas: a surgical study, Sinodar One, and a radiotherapy study, Hypab, which, by comparing standard and experimental treatments, share the same fundamental objective: making treatments less and less invasive, with more conservative interventions and lower doses; with the minimum impact on the quality of life and well-being of the patient, preserving the greatest possible effectiveness of treatments.
Participate in an informed manner
Those who choose to enter a clinical trial, therefore, become part of a team, a synergy in which all those involved (patients, doctors, nurses, researchers, control bodies) work together to know, control and combat the disease.
The patient who participates in a clinical trial makes a conscious choice and from the very beginning, is assisted and accompanied to the result and can be proud of having made an important contribution to scientific progress and to the entire community of patients; a contribution that will make it possible, in the future, to develop new drugs for the patients of tomorrow, just as today we benefit from the results of studies conducted in a very recent past.
Watch the speech by Elena Bissolotti, click here.