Giuseppe
Emeritus
[From ISTITUTO SUPERIORE DI SANITA' - MINISTERO DELLA SANITA' - ITALIA - ORIGINAL ENGLISH TEXTS EDITORIAL - IOH]
The first part of this fourth issue of the Supplement of Notiziario dell'Istituto Superiore di Sanit? is focused on a sensitive and core topic in clinical research: the role of patients in clinical research and their interaction with the clinician/researcher.
This topic is rich in implications, not only from a medical-scientific point of view.
It is also rich in consequences involving the defence of citizens? rights, freedom, and active participation.
The risk of turning persons into test animals can be averted only through a real Copernican revolution, able to consider patients as research subjects, not as objects, and recognizing the benefit of their active involvement in research results.
This change is hardly put into practice in daily activities, but it has always been the core topic worldwide, as reported more and more often in literature, in the scientific community debate, in which the issue of
participation in clinical research is starting to stand out.
For this reason it is necessary to reformulate our vocabulary, the daily language.
People should start talking about testing ?with? humans and not ?on? humans, as suggested by Giulio Maccaro in the introduction to ?Cavie umane? [Human guinea pigs], the volume by M.H. Pappworth focused on the issue of collaboration between medical doctors and patients seen as a starting point to set up research, read results, help understanding
the most urgent needs and the most severe side effects, gather reliable data and evaluate life quality.
The role of ?patients? is really central in the rare diseases world.
The National Centre for Rare Diseases (CNMR), through the activities of the Consulta (Council of patients' Associations), turned this issue into an opportunity to improve the ability to act and guarantee effectiveness of
interventions.
The constant sharing and collaboration between CNMR and the Consulta enriched the activity of researchers and health professionals.
Without the involvement and participation of patients with rare diseases and their families, the Centre would suffer a delay not only in terms of rights but also, and most important, in terms of ability to act and effectiveness of intervention.
This constant relationship, also with the Associations? world, is the reason that made the CNMR become coordinator of the international project EUROPLAN (European Project for Rare Diseases National Plans development).
The Italian situation is in the forefront with regard to this debate, but this is not for other European countries.
In spite of the progress achieved in recent years in the rare diseases field, a global public health approach is still absent in several countries, that face the problem with incomplete and sometimes ineffective strategies.
This is the reason why the EUROPLAN project started:
-- to elaborate recommendations enriched with a direct and coordinated dialogue with Member States.
EUROPLAN is coordinated by the National Centre for Rare Diseases.
This is an important acknowledgment by the European Commission, underlining how the activity of the Centre has become an international
reference point.
The ?Italian model? is based on a national network for rare diseases made of accreditated centres identified by each Region.
In Issue 3 of the Supplement, after the description of the Piedmont Region
experience, in this issue the journey continues in the Lombardy, a Region that counts with 29 centres for rare diseases.
In conclusion, a section is devoted to the patients' Associations, the heart of the rare diseases universe. In this issue four experiences
will be presented: Associazione Italiana Osteogenesi Imperfetta, Associazione Italiana Leucodistrofie Unite, Associazione volontaria per la lotta, lo studio e la terapia dell?Angioedema ereditario e Associazione Malati Anemia Mediterranea Italiana.
The last words are reserved to persons who personally live the difficulties that a rare disease raises, and to their families or close friends.
The last section in fact is dedicated to the narrative-based medicine, the
database gathering the direct experiences of those who face difficulties and in spite of them ?never lose hope?.
Domenica Taruscio
Responsible of the National Centre for Rare Diseases
Focus. Participating in clinical research.
Research that involves human beings is always the best and most responsible way of finding answers to different unmet needs or of acquiring new knowledge, although unfortunately this situation evokes scenarios of ?exploitation? and denial of human rights due to the countless number of accidents occurred.
Therefore, participating in the different types of research that directly or indirectly have clinical relevance should be the present or future common practice, which will nonetheless contribute to the advancement of knowledge. Within the medical environment the debate and literature concerning the idea of ?participation? in this context has increased, thus revealing the distance that remains to be covered, and substantially stating its absence.
The fact that clinical and non clinical research may benefit from patient
and consumer involvement has been emphasized in the past several years.
It is also definitely true and easily proven that the knowledge, expertise, and resources of the involved community are often key to successful research.
-
http://www.iss.it/binary/publ/cont/Notiziario_WEB2008.1216731183.pdf
-------
The first part of this fourth issue of the Supplement of Notiziario dell'Istituto Superiore di Sanit? is focused on a sensitive and core topic in clinical research: the role of patients in clinical research and their interaction with the clinician/researcher.
This topic is rich in implications, not only from a medical-scientific point of view.
It is also rich in consequences involving the defence of citizens? rights, freedom, and active participation.
The risk of turning persons into test animals can be averted only through a real Copernican revolution, able to consider patients as research subjects, not as objects, and recognizing the benefit of their active involvement in research results.
This change is hardly put into practice in daily activities, but it has always been the core topic worldwide, as reported more and more often in literature, in the scientific community debate, in which the issue of
participation in clinical research is starting to stand out.
For this reason it is necessary to reformulate our vocabulary, the daily language.
People should start talking about testing ?with? humans and not ?on? humans, as suggested by Giulio Maccaro in the introduction to ?Cavie umane? [Human guinea pigs], the volume by M.H. Pappworth focused on the issue of collaboration between medical doctors and patients seen as a starting point to set up research, read results, help understanding
the most urgent needs and the most severe side effects, gather reliable data and evaluate life quality.
The role of ?patients? is really central in the rare diseases world.
The National Centre for Rare Diseases (CNMR), through the activities of the Consulta (Council of patients' Associations), turned this issue into an opportunity to improve the ability to act and guarantee effectiveness of
interventions.
The constant sharing and collaboration between CNMR and the Consulta enriched the activity of researchers and health professionals.
Without the involvement and participation of patients with rare diseases and their families, the Centre would suffer a delay not only in terms of rights but also, and most important, in terms of ability to act and effectiveness of intervention.
This constant relationship, also with the Associations? world, is the reason that made the CNMR become coordinator of the international project EUROPLAN (European Project for Rare Diseases National Plans development).
The Italian situation is in the forefront with regard to this debate, but this is not for other European countries.
In spite of the progress achieved in recent years in the rare diseases field, a global public health approach is still absent in several countries, that face the problem with incomplete and sometimes ineffective strategies.
This is the reason why the EUROPLAN project started:
-- to elaborate recommendations enriched with a direct and coordinated dialogue with Member States.
EUROPLAN is coordinated by the National Centre for Rare Diseases.
This is an important acknowledgment by the European Commission, underlining how the activity of the Centre has become an international
reference point.
The ?Italian model? is based on a national network for rare diseases made of accreditated centres identified by each Region.
In Issue 3 of the Supplement, after the description of the Piedmont Region
experience, in this issue the journey continues in the Lombardy, a Region that counts with 29 centres for rare diseases.
In conclusion, a section is devoted to the patients' Associations, the heart of the rare diseases universe. In this issue four experiences
will be presented: Associazione Italiana Osteogenesi Imperfetta, Associazione Italiana Leucodistrofie Unite, Associazione volontaria per la lotta, lo studio e la terapia dell?Angioedema ereditario e Associazione Malati Anemia Mediterranea Italiana.
The last words are reserved to persons who personally live the difficulties that a rare disease raises, and to their families or close friends.
The last section in fact is dedicated to the narrative-based medicine, the
database gathering the direct experiences of those who face difficulties and in spite of them ?never lose hope?.
Domenica Taruscio
Responsible of the National Centre for Rare Diseases
Focus. Participating in clinical research.
Research that involves human beings is always the best and most responsible way of finding answers to different unmet needs or of acquiring new knowledge, although unfortunately this situation evokes scenarios of ?exploitation? and denial of human rights due to the countless number of accidents occurred.
Therefore, participating in the different types of research that directly or indirectly have clinical relevance should be the present or future common practice, which will nonetheless contribute to the advancement of knowledge. Within the medical environment the debate and literature concerning the idea of ?participation? in this context has increased, thus revealing the distance that remains to be covered, and substantially stating its absence.
The fact that clinical and non clinical research may benefit from patient
and consumer involvement has been emphasized in the past several years.
It is also definitely true and easily proven that the knowledge, expertise, and resources of the involved community are often key to successful research.
-
http://www.iss.it/binary/publ/cont/Notiziario_WEB2008.1216731183.pdf
-------