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Global Collaboration in Dermatology Research www.ifdctn.org
International Federation of
Dermatology Clinical Trials
Networks Newsletter
www.ifdctn.org
Issue 9– April 2015
A Clinical Trial Network for Skin Disease in Italy
Lugi Naldi
Department of Dermatology, Azienda Ospedaliera papa Giovanni XXIII, and Centro Studi
GISED, Bergamo (Italy)
Professor Luigi Naldi (pictured below with members of the GISED network) writes below of his
experiences of working collaboratively in Dermatological based clinical trials in Italy .We hope this
article will give those of you with similar thoughts some inspiration and ideas.
The idea of establishing a clinical research
network focusing on Dermatology, in Italy,
dates back to mid 1980s. That was an exciting
time for collaborative research in the country,
and the National Health System was viewed as
the "natural laboratory" for clinical
epidemiology .
In 1986, the Italian Group for Studying Survival
in Myocardial Infarction (GISSI) successfully
delivered the first results of a multicentre
randomised trial involving more than 80
Cardiologic Departments, showing, on a large
scale, that early thrombolytic therapy reduced
mortality after myocardial infarction .
In the same year, the Italian Group for
Epidemiologic Research in Dermatology
(GISED) was established within the Italian
Society of Dermatology and Venereology
(SIDEV, now SIDEMAST), and a case-control
study of risk factors for lichen planus was
started .
Over the ensuing years, GISED revealed to be
not only a powerful research tool, but also an
effective educational instrument for
dissemination of knowledge on clinical
epidemiology and research methodology in
Dermatology in Italy. More than 50
dermatological centres have participated over
time to the GISED projects, and about 30
students and young medical doctors have
finished their training at the GISED coordinating
centre . Some of them decided to pursue a
professional career in epidemiology and public
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The GISED network
health. The research model adopted was one
moving from etiologic and prognostic studies
assessing risk factors, to the planning of
interventions aimed at reducing the impact of
risk factors on the incidence and prognosis of
skin disease.
This model led to the development of a number
of randomised clinical trials mainly focusing on
non-pharmacological interventions and on the
clinical exploitation of new technologies such as
lasers in specific areas of dermatology. The
main studies developed are summarised in the
Table overleaf . A disease of particular interest
was psoriasis. The research approach started
with a series of case-control studies, and
continued with the establishment of a treatment
registry and a cohort study supported by the
Italian Drug Agency (AIFA) from 2006 to 2010.
It was documented that overweight and obesity were risk
factors for the onset of psoriasis and affected treatment
response and disease outcome. Hence, a randomised
study was planned to assess the impact of a dietetic
intervention combined with physical exercise to reduce
weight in overweight and obese psoriatic patients. The
study was supported by the Emilia-Romagna Region, and
was completed in 2012, showing that the intervention
improved psoriasis beyond the effect of the systemic
treatment received .
References
1. Gruppo Italiano per lo Studio della Streptochinasi
nell'Infarto Miocardico (GISSI). Effectiveness of
intravenous thrombolytic treatment in acute myocardial
infarction. Lancet 1986;1:397-402.
2. Tognoni G, Bonati M. Second-generation clinical
GISED is now celebrating its 30-year activity. The main
ingredients for what I believe is the group success has
been, in my opinion, the combination of a strong
multidisciplinary coordinating capacity with a stable
network of interested people able to guarantee the
optimal application of study methods. Friendship and
mutual respect were also important components of the
GISED success enabling the maintenance of the group at
a rather informal but productive level over many years.
Long live the GISED experience!
pharmacology. Lancet 1986;2:1028-9.
3. Gruppo Italiano Studi Epidemiologici in Dermatologia
(GISED). Lichen planus and liver diseases: a multicentre
case-control study. BMJ 1990;300:227-30.
4. Naldi L, Conti A, Cazzaniga S, et al. Diet and physical
exercise in psoriasis: a randomized controlled trial. Br J
Dermatol. 2014;170:634-42.
Table 1 -Main randomised trials conducted in the framework of
the GISED collaboration
Project name (years)
Description
SoleSi-SoleNo-GISED
A cluster-randomised clinical trial in 122 Italian primary schools (11,230 children
project (2001-2004)
enrolled) to assess the effectiveness of a structured educational intervention to
improve sun exposure behaviour and reduce sunburns and the incidence of
melanocytic nevi in schoolchildren
Randomised trial of excimer
A multicentre randomised trial on the efficacy of excimer laser associated with
laser in vitiligo (2005-2007)
topical steroids in the treatment of vitiligo of the head and neck
Proof of concept study of
A within patient randomised clinical trial of noncultured melanocytes from the
melanocyte transplantation in
outer-rooth sheet of hair follicles in combination with excimer laser in treating
vitiligo (ongoing)
vitiligo of the dorsum of hands
Assessment of the efficacy of
A randomised trial assessing the impact of a structured writing exercise
writing exercises in psoriasis
(Pennebaker's emotional writing) to improve coping and disease activity in 202
(2009-2011)
psoriatic patients from 10 dermatological centres
Diet and physical exercise in
A randomised trial assessing the impact of a dietetic intervention associated with
psoriasis (2011-2012)
physical exercise to improve psoriasis treated by systemic therapies in 303
obese patients.
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Skin Advisory Group– Inaugural meeting announces
Programme of systematic reviews on skin cancer
January saw the first meeting of the advisory group for a UK programme of systematic reviews on the diagnosis and
staging of skin cancer funded by the NIHR. The suite of over 20 diagnostic test accuracy reviews is a collaboration
between the methodological expertise of the Test Evaluation Research Group in Birmingham, and the content
expertise of the Cochrane Skin Group based at Nottingham. The aim of the programme is to extensively investigate
available resources and literature in order to produce definitive reviews on both the diagnosis and staging of
melanoma and keratinocyte skin cancers (basal cell and cutaneous squamous cell carcinomas, also termed
'non-melanoma' skin cancers).
The assembled advisory group, chaired by Professor Hywel Williams from Nottingham, is a collaboration of
members from a number of disciplines, including the Cochrane Skin Group, British Association of Dermatologists,
General Practitioners, NICE, the Birmingham School of Health and Population Sciences, patient and public
representatives and BAPRAS (Mr Hamid Tehrani).
The meeting was an excellent example of the progress that is possible with such collaboration towards the unified
goal of improving skin cancer diagnosis and management. The project is being led by Dr. Jac Dinnes from the
Birmingham team.
Authorship of the reviews is through volunteers, and it was proudly noted that 6 trainees from Plastic &
Reconstructive surgery have been fortunate to be included as authors on this important project.
The project is scheduled to run for the next 2 years, and the results of the reviews are eagerly anticipated.
Written by BAPRAS Representative ,Mr Hamid Tehrani, Consultant Plastic and Reconstructive Surgeon with
the Regional Specialist Skin Cancer Multidisciplinary team, Whiston and St Helens, UK.
The Evidence-Based Research Network
A number of studies show that researchers, research funders, regulators, sponsors
and publishers of research fail to use earlier research when preparing to start, fund,
regulate, sponsor or publish the results of new studies. To embark on research
without systematically reviewing the evidence of what is already known, particularly
when the research involves people or animals, is unethical, unscientific, and
wasteful.
To address this problem a group of Norwegian and Danish researchers initiated an international network, the
‘Evidence-Based Research Network’. The EBRNetwork was established in Bergen, Norway in December 2014 with
initial partners from Australia, Canada, Denmark, the Netherlands, Norway, the UK, and USA.
The aim of the EBRNetwork is to reduce waste in research by promoting:
No new studies without prior systematic review of existing evidence
Efficient production, updating and dissemination of systematic reviews
The EBRNetwork encourages all interested individuals and organisations to join the EBRNetwork and work together
to address this challenge to the very heart and values of research.
Contact the EBRNetwork for more details: [email protected]
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