Forum for Nordic Dermato-Venereology Nr 3, 2018 | Page 6

Anette Bygum – Establishing a Clinical Trial Unit in Dermato-Venereology at Odense University Hospital, Denmark
angioedema disease mechanisms by genetic engineering in pa-
tient-derived cells.
• Anne Lindegaard Christiansen: Porphyria cutanea tarda: Re-
lations to iron overload, metabolic and cardiovascular diseases
and mortality.
• Stine Bjørn Gram: Improved genetic characterization and diag-
nostics in hereditary palmoplantar keratoderma: A cohort study.
• Azmi Al-Jubury. Schistosome dermatitis in Denmark - Clinical
features, occurrence and diagnostics.
Research Committee, Strategy and Clinical Trial Unit
A Research Committee was established in November 2015
to strengthen the research and strategic priorities at the de-
partment. The committee prepares the department’s research
strategy and contributes to implementing the department’s
and hospital’s research strategy.
The corporate vision is: Clinical research makes life easier for
patients with skin diseases and allergies.
The strategic research areas include:
Adherence, response to treatment, quality of life
Bradykinin mediated Angioedema
Contact dermatitis and contact allergy
Cutaneous lupus erythematosus
Genodermatoses
Hyperhidrosis
Pyoderma gangrenosum
Skin cancer
Teledermoscopy
In 2016 a Clinical Trial Unit (CTU) was formerly established,
initially as “a part time study nurse with a trolley“ (Fig. 1) and
since 2017 with a separate room for clinical studies, two part
time study nurses, a physician one day per week together with
Fig. 2. Head of department inspecting Clinical Trial Unit.
the Clinical Professor and head of the department (Fig. 2).
The CTU performs investigator and sponsor-initiated clinical
research in accordance with responsible conduct of research.
With support from the National Experimental Therapy Part-
nership NEXT (see below), a focus on early phase clinical
studies has been made involving physicians and nurses in
describing standard operating procedures (SOPs). Until now
we have performed 3 sponsored clinical trials within the
field of hereditary angioedema and one clinical trial within
psoriasis. We are preparing another 3 trials within the areas
of angioedema and skin cancer. For many of us, it has been
a learning experience but also a huge work coordinating
the protocols, contracts and economy with sponsor and the
collaboration with pharmacy, clinical chemistry and other
departments such as nuclear medicine and cardiology. Due to
lack of manpower, we have used medical students in the study
team, which seemed to be a very good solution.
Our first clinical study was a phase IIA randomized, dou-
ble-blind, placebo-controlled study to evaluate a small oral
molecule BCX7353 as long-term prophylaxis to reduce attacks
in patients with hereditary angioedema (HAE). With 8 recruit-
ed patients we happened to be the top recruiter among 26
sites in Europe, Canada and Australia and we are very much
looking forward to the publication of study results in NEJM
(paper accepted).
The Research Committee and CTU now serve as a platform and
knowledge base also for investigator initiated projects. Since
November 2015 a total of 27 different research protocols have
been approved by the Research Committee. The committee
seeks to have a high information level in the department and
publishes quarterly newsletters to inform all staff about the
activities, new rules and funding possibilities (Fig. 3).
Fig. 1. Study nurse with her trolley and binders.
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U niversity C linics in the N ordic C ountries
Research should be part of the culture of a university hospital
and all employees should take a responsibility for research.
Some contribute to the framework and logistics, while oth-
Forum for Nord Derm Ven 2018, Vol. 23, No. 3