Medical Hydrology and Balneology: Environmental Aspects

How to build a clinical trial?
Forestier R (1) , Françon A (1) , Berköz FB (1)
(1) Centre for Rheumatology and Balneotherapy Research, Aix Les Bains, France
romain.forestier@wanadoo.fr
Introduction and Objectives
Practical building of a clinical trial.
Materials and Methods
Financial support
The first step is to find a financial support. You need to calculate the cost of trial
which directly depends on the number of included patients (it will be described
below).
Writing the protocol
Introduction
Background of the article should be written at this moment. The author must
have detailed knowledge about the subject which will be provided by an extensive
bibliography search.
Eligibility criteria
They are, if possible, validated classification criteria obtained from the literature.
The author should think about all possible restrictions that could introduce a bias
during collection of the data.
Intervention
Interventions should be standardized and precisely described in the protocol. It is
better to meet the therapists to learn exactly how the treatment will be applied.
Outcomes
Choice of the primary outcome. The researcher must analyze the literature to
know what the recommended outcomes for the pathology are. If it is not available
or relevant, it is better to choose a qualitative outcome.
Sample size
Sample size calculation is very important to minimize the risk of negative result
by lack of statistical power. The financial cost of the study is proportional to sample
size. The author must estimate or evaluate the proportion of improved patient in the
treatment and the control group and apply the Casagrande & pike formula. An
example of research financial calculation will be given.
Randomization
Sequence generation must be really random. We will give some example of real
random and not real random procedures. We will give some method to implement
the allocation concealment.
Balnea
2012, núm. 6, 83-84
83
ISBN: 978-84-669-1887-0
978-84-669-3482-4