Background Clinical trials lead to the development of new drugs and new indications for existing ones. It is important to know the design of clinical trials to interpret and evaluate the results when applying them to clinical practice.
Purpose To characterise the main design aspects of clinical trials (CT) managed in the pharmacy department of a tertiary hospital.
Material and methods This was a retrospective descriptive study of the activity of the clinical trials unit (CTU), from October 2014 to September 2015. Clinical trials that were initiated between 1 January 2014 and 15 October 2015 were included. For each, we collected the phase of the CT, design (randomised/non-randomised, blinded or unblinded, controlled/uncontrolled), treatment arms and control arm (if applicable), and the automation handling of the CT samples (such as drugs provided by the sponsor and in the custody of the CTU of the pharmacy department). In addition, the type of promoter responsible for the development of the CT and the type of patient recruitment was studied. Information was obtained from internal records of the CTU (Gidec), from source documents and from documentation pertaining to each study.
Results In the period studied, 197 clinical trials were initiated (98 in 2014 and 99 in the study period of 2015). Of these, 105 were phase III, 59 phase II, 17 phase I, 11 phase IV and in 4 cases two phases were combined. In terms of design, 73.6% were randomised, 41.1% were double blind (the remainder open label), 74.6% were controlled (with one or more control arms) and of these 45.5% were placebo controlled. For 74.1% of CT, sample management was controlled automatically through IWRS (Interactive Web Response System). In 35 of the CT, the sponsor was an independent industry research entity. The type of recruitment was competitive in 92.4% of cases—that is, the site investigator might include in the CT as many patients as possible until the sample size was complete.
Conclusion The predominant type was a phase III randomised, open, controlled (both placebo and standard treatment) trial, with type of recruitment predominantly competitive. There was considerable informatisation (IWRS), and industry was responsible for the development of clinical trials in most cases.
No conflict of interest
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