Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices.
Randomised controlled clinical (drug) trials supply high quality evidence fortherapeutic strategies in primary care. Until now, experience with drug trials inGerman general practice has been sparse.
In 2007/2008, the authors conducted aninvestigator-initiated, non-commercial, double-blind, randomised controlled pilottrial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in thetreatment of uncomplicated urinary tract infection (UTI). Here, we report thefeasibility of this trial in German general practices and the implementation of GoodClinical Practice (GCP) standards as defined by the International Conference onHarmonisation (ICH) in mainly inexperienced general practices.
Methods:
This report is based on the experience of the HWI-01 study conducted in 29 Germangeneral practices.
Feasibility was defined by 1) successful practice recruitment, 2)sufficient patient recruitment, 3) complete and accurate data collection and 4)appropriate protection of patient safety.
Results:
The final practice recruitment rate was 18%. In these practices, 79 of 195 screenedUTI patients were enrolled.
Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal ofapproximately 100 patients. As anticipated, practice nurses became the key figures inthe screening und recruitment of patients.
Clinical trial demands, in particular forcompleting symptom questionnaires, documentation of source data and reporting ofadverse events, did not agree well with GPs'documentation habits and required- 3 -support from study nurses. In many cases, GPs and practice staff seemed to beoverwhelmed by the amount of information and regulations.
No sudden unexpectedserious adverse reactions (SUSARs) were observed during the trial.
Conclusions:
To enable drug trials in general practice, it is necessary to adapt the setup of clinicalresearch infrastructure to the needs of GPs and their practice staff. Risk adaption ofclinical trial regulations is necessary to facilitate non-commercial comparativeeffectiveness trials in primary health care.Trial registration number: ISRCTN00470468
Author: Ildiko GagyorJutta BleidornKarl WegscheiderEva Hummers-PradierMichael Kochen
Credits/Source: Trials 2011, 12:91
Published on: 2011-04-01
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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