Department of General Practice and Family Medicine, University of Goettingen, Humboldtallee 38, 37073 Goettingen, Germany.
Trials. 2011 Apr 1;12:91. doi: 10.1186/1745-6215-12-91.
Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices.
This report is based on the experience of the HWI-01 study conducted in 29 German general 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.
The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial.
To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care.
ISRCTN00470468.
随机对照临床试验(药物)为初级保健中的治疗策略提供了高质量的证据。直到现在,德国全科医学中药物试验的经验还很少。2007/2008 年,作者进行了一项由研究者发起的、非商业性的、双盲、随机对照的初步试验(HWI-01),以评估布洛芬和环丙沙星在治疗单纯性尿路感染(UTI)中的临床等效性。在这里,我们报告了这项试验在德国全科医学中的可行性,以及在主要缺乏经验的全科医学中实施国际协调会议(ICH)定义的良好临床实践(GCP)标准的情况。
本报告基于在 29 家德国全科诊所进行的 HWI-01 研究的经验。可行性定义为 1)成功招募实践,2)足够的患者招募,3)完整准确的数据收集和 4)适当保护患者安全。
最终实践招募率为 18%。在这些实践中,从 195 名筛选出的 UTI 患者中招募了 79 名。招募情况在实践之间差异很大(范围 0-12,平均每个实践 2.8 名患者),低于招募目标约 100 名患者。正如预期的那样,执业护士成为筛选和招募患者的关键人物。临床试验的要求,特别是填写症状问卷、记录原始数据和报告不良事件,与全科医生的记录习惯不一致,需要研究护士的支持。在许多情况下,全科医生和实践工作人员似乎被信息量和规定压得喘不过气来。试验过程中未观察到任何意外的严重不良反应(SUSARs)。
为了在全科医学中开展药物试验,有必要使临床研究基础设施的设置适应全科医生及其实践工作人员的需求。临床试验规定的风险适应是在初级卫生保健中开展非商业性比较疗效试验所必需的。
ISRCTN00470468。