Peters-Klimm F, Hermann K, Gágyor I, Haasenritter J, Bleidorn J
Abteilung Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg.
Gesundheitswesen. 2013 May;75(5):321-7. doi: 10.1055/s-0032-1321742. Epub 2012 Aug 14.
Clinical trials are regarded as complex due to the high demands on quality and patient safety and are still exceptional in German primary care. To optimise future trial planning, this study aimed at investigating the barriers and enablers experienced by primary care physicians (PCPs) for trial participation.
PCPs were surveyed on 11 regional primary care medical education (CME) events using a standardised questionnaire. Regression analyses were used to identify predictors for future trial participation.
Of 804 invited PCPs, 408 (50.7%) participated in the survey (51 ± 9 years, female 35%). 69% of participants could imagine their participation in a clinical trial. Of 12 potential factors assessed, the final model retained the 2 predictors (OR; CI; P-value) "research questions relevant to practice" (2.25; 1.61-3.14;<0.001) and "new challenges/change from everyday life" (2.24; 1.67-2.97;<0.001). While 58% of participants were principally willing to participate in investigator training courses according to Good Clinical Practice (GCP), only 6% had participated in such training at the time of answering. Short events were preferred. Only 7% were willing to take over at least half of the costs of these courses.
To enhance German PCPs motivation to participate in clinical trials, both trials and training courses should be tailored to the needs in the primary care setting.
由于对质量和患者安全要求很高,临床试验被视为复杂的,并且在德国初级保健中仍然很罕见。为了优化未来的试验规划,本研究旨在调查初级保健医生(PCP)参与试验所经历的障碍和促进因素。
使用标准化问卷对11个地区初级保健医学教育(CME)活动中的PCP进行调查。采用回归分析来确定未来试验参与的预测因素。
在804名受邀的PCP中,408名(50.7%)参与了调查(年龄51±9岁,女性占35%)。69%的参与者能够想象自己参与临床试验。在评估的12个潜在因素中,最终模型保留了2个预测因素(OR;CI;P值),即“与实践相关的研究问题”(2.25;1.61 - 3.14;<0.001)和“来自日常生活的新挑战/变化”(2.24;1.67 - 2.97;<0.001)。虽然58%的参与者原则上愿意参加根据良好临床实践(GCP)开展的研究者培训课程,但在回答问题时只有6%的人参加过此类培训。较短的活动更受欢迎。只有7%的人愿意承担这些课程至少一半的费用。
为了提高德国PCP参与临床试验的积极性,试验和培训课程都应根据初级保健环境中的需求进行调整。