Comparison of acceptance of clinical versus basic studies on drugs and therapeutics in infants and children.

G Koren, N Klein
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引用次数: 2

Abstract

Many clinicians and clinician-scientists have serious concerns that clinical studies (i.e. studies with patients) are less favorably accepted than basic ('bench') projects by funding agencies and by promotion committees of university departments. However, this commonly held view has not been previously verified. To test whether bias exists against clinical studies, we compared the acceptance rate of clinical vs. basic studies dealing with drugs and therapeutics in children, which were submitted to a large scientific meeting. Of 197 abstracts reporting on drug/therapeutic studies, submitted to the Society for Pediatric Research in 1993, there were 133 clinical and 64 basic studies. Fifty-nine (44.3%) of the clinical studies were accepted, significantly less than the basic projects (n = 47 or 73.4%, p < 0.0001). A basic paper was 66% more likely to be accepted (95% CI 50.7-82.6%). This trend was consistent for different groups of drugs/therapeutics, including analgesics, surfactants, corticosteroids, vaccines, hormones, and antiasthmatics. To examine whether the lower rate of acceptance of clinical papers is the result of lower scientific standard, all papers were scored for their quality by raters who were blinded to their acceptance or rejection status. In general, rejected clinical papers scored significantly higher than rejected basic papers (16 +/- 1.8 vs. 14.8 +/- 1.0, p < 0.05). Our study supports the commonly held but previously unproven view that there is a bias against clinical research, in the context of patient-based studies, when compared to basic (bench) research.

婴儿和儿童对药物和治疗的临床和基础研究的接受程度比较。
许多临床医生和临床科学家严重担心,临床研究(即对患者的研究)在资助机构和大学院系推广委员会的接受程度上不如基础(“实验”)项目。然而,这种普遍持有的观点以前并没有得到证实。为了检验临床研究是否存在偏见,我们比较了儿童药物和治疗的临床研究和基础研究的接受率,这些研究提交给了一个大型科学会议。1993年提交给儿科研究学会的关于药物/治疗研究的197份摘要中,有133份是临床研究,64份是基础研究。59项临床研究(44.3%)被接受,显著少于基础项目(n = 47或73.4%,p < 0.0001)。基础论文被接受的可能性高出66% (95% CI 50.7-82.6%)。这一趋势在不同类别的药物/治疗药物中是一致的,包括镇痛药、表面活性剂、皮质类固醇、疫苗、激素和平喘药。为了检验临床论文的低接受率是否是科学标准较低的结果,所有论文的质量都由评分者进行评分,评分者对其接受或拒绝状态不知情。总体而言,临床论文被拒得分明显高于基础论文被拒得分(16 +/- 1.8比14.8 +/- 1.0,p < 0.05)。我们的研究支持了一种普遍持有但未经证实的观点,即与基础(实验)研究相比,在以患者为基础的研究背景下,临床研究存在偏见。
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