Baños J E, Bosch F, Bigorra J, Guardiola E
Departament de Farmacologia i Psiquiatria, Universitat Autònoma de Barcelona.
Med Clin (Barc). 1994 Apr 2;102(12):441-5.
Few studies have evaluated the clinical trials carried out in Spain and published in international journals. The present study has analyzed this situation over the period from 1981 to 1990.
Spanish studies including "clinical trial" as a key word present in Excerpta Medica CD (Drugs and Pharmacology) or MEDLINE in the CD-ROM version were evaluated.
Two hundred forty-one original articles were obtained. The number of clinical trials was relatively stable from 1981 to 1986 (n = 8.15) increasing to a maximum from 1986 to 1988 (n = 64) with a posterior decrease. The languages of publication were English (51%) and Spanish (49%). A significant increase was observed in the number of articles published in English (p < 0.01) in the last five years. Phase III and IV clinical trials were the most frequent (89%) followed by those of phase II (9%) and phase I (2%). The open design predominated in the phase III-IV trials (58%) over the double blind trials (37%) and the single blind trials (5%). Among the former 70% were comparative and 57% followed randomized treatments. The clinical trials were published in 112 journals, Medicina Clínica (n = 32) and Current Therapeutic Research Clinical and Experimental (n = 6) were the most frequently used in Spanish and English, respectively. Two hundred sixty-three drugs were studied in the clinical trials, cisplatin was the most frequently studied (n = 10). The most commonly studied pharmacologic groups were antiinfectious (n = 40) and cytostatic (n = 35). The number of randomized clinical trials increased significantly after 1986 (p < 0.01).
An increase in the number of clinical trials published in international journals was observed with preference for publication in English. The growing presence of randomized double blind clinical trials suggests an improvement in the quality of the clinical trials performed in Spain, particularly after 1986.
很少有研究评估在西班牙开展并发表于国际期刊的临床试验。本研究分析了1981年至1990年期间的这种情况。
对西班牙的研究进行评估，这些研究需在医学文摘光盘（药物与药理学）或光盘版医学索引中含有“临床试验”作为关键词。
共获得241篇原创文章。1981年至1986年临床试验数量相对稳定（n = 8.15），1986年至1988年增至最多（n = 64），随后减少。发表语言为英语（51%）和西班牙语（49%）。在过去五年中，英语发表的文章数量显著增加（p < 0.01）。Ⅲ期和Ⅳ期临床试验最为常见（89%），其次是Ⅱ期（9%）和Ⅰ期（2%）。在Ⅲ - Ⅳ期试验中，开放设计占主导（58%），高于双盲试验（37%）和单盲试验（5%）。在前者中，70%为比较性试验，57%采用随机治疗。这些临床试验发表在112种期刊上，西班牙文最常用的是《临床药物》（n = 32），英文最常用的是《当代治疗研究：临床与实验》（n = 6）。临床试验研究了263种药物，顺铂研究得最为频繁（n = 10）。最常研究的药理学类别是抗感染药物（n = 40）和细胞毒性药物（n = 35）。1986年后随机临床试验数量显著增加（p < 0.01）。
观察到在国际期刊上发表的临床试验数量有所增加，且更倾向于用英语发表。随机双盲临床试验的日益增多表明西班牙开展的临床试验质量有所提高，尤其是在1986年之后。
