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发展中国家由行业资助的研究。

Industry-sponsored research in developing countries.

作者信息

Abbas E E

机构信息

Saif Bin Gobash and Ibrahim Bin Hamad Obaidullah Hospitals, Ras Alkhaima, United Arab Emirates.

出版信息

Contemp Clin Trials. 2007 Nov;28(6):677-83. doi: 10.1016/j.cct.2007.02.011. Epub 2007 Mar 23.

Abstract

BACKGROUND

Industry has become an important source of funding for clinical research; guidelines governing the relationship between industry and medical institutions are not clear in developing countries and hence we wanted to test attitudes and practices in those countries and compare them to developed countries. We conducted a survey amongst medical practitioners in developed and Arab countries representing developing countries, in order to document their views towards industry-sponsored research and their actual practice in this regard.

METHODS

A structured questionnaire was distributed by email, mail and through personal contacts. The questionnaire included information on characteristics of the practitioners involved, their attitudes towards industry-sponsored research and their actual practices. The questionnaire was distributed to 510 medical practitioners of countries in both groups. Practitioners representing developed countries were from the United States, United Kingdom, Australia and New Zealand. Those representing developing countries included Arab countries from Asia and Africa.

RESULTS

We found that there were contrasting views and practices between the two groups although more than 80% in both groups agreed that industry-sponsored research is necessary. 69.7% of respondents in developed countries participated in industry-sponsored research while only 30.1% did so in developing countries. Guidelines governing such research were better adhered to in developed countries than in developing countries. Where there were no authors who were not part of investigators in developed countries, 16.3% of industry-sponsored research in developing countries included authors who were not part of the investigators. Research ethics committees were present in 94% and 58% of institutions in developed and developing countries respectively. Review bodies were available in 57% and 41% in developed and developing countries.

CONCLUSIONS

Industry-sponsored research is necessary; it is much more common in developed countries. Clear guidelines governing industry-sponsored research should be adopted in developing countries, including the establishment of research ethics committees and review bodies to monitor such research.

摘要

背景

制药行业已成为临床研究的重要资金来源;在发展中国家,关于制药行业与医疗机构关系的指导方针并不明确,因此我们希望调查这些国家的态度和做法,并与发达国家进行比较。我们对代表发展中国家的发达国家和阿拉伯国家的医生进行了一项调查,以记录他们对制药行业资助研究的看法以及他们在这方面的实际做法。

方法

通过电子邮件、邮寄和个人联系分发了一份结构化问卷。问卷包括有关参与医生的特征、他们对制药行业资助研究的态度以及他们的实际做法的信息。问卷分发给两组国家的510名医生。代表发达国家的医生来自美国、英国、澳大利亚和新西兰。代表发展中国家的包括来自亚洲和非洲的阿拉伯国家。

结果

我们发现两组之间存在不同的观点和做法,尽管两组中超过80%的人都认为制药行业资助的研究是必要的。发达国家69.7%的受访者参与了制药行业资助的研究,而发展中国家只有30.1%的人参与。发达国家比发展中国家更严格地遵守此类研究的指导方针。在发达国家,没有不属于研究人员的作者,而在发展中国家,16.3%的制药行业资助研究包括不属于研究人员的作者。发达国家和发展中国家分别有94%和58%的机构设有研究伦理委员会。发达国家和发展中国家分别有57%和41%设有审查机构。

结论

制药行业资助的研究是必要的;在发达国家更为普遍。发展中国家应采用明确的制药行业资助研究指导方针,包括设立研究伦理委员会和审查机构以监督此类研究。

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