Kent David M, Mwamburi D Mkaya, Bennish Michael L, Kupelnick Bruce, Ioannidis John P A
Institute for Clinical Research and Health Policy Studies, Department of Medicine, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Mass.
JAMA. 2004 Jul 14;292(2):237-42. doi: 10.1001/jama.292.2.237.
The minimum standard of care required for participants in clinical trials conducted in resource-poor settings is a matter of controversy; international documents offer contradictory guidance.
To determine whether recently published trials conducted in sub-Saharan Africa met standards of care consistent with best current clinical standards for human immunodeficiency virus (HIV) treatment, tuberculosis treatment, and malaria prevention.
Trials published during or after January 1998 that were indexed at the time of the MEDLINE and Cochrane Controlled Trials Register Search (November 20, 2003).
All randomized clinical trials that were conducted in sub-Saharan Africa in 3 clinical domains: HIV disease, tuberculosis treatment, and malaria prophylaxis.
To establish criteria for best current standards of care, evidence from the literature and published guidelines accepted for well-resourced settings were analyzed; the actual care offered in the trial was then compared with these standards.
A total of 128 eligible articles described data from 73 different randomized clinical trials. Only 12 trials (16%) provided care that met guidelines to both intervention and control patients. Only 1 of the 34 trials that enrolled patients with HIV disease provided antiretroviral treatment that conformed to guidelines. Conversely, all tuberculosis treatment trials (n = 13, including 3 for HIV-infected patients) provided tuberculosis therapy that conformed to guidelines. Twenty-one (72%) of 29 malaria prophylaxis trials tested interventions that met guidelines, but only 3 (10%) used any active prophylactic intervention in the control group. Of the 59 trials (81%) that reported on the process of ethical review, all were reviewed by a host African institution and 64% were additionally reviewed by an institution in a developed country.
Rates of adherence to established clinical guidelines of care in randomized clinical trials of HIV treatment, tuberculosis treatment, and malaria prophylaxis varied considerably between disease categories. In determining clinical standards for trials in sub-Saharan Africa, researchers and ethics committees appear to take the local level of care into account.
在资源匮乏地区开展的临床试验中，参与者所需的最低护理标准存在争议；国际文件提供了相互矛盾的指导意见。
确定近期在撒哈拉以南非洲地区开展的试验是否符合与当前人类免疫缺陷病毒（HIV）治疗、结核病治疗和疟疾预防最佳临床标准相一致的护理标准。
1998年1月及以后发表且在MEDLINE和Cochrane对照试验注册库检索时（2003年11月20日）被索引的试验。
在撒哈拉以南非洲地区3个临床领域开展的所有随机临床试验：HIV疾病、结核病治疗和疟疾预防。
为确立当前最佳护理标准的标准，分析了来自文献的证据以及资源充足地区认可的已发表指南；然后将试验中实际提供的护理与这些标准进行比较。
共有128篇符合条件的文章描述了来自73项不同随机临床试验的数据。只有12项试验（16%）为干预组和对照组患者提供了符合指南的护理。在纳入HIV疾病患者的34项试验中，只有1项提供了符合指南的抗逆转录病毒治疗。相反，所有结核病治疗试验（n = 13，包括3项针对HIV感染患者的试验）提供的结核病治疗均符合指南。29项疟疾预防试验中有21项（72%）测试的干预措施符合指南，但对照组中只有3项（10%）使用了任何积极的预防干预措施。在报告伦理审查过程的59项试验（81%）中，所有试验均由非洲当地机构进行了审查，64%还由发达国家的机构进行了额外审查。
在HIV治疗、结核病治疗和疟疾预防的随机临床试验中，对既定临床护理指南的遵循率在不同疾病类别之间差异很大。在确定撒哈拉以南非洲地区试验的临床标准时，研究人员和伦理委员会似乎考虑了当地的护理水平。
