Abstract:
:The recent increase in funding for diseases endemic in resource-poor countries has led to a progressive rise in the number of trials conducted in Africa for product development purposes or to answer important questions on reduction of disease burden. This causes an increasing demand for data safety monitoring boards (DSMBs) within Africa, where there is currently a shortage of appropriately skilled people. To address this, and in line with capacity-building efforts directed at improved quality research, AMANET invited the authors to create a curriculum and to train selected Africans with the skills required for members of DSMBs. Based on experience, the facilitators made an overview of clinical trial designs, a comprehensive review of data safety monitoring guidelines and other relevant DSMB governance issues. The wealth of guidelines and recommendations available for establishing and running DSMBs focus mainly on trials set in developed countries. The authors drew from these guidelines a practical summary of those relevant for Africa. This interactive process enabled recommendation of a straightforward set of principles to guide the establishment of DSMBs in Africa, which strike that essential balance between protecting trial participants and allowing investigators to answer their scientific questions.
journal_name
Trans R Soc Trop Med Hygauthors
Lang T,Chilengi R,Noor RA,Ogutu B,Todd JE,Kilama WL,Targett GAdoi
10.1016/j.trstmh.2008.06.009subject
Has Abstractpub_date
2008-12-01 00:00:00pages
1189-94issue
12eissn
0035-9203issn
1878-3503pii
S0035-9203(08)00269-1journal_volume
102pub_type
杂志文章abstract::Eleven heterogeneous patients with inoperable hydatid disease were treated with high doses of oral mebendazole, up to 200 mg/kg/day for 16 to 48 weeks. Toxicity was not encountered. Despite careful assessment it proved difficult critically to evaluate the efficacy of mebendazole. In four patients chemotherapy appeared...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(82)90151-1
更新日期:1982-01-01 00:00:00
abstract::This study was carried out to determine the role of non-biting cyclorrhaphan flies as carriers of human intestinal parasites at Woreta, northwestern Ethiopia. In total, 6530 flies were collected from four breeding sites and then examined for human intestinal parasites, mainly using the formol-ether concentration metho...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/j.trstmh.2008.08.010
更新日期:2009-02-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
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更新日期:2002-03-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
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abstract::Several trachoma surveys conducted in sub-Saharan countries showed different geographical distributions of active trachoma and trichiasis. Trichiasis is more common in southern regions. We analysed the role of geoclimatic factors in determining the distributions of active trachoma and trichiasis in Mali. In each regio...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/j.trstmh.2007.05.015
更新日期:2007-10-01 00:00:00
abstract:BACKGROUND:Human T cell lymphotropic virus type 1 (HTLV-1) infection has been associated with recurrent and disseminated strongyloidiasis and adult T cell leukemia/lymphoma (ATLL). METHODS:We compared immunological aspects and markers for ATLL in HTLV-1 patients with or without strongyloidiasis, and evaluated the infl...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1093/trstmh/trt052
更新日期:2013-08-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(87)90378-6
更新日期:1987-01-01 00:00:00
abstract::In South Africa, in urban but not rural areas, hypertension is far more common in Black than in White adults. To throw light on this adverse situation, blood pressures are being determined in various segments of Black populations, in the present instance on series of school pupils aged 16 to 17 years, in rural and urb...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(80)90147-9
更新日期:1980-01-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(76)90009-2
更新日期:1976-01-01 00:00:00
abstract::This paper is a report of the first year of follow-up on 250 pre-school children in a village in Ghana. The mean weight for age and the mean height for age at the start of the study, ranged between 81 and 97% and 91 and 101.4% of the median WHO reference standards respectively. Classified according to Waterlow (1973) ...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(86)90012-x
更新日期:1986-01-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(88)90280-5
更新日期:1988-01-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(87)90311-7
更新日期:1987-01-01 00:00:00
abstract::1,003 patients with meningococcal disease admitted to a single hospital during the course of a three-month epidemic were studied. A progressive decline in mortality, especially among patients with acute meningococcaemia, and a falling incidence of systemic and severe neurological complications among patients with meni...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(79)90053-1
更新日期:1979-01-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章,评审
doi:10.1093/trstmh/tru198
更新日期:2015-01-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1093/trstmh/trw050
更新日期:2016-08-01 00:00:00
abstract::Indigenous natural drugs are in common use in Zimbabwe because modern life-saving drugs are beyond the reach of nearly 85% of the population. These natural drugs have caused a number of poisoning cases. In a study of the records of four hospitals from 1971 to 1982, carried out to see how many people had been poisoned ...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(86)90339-1
更新日期:1986-01-01 00:00:00
abstract::In Anopheles gambiae, as in most species of mosquitoes, mating is initiated in flight. The males aggregate in aerial swarms and conspecific females individually fly to these swarms where they mate with males. In this study, we investigated the swarming behaviour of A. gambiae and conducted 2 surveys in the rice field ...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/s0035-9203(03)80110-4
更新日期:2003-11-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章,随机对照试验
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更新日期:2015-02-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章,评审
doi:10.1016/j.trstmh.2008.05.028
更新日期:2008-09-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0035-9203(00)90130-5
更新日期:2000-07-01 00:00:00
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journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(91)90141-k
更新日期:1991-01-01 00:00:00
abstract::In order to estimate the importance as a public health problem of skin diseases, we investigated the prevalence and severity of skin diseases in a representative sample of children in Mali. 1817 children were randomly selected in 30 clusters by probability-proportional-to-size sampling in Koulikoro region. The mean pr...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(95)90068-3
更新日期:1995-09-01 00:00:00
abstract::A variety of neurological manifestations of infection with Burkholderia pseudomallei have been described including cerebral abscesses, which are a well-recognized form of neurological melioidosis. The optimal antibiotic therapy for this condition has not been defined; however, combinations of intravenous antibiotics a...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/s0035-9203(02)90248-8
更新日期:2002-01-01 00:00:00
abstract::A cohort of 48 Gambian children was protected against malaria by fortnightly administration of Maloprim (pyrimethamine and dapsone) for 2 years between their 3 and 5 birthdays. A matched cohort of 47 children received placebo. During the year following the termination of prophylaxis there was no increase in the freque...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 临床试验,杂志文章
doi:10.1016/0035-9203(88)90263-5
更新日期:1988-01-01 00:00:00
abstract:Background:HIV-associated TB is a serious public health problem in Myanmar. Study objectives were to describe national scale-up of collaborative activities to reduce the double burden of TB and HIV from 2005 to 2016 and to describe TB treatment outcomes of individuals registered with HIV-associated TB in 2015 in the Ma...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1093/trstmh/trx073
更新日期:2017-09-01 00:00:00
abstract::We investigated whether the polymerase chain reaction (PCR) performed with aspirates of bone marrow or lymph node can be used as a test of cure of visceral leishmaniasis (VL). Sixty-one VL patients who had received supervised treatment with sodium stibogluconate in the health centre of Médecins sans Frontières (MSF) H...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/s0035-9203(98)91063-x
更新日期:1998-07-01 00:00:00
abstract::A possible association between nutritional status and Schistosoma mansoni infection or morbidity was investigated by comparing anthropometric indices among 362 children from 3 primary schools in Machakos District, Kenya. Matithini was a prosperous school in an area (Kangundo) of moderate intensity of schistosome infec...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/0035-9203(92)90305-v
更新日期:1992-05-01 00:00:00
abstract::There is an increasing need to provide spatial distribution maps of the clinical burden of Plasmodium falciparum malaria in Africa. Recent evidence suggests that risk groups and the clinical spectrum of severe malaria are related to the intensity of P. falciparum transmission. Climate operates to affect the vectorial ...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/s0035-9203(98)90781-7
更新日期:1998-11-01 00:00:00
abstract::The objectives of this study were to establish the prevalence of Chagas' disease among HIV seropositive patients and to define the clinical profile of co-infected cases. Cross-sectional study: the prevalence of co-infected subjects was 1.3% and there was no significant difference between co-infected and non co-infecte...
journal_title:Transactions of the Royal Society of Tropical Medicine and Hygiene
pub_type: 杂志文章
doi:10.1016/j.trstmh.2010.02.004
更新日期:2010-07-01 00:00:00